Acute Myocardial InfarctionAV-MDRNCT04573660
Abbott Vascular Medical Device Registry
An observational study of Acute Myocardial Infarction and Restenoses, Coronary, run by Abbott Medical Devices at 37 sites in 14 countries.
Trial summary
The AV-MDR is a prospective, non-randomized, open-label, multi-center registry. The purpose of the AV-MDR study is to proactively collect and evaluate clinical data on the usage of the devices in scope within their intended use with the aim of confirming safety and performance throughout their expected lifetime… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction, Restenoses, Coronary, Coronary Artery Lesions
- What is being tested?
- Coronary and peripheral stents, Pacing catheters and Vascular plugs
- Type of treatment
- Medical device
- How many people
- 3,784 participants
- Where
- 37 sitesin 14 countries
- Study dates
- 25 Oct 2020to Nov 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will enroll subjects 18 years and older of all genders in which at least one Abbott target device specified in the CIP is used. Outcomes will be collected on any ancillary devices in scope, but patients will not be enrolled for use of an ancillary device without treatment with any target device. Patients must meet all general eligibility criteria and provide written informed consent or be enrolled under an IRB/EC approved waiver of consent, prior to sites' collection of patient data for the investigation.
Who may be able to join
- Subject is at least 18 years of age.
- Subject has a planned procedure, or underwent a procedure, that will use/used one or more Abbott target devices covered in this registry.
- Subject is willing and able to comply with, or has already completed, the follow-up schedule specified in this protocol.
- Subject must provide written informed consent prior to any clinical investigation-related data collection or be enrolled under an IRB/EC approved waiver of consent.
Who cannot join
- 1. Subject has active symptoms and/or a positive test result of COVID-19 or other rapidly spreading novel infectious agent within the prior 2 months of the date of procedure.
Trial locations and contacts
37 sites in 14 countries. Contact the study team or a site near you to ask about taking part.
Chinedu Agbonghai, MS contact
37 sites in 14 countries
United States7 sites, 7 recruiting
- Recruiting
University Hospital - Univ. of Alabama at Birmingham (UAB)
Birmingham, Alabama, 35249
Dr. Mustafa Ahmed
- Recruiting
Northwestern Memorial Hospital
Chicago, Illinois, 60611
James D Flaherty, MD
- Recruiting
Ohio State University
Columbus, Ohio, 43210
Richard Gumina, M.D.
- Recruiting
Wellmont CVA Heart Institute
Kingsport, Tennessee, 37660
Gaurav Rana, MD
- Recruiting
Bryan Heart
Lincoln, Nebraska, 68506
Brock Cookman, M.D.
- Recruiting
Arkansas Heart Hospital
Little Rock, Arkansas, 72211
Vijay Raja, M.D.
- Recruiting
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
Somjot Brar, MD
Germany5 sites, 5 recruiting
- Recruiting
Herz- u. Gefäßzentrum Bad Bevensen
Bad Bevensen, Saxon, 29549
Wulf Euringer
- Recruiting
Cardioangiologisches Centrum am Bethanien Krankenhaus
Frankfurt am Main, Hesse, 60389
Michael Piorkowski
- Recruiting
Universitätsklinikum Schleswig-Holstein Campus Kiel
Kiel, Schlesw, 24105
Dr. Matthias Lutz
- Recruiting
Universitätsklinikum Leipzig AÖR
Leipzig, Saxony, 04103
Prof. Dr. med. Dierk Scheinert
- Recruiting
UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz
Mainz, Rhinela, 55131
Prof. Dr. med. Christine Espinola-Klein
Taiwan4 sites, 4 recruiting
- Recruiting
Taichung Veterans General Hospital
Taichung, Mtaiwan, 40705
Wen Lieng Lee
- Recruiting
National Cheng Kung University Hospital
Tainan, Staiwan, 704
Ju-Yi Chen
- Recruiting
Chi Mei Hospital
Tainan, Staiwan, 710
Zhih-Cherng Chen
- Recruiting
Cathay General Hospital
Taipei, Ntaiwan, 106
Chi-Hung Huang
China3 sites, 3 recruiting
- Recruiting
Jinhua Municipal Central Hospital
Jinhua, Zhejian, 321000
Fengfeng Jiang, M.D.
- Recruiting
Ningbo First Hospital
Ningbo, Zhejian, 315000
Zhiqing Lin
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Jianfeng Han
Italy3 sites, 2 recruiting
- Completed
Ospedale San Raffaele
Milan, Lombard, 20132
- Recruiting
Centro Cardiologico Monzino
Milan, Lombard, 20138
Doctor Galli
- Recruiting
Policlinico San Donato
San Donato Milanese, Lombard, 20097
Francesco Bedogni, MD
Spain3 sites, 3 recruiting
- Recruiting
Hospital General Universitario de Alicante
Alicante, Valncia, 03010
Javier Irurzun
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, Catalon, 08035
Sergi Bellmunt
- Recruiting
Hospital Universitario de la Paz
Madrid, Madrid, 28046
Raul Moreno
Australia2 sites, 2 recruiting
- Recruiting
Perth Institute of Vascular Research
Nedlands, WAUS, 6009
Bibombe Patrice Mwipatayi
- Recruiting
Sir Charles Gairdner Hospital
Nedlands, WAUS, 6009
Carolina Bravo Ceballos
Belgium2 sites, 2 recruiting
- Recruiting
Onze-Lieve-Vrouwziekenhuis Campus Aalst
Aalst, Eflndrs, 9300
Lieven Maene
- Recruiting
AZ Sint-Blasius Ziekenhuis
Dendermonde, Eflndrs, 9200
Koen Deloose
France2 sites, 1 recruiting
- Recruiting
CH Chartres
Chartres, Centre-Val de Loire, 28018
Radwane Hakim
- Completed
Hôpital Paris Saint-Joseph
Paris, Ile, 75014
Switzerland2 sites, 2 recruiting
- Recruiting
Kantonsspital Aarau
Aarau, Basel, 5001
Hans Martin Gissler
- Recruiting
Inselspital - University Hospital of Bern
Bern, Canton of Bern, 3010
Marc Schindewolf, M.D.
Austria1 site, 1 recruiting
- Recruiting
Universitätsklinik Graz
Graz, Styria, 8036
Hannes Deutschmann
Hungary1 site, 1 recruiting
- Recruiting
Semmelweis University
Budapest, Budapest, 1122
Bela Merkely
Netherlands1 site
- Completed
St. Antonius Ziekenhuis
Nieuwegein, Utrecht, 3435 CM
United Arab Emirates1 site, 1 recruiting
- Recruiting
Al Qassimi Hospital
Sharjah city, Emirate of Sharjah, 3500
Arif Al Nooryani
About this study
The AV-MDR is a prospective, non-randomized, open-label, multi-center registry. The purpose of the AV-MDR study is to proactively collect and evaluate clinical data on the usage of the devices in scope within their intended use with the aim of confirming safety and performance throughout their expected lifetime, ensuring the continued acceptability of identified risks, detecting emerging risks on the basis of factual evidence, ensuring the continued acceptability of the benefit-risk ratio, and identifying possible systematic misuse or off-label usage such that the intended use can be verified as appropriate.
- Conditions
- Acute Myocardial Infarction, Restenoses, Coronary, Coronary Artery Lesions, Venous Embolism, Arterial Embolism
- Being tested
- Coronary and peripheral stents, Pacing catheters, Vascular plugs, Measurement and imaging (FFR and OCT), Peripheral dilatation catheters
- Keywords
- Coronary and peripheral stents, ABT-CIP-10349, Vascular plugs, Pacing catheters, Measurement and imaging (FFR and OCT), Peripheral dilatation catheters, Coronary dilatation catheters, Coronary and peripheral guidewires, Vessel closure/compression devices, Vascular access introducers
- Medical subject headings
- Coronary Restenosis, Ornithine Carbamoyltransferase Deficiency Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary and peripheral stentsDevice
The participants in the Coronary and peripheral stents arm will receive Coronary and peripheral stents
Pacing cathetersDevice
The participants in the Pacing catheters arm will receive Pacing catheters
Vascular plugsDevice
The participants in the Vascular plugs arm will receive Vascular plugs
Measurement and imaging (FFR and OCT)Device
The participants in the Measurement and imaging (FFR and OCT) arm will receive Measurement and imaging (FFR and OCT)
Peripheral dilatation cathetersDevice
The participants in the Peripheral dilatation catheters will receive Peripheral dilatation catheters
Coronary dilatation cathetersDevice
The participants in the Coronary dilatation catheters will receive Coronary dilatation catheters
Coronary and peripheral guidewiresDevice
The participants in the Coronary and peripheral guidewires will receive Coronary and peripheral guidewires
Vessel closure/compression devicesDevice
The participants in the Vessel closure/compression devices will receive Vessel closure/compression devices
Vascular access introducersDevice
The participants in the Vascular access introducers arm will receive Vascular access introducers
| Study group | Role | What they receive |
|---|---|---|
| Coronary and peripheral stents | Participants in the Coronary and peripheral stents arm will receive Coronary and peripheral stents Receives: Device: Coronary and peripheral stents | |
| Pacing catheters | Participants in the Pacing catheters arm will receive Pacing catheters Receives: Device: Pacing catheters | |
| Vascular plugs | Participants in the Vascular plugs arm will receive Vascular plugs Receives: Device: Vascular plugs | |
| Measurement and imaging (FFR and OCT) | Participants in the Measurement and imaging (FFR and OCT) arm will receive Measurement and imaging (FFR and OCT) Receives: Device: Measurement and imaging (FFR and OCT) | |
| Peripheral dilatation catheters | Participants in the Peripheral dilatation catheters arm will receive Peripheral dilatation catheters Receives: Device: Peripheral dilatation catheters | |
| Coronary dilatation catheters | Participants in the Coronary dilatation catheters arm will receive Coronary dilatation catheters Receives: Device: Coronary dilatation catheters | |
| Coronary and peripheral guidewires | Participants in the Coronary and peripheral guidewires arm will receive Coronary and peripheral guidewires Receives: Device: Coronary and peripheral guidewires | |
| Vessel closure/compression devices | Participants in the Vessel closure/compression devices arm will receive Vessel closure/compression devices Receives: Device: Vessel closure/compression devices | |
| Vascular access introducers | Participants in the Vascular access introducers devices arm will receive Vascular access introducers Receives: Device: Vascular access introducers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary Stents - Number of participants with composite of all-cause death, MI or target lesion revascularization (TLR)
Composite of all-cause death, MI or target lesion revascularization (TLR) will be assessed among the patients who receive Coronary Stents.
Measured: During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Coronary Stents - Number of participants with composite of all-cause death, MI or target lesion revascularization (TLR)
Composite of all-cause death, MI or target lesion revascularization (TLR) will be assessed among the patients who receive Coronary Stents.
Measured: 30 days
Coronary Stents - Number of participants with composite of all-cause death, MI or target lesion revascularization (TLR)
Composite of all-cause death, MI or target lesion revascularization (TLR) will be assessed among the patients who receive Coronary Stents.
Measured: 12 months
Peripheral Stents - Number of participants with composite of all-cause death, amputation, and TLR
Composite of all-cause death, amputation, and TLR will be assessed among the patients who receive Peripheral Stents.
Measured: During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Peripheral Stents - Number of participants with composite of all-cause death, amputation, and TLR
Composite of all-cause death, amputation, and TLR will be assessed among the patients who receive Peripheral Stents.
Measured: 30 days
Peripheral Stents - Number of participants with composite of all-cause death, amputation, and TLR
Composite of all-cause death, amputation, and TLR will be assessed among the patients who receive Peripheral Stents.
Measured: 12 months
Peripheral Stents (Renal Indication) - Number of participants with composite of all-cause death, ipsilateral nephrectomy, Embolic events resulting in kidney damage or TLR
Composite of all-cause death, ipsilateral nephrectomy, Embolic events resulting in kidney damage or TLR will be assessed among the patients who receive Peripheral Stents (Renal Indication).
Measured: During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Peripheral Stents (Renal Indication) - Number of participants with composite of all-cause death, ipsilateral nephrectomy, Embolic events resulting in kidney damage or TLR
Composite of all-cause death, ipsilateral nephrectomy, Embolic events resulting in kidney damage or TLR will be assessed among the patients who receive Peripheral Stents (Renal Indication).
Measured: 30 days
Peripheral Stents (Renal Indication) - Number of participants with composite of TLR
Composite of TLR will be assessed among the patients who receive Peripheral Stents (Renal Indication).
Measured: 12 months
Pacing Catheters - Number of participants with composite of potential complications (venous thrombosis, pulmonary emboli, arrhythmias, perforation)
Composite of potential complications (venous thrombosis, pulmonary emboli, arrhythmias, perforation) will be assessed among the patients who receive Pacing Catheters.
Measured: During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Pacing Catheters - Loss of capture (assessed based on physiological parameter-ECG)
Loss of capture (average time of loss of capture across patients) will be assessed among the patients who receive Pacing Catheters. ECG is used to measure whether the pacing device stimulates the heart. Absence of a stimulation is considered a loss of capture.
Measured: During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Vascular Plugs - Number of participants with composite of potential complications (Implant success, occlusion success, migration)
Composite of potential complications including implant success, occlusion success, migration will be assessed among the patients who receive Vascular Plugs.
Measured: During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Vascular Plugs - Number of participants with composite of occlusion success and migration
Composite of occlusion success and migration will be assessed among the patients who receive Vascular Plugs.
Measured: 30 days
Fractional flow reserve - Number of participants with composite of vessel dissection, perforation, and thromboembolism
Composite of vessel dissection, perforation, and thromboembolism during procedure will be assessed among the patients who receive Fractional flow reserve (FFR).
Measured: During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Fractional flow reserve - Number of participants with signal drift (Signal drift between measurements (Pd/Pa** pressure drift >0.03; <0.97 or >1.03)
Signal drift (Signal drift between measurements (Pd/Pa** pressure drift >0.03; <0.97 or >1.03) will be assessed among the patients who receive FFR.
Measured: During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Optical Coherence Tomography Products - Number of participants with Intraprocedural complications (number of dissections ≥type B, slow flow or no reflow, thrombus, abrupt closure, perforation)
Intraprocedural complications will be assessed among the patients who receive Optical Coherence Tomography (OCT).
Measured: During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Optical Coherence Tomography Products - Number of participants with Successful crossing and image quality pre-PCI
Successful crossing and image quality pre- PCI will be assessed among the patients who receive OCT.
Measured: During procedure - Before the stent is implanted (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Optical Coherence Tomography Products - Number of participants with Successful crossing and image quality post-PCI
Successful crossing and image quality post-PCI will be assessed among the patients who receive OCT.
Measured: During procedure - Between 10-30 minutes post-PCI (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Peripheral Dilatation Catheters - Number of participants with Composite of major adverse events
Composite of major adverse events (e.g., distal embolization, dissection, perforation, amputation primary to balloon usage, total occlusion, abrupt closure, renal failure primary to balloon usage will be assessed among the patients who receive Peripheral Dilatation Catheters.
Measured: During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Peripheral Dilatation Catheters - Number of participants with Device success (Successful delivery, Successful inflation, Successful deflation, Successful withdrawal) (assessed based on physiological parameters)
Device success (Successful delivery, Successful inflation, Successful deflation, Successful withdrawal) will be assessed among the patients who receive Peripheral Dilatation Catheters. Device success can be summarized as the successful treatment with the device.
Measured: During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Coronary Guidewires - Number of participants with Composite of major adverse events
Composite of major adverse events (e.g., vessel perforation, dissection, occlusion, embolism) will be assessed among the patients who receive Coronary Guidewires.
Measured: During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Coronary Guidewires - Number of participants with Device success (Successfully placed, Successfully introduce/position diagnostic/interventional device, Successfully reach/cross target lesion) (assessed based on physiological parameters)
Device success (Successfully placed, Successfully introduce/position diagnostic/interventional device, Successfully reach/cross target lesion will be assessed among the patients who receive Coronary Guidewires. Device success can be summarized as the successful treatment with the device.
Measured: During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Peripheral Guidewires - Number of participants with Composite of major adverse events
Composite of major adverse events (e.g., vessel perforation, dissection, occlusion, embolism) will be assessed among the patients who receive Peripheral Guidewires.
Measured: During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Peripheral Guidewires - Number of participants with Device success (Successfully placed, Successfully introduce/position diagnostic/interventional device, Successfully reach/cross target lesion) (assessed based on physiological parameters)
Device success (Successfully placed, Successfully introduce/position diagnostic/interventional device, Successfully reach/cross target lesion will be assessed among the patients who receive Peripheral Guidewires. Device success can be summarized as the successful treatment with the device.
Measured: During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Coronary Dilatation Catheters - Number of participants with Composite of major adverse events
Composite of major adverse events (e.g., distal embolization, dissection, perforation, amputation primary to balloon usage, total occlusion, abrupt closure, renal failure primary to balloon usage will be assessed among the patients who receive Coronary Dilatation Catheters.
Measured: During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Coronary Dilatation Catheters - Number of participants with Device success (Successful delivery, Successful inflation, Successful deflation, Successful withdrawal) (assessed based on physiological parameters)
Device success (Successful delivery, Successful inflation, Successful deflation, Successful withdrawal) will be assessed among the patients who receive Coronary Dilatation Catheters. Device success can be summarized as the successful treatment with the device.
Measured: During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Vessel Closure Devices - Number of participants with Composite of access complications
Composite of access complications (e.g., hematoma, stenosis/occlusion, infection, access site bleeding) will be assessed among the patients who receive Vessel Closure Devices.
Measured: During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Vessel Closure Devices - Number of participants with Successful hemostasis Major and minor bleeding
Successful hemostasis Major and minor bleeding will be assessed among the patients who receive Vessel Closure Devices.
Measured: During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Vessel Compression Devices - Number of participants with Major and minor bleeding
Major and minor bleeding will be assessed among the patients who receive Vessel Compression Devices.
Measured: During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Vessel Compression Devices - Number of participants with Complications including: pseudoaneurysm, hematoma (>5cm) in diameter, Hb drop>20 g/L, extended compression time >6 hours, blood transfusion required, bleeding requiring surgical procedure
Complications including: pseudoaneurysm requiring treatment, hematoma (>5cm) in diameter, Hb drop>20 g/L, extended compression time >6 hours, blood transfusion required, bleeding requiring surgical procedure will be assessed among the patients who receive Vessel Compression Devices.
Measured: During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Vascular Access Introducers - Incidence of safety issues
Incidence of safety issues (e.g., bleeding, air embolism, hematoma, vessel damage (dissection, perforation, pseudoaneurysm), infection, thrombosis, AV fistula, occlusion, radial artery spasm) will be assessed among the patients who receive Vascular Access Introducers.
Measured: During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Vascular Access Introducers - Incidence of performance issues
Incidence of performance issues (e.g., unable to introduce other devices, failure to maintain hemostasis valve integrity, air leakage, bending or kinking of introducer, difficulty inserting/removing the sheath, device breakage detachment or separation, issue with an associated accessory) will be assessed among the patients who receive Vascular Access Introducers.
Measured: During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start25 Oct 2020
- Primary completionNov 2030 (estimated)
- Study completionNov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,784 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chananit Hutson, PhD, Study director, Abbott Medical Devices
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04573660
- Sponsor's protocol ID
- ABT-CIP-10349
- Acronym
- AV-MDR
- Status last verified
- Oct 2026
- First submitted
- 23 Sep 2020
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abbott Vascular Medical Device Registry
- ClinicalTrials.gov ID
- NCT04573660
- Acronym / sponsor ID
- AV-MDR / ABT-CIP-10349
- Conditions
- Acute Myocardial Infarction, Restenoses, Coronary, Coronary Artery Lesions, Venous Embolism, Arterial Embolism
- Keywords
- Coronary and peripheral stents, ABT-CIP-10349, Vascular plugs, Pacing catheters, Measurement and imaging (FFR and OCT), Peripheral dilatation catheters, Coronary dilatation catheters, Coronary and peripheral guidewires
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,784 participants (estimated)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 25 Oct 2020 (actual)
- Primary completion
- Nov 2030 (estimated)
- Study completion
- Nov 2031 (estimated)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The AV-MDR is a prospective, non-randomized, open-label, multi-center registry. The purpose of the AV-MDR study is to proactively collect and evaluate clinical data on the usage of the devices in scope within their intended use with the aim of confirming safety and performance throughout their expected lifetime, ensuring the continued acceptability of identified risks, detecting emerging risks on the basis of factual evidence, ensuring the continued acceptability of the benefit-risk ratio, and identifying possible systematic misuse or off-label usage such that the intended use can be verified as appropriate.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Coronary and peripheral stents | – | Device: Coronary and peripheral stentsParticipants in the Coronary and peripheral stents arm will receive Coronary and peripheral stents |
| Pacing catheters | – | Device: Pacing cathetersParticipants in the Pacing catheters arm will receive Pacing catheters |
| Vascular plugs | – | Device: Vascular plugsParticipants in the Vascular plugs arm will receive Vascular plugs |
| Measurement and imaging (FFR and OCT) | – | Device: Measurement and imaging (FFR and OCT)Participants in the Measurement and imaging (FFR and OCT) arm will receive Measurement and imaging (FFR and OCT) |
| Peripheral dilatation catheters | – | Device: Peripheral dilatation cathetersParticipants in the Peripheral dilatation catheters arm will receive Peripheral dilatation catheters |
| Coronary dilatation catheters | – | Device: Coronary dilatation cathetersParticipants in the Coronary dilatation catheters arm will receive Coronary dilatation catheters |
| Coronary and peripheral guidewires | – | Device: Coronary and peripheral guidewiresParticipants in the Coronary and peripheral guidewires arm will receive Coronary and peripheral guidewires |
| Vessel closure/compression devices | – | Device: Vessel closure/compression devicesParticipants in the Vessel closure/compression devices arm will receive Vessel closure/compression devices |
| Vascular access introducers | – | Device: Vascular access introducersParticipants in the Vascular access introducers devices arm will receive Vascular access introducers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will enroll subjects 18 years and older of all genders in which at least one Abbott target device specified in the CIP is used. Outcomes will be collected on any ancillary devices in scope, but patients will not be enrolled for use of an ancillary device without treatment with any target device. Patients must meet all general eligibility criteria and provide written informed consent or be enrolled under an IRB/EC approved waiver of consent, prior to sites' collection of patient data for the investigation.
Key inclusion criteria (4 listed)
- Subject is at least 18 years of age.
- Subject has a planned procedure, or underwent a procedure, that will use/used one or more Abbott target devices covered in this registry.
- Subject is willing and able to comply with, or has already completed, the follow-up schedule specified in this protocol.
- Subject must provide written informed consent prior to any clinical investigation-related data collection or be enrolled under an IRB/EC approved waiver of consent.
Key exclusion criteria (1 listed)
- 1. Subject has active symptoms and/or a positive test result of COVID-19 or other rapidly spreading novel infectious agent within the prior 2 months of the date of procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary and peripheral stentsThe participants in the Coronary and peripheral stents arm will receive Coronary and peripheral stents | Device | Coronary and peripheral stents |
| Pacing cathetersThe participants in the Pacing catheters arm will receive Pacing catheters | Device | Pacing catheters |
| Vascular plugsThe participants in the Vascular plugs arm will receive Vascular plugs | Device | Vascular plugs |
| Measurement and imaging (FFR and OCT)The participants in the Measurement and imaging (FFR and OCT) arm will receive Measurement and imaging (FFR and OCT) | Device | Measurement and imaging (FFR and OCT) |
| Peripheral dilatation cathetersThe participants in the Peripheral dilatation catheters will receive Peripheral dilatation catheters | Device | Peripheral dilatation catheters |
| Coronary dilatation cathetersThe participants in the Coronary dilatation catheters will receive Coronary dilatation catheters | Device | Coronary dilatation catheters |
| Coronary and peripheral guidewiresThe participants in the Coronary and peripheral guidewires will receive Coronary and peripheral guidewires | Device | Coronary and peripheral guidewires |
| Vessel closure/compression devicesThe participants in the Vessel closure/compression devices will receive Vessel closure/compression devices | Device | Vessel closure/compression devices |
| Vascular access introducersThe participants in the Vascular access introducers arm will receive Vascular access introducers | Device | Vascular access introducers |
Primary outcome
Coronary Stents - Number of participants with composite of all-cause death, MI or target lesion revascularization (TLR)
Time frame: During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Composite of all-cause death, MI or target lesion revascularization (TLR) will be assessed among the patients who receive Coronary Stents.
Coronary Stents - Number of participants with composite of all-cause death, MI or target lesion revascularization (TLR)
Time frame: 30 days
Composite of all-cause death, MI or target lesion revascularization (TLR) will be assessed among the patients who receive Coronary Stents.
Coronary Stents - Number of participants with composite of all-cause death, MI or target lesion revascularization (TLR)
Time frame: 12 months
Composite of all-cause death, MI or target lesion revascularization (TLR) will be assessed among the patients who receive Coronary Stents.
Peripheral Stents - Number of participants with composite of all-cause death, amputation, and TLR
Time frame: During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Composite of all-cause death, amputation, and TLR will be assessed among the patients who receive Peripheral Stents.
Peripheral Stents - Number of participants with composite of all-cause death, amputation, and TLR
Time frame: 30 days
Composite of all-cause death, amputation, and TLR will be assessed among the patients who receive Peripheral Stents.
Peripheral Stents - Number of participants with composite of all-cause death, amputation, and TLR
Time frame: 12 months
Composite of all-cause death, amputation, and TLR will be assessed among the patients who receive Peripheral Stents.
Peripheral Stents (Renal Indication) - Number of participants with composite of all-cause death, ipsilateral nephrectomy, Embolic events resulting in kidney damage or TLR
Time frame: During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Composite of all-cause death, ipsilateral nephrectomy, Embolic events resulting in kidney damage or TLR will be assessed among the patients who receive Peripheral Stents (Renal Indication).
Peripheral Stents (Renal Indication) - Number of participants with composite of all-cause death, ipsilateral nephrectomy, Embolic events resulting in kidney damage or TLR
Time frame: 30 days
Composite of all-cause death, ipsilateral nephrectomy, Embolic events resulting in kidney damage or TLR will be assessed among the patients who receive Peripheral Stents (Renal Indication).
Peripheral Stents (Renal Indication) - Number of participants with composite of TLR
Time frame: 12 months
Composite of TLR will be assessed among the patients who receive Peripheral Stents (Renal Indication).
Pacing Catheters - Number of participants with composite of potential complications (venous thrombosis, pulmonary emboli, arrhythmias, perforation)
Time frame: During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Composite of potential complications (venous thrombosis, pulmonary emboli, arrhythmias, perforation) will be assessed among the patients who receive Pacing Catheters.
Pacing Catheters - Loss of capture (assessed based on physiological parameter-ECG)
Time frame: During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Loss of capture (average time of loss of capture across patients) will be assessed among the patients who receive Pacing Catheters. ECG is used to measure whether the pacing device stimulates the heart. Absence of a stimulation is considered a loss of capture.
Vascular Plugs - Number of participants with composite of potential complications (Implant success, occlusion success, migration)
Time frame: During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Composite of potential complications including implant success, occlusion success, migration will be assessed among the patients who receive Vascular Plugs.
Vascular Plugs - Number of participants with composite of occlusion success and migration
Time frame: 30 days
Composite of occlusion success and migration will be assessed among the patients who receive Vascular Plugs.
Fractional flow reserve - Number of participants with composite of vessel dissection, perforation, and thromboembolism
Time frame: During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Composite of vessel dissection, perforation, and thromboembolism during procedure will be assessed among the patients who receive Fractional flow reserve (FFR).
Fractional flow reserve - Number of participants with signal drift (Signal drift between measurements (Pd/Pa** pressure drift >0.03; <0.97 or >1.03)
Time frame: During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Signal drift (Signal drift between measurements (Pd/Pa** pressure drift >0.03; <0.97 or >1.03) will be assessed among the patients who receive FFR.
Optical Coherence Tomography Products - Number of participants with Intraprocedural complications (number of dissections ≥type B, slow flow or no reflow, thrombus, abrupt closure, perforation)
Time frame: During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Intraprocedural complications will be assessed among the patients who receive Optical Coherence Tomography (OCT).
Optical Coherence Tomography Products - Number of participants with Successful crossing and image quality pre-PCI
Time frame: During procedure - Before the stent is implanted (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Successful crossing and image quality pre- PCI will be assessed among the patients who receive OCT.
Optical Coherence Tomography Products - Number of participants with Successful crossing and image quality post-PCI
Time frame: During procedure - Between 10-30 minutes post-PCI (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Successful crossing and image quality post-PCI will be assessed among the patients who receive OCT.
Peripheral Dilatation Catheters - Number of participants with Composite of major adverse events
Time frame: During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Composite of major adverse events (e.g., distal embolization, dissection, perforation, amputation primary to balloon usage, total occlusion, abrupt closure, renal failure primary to balloon usage will be assessed among the patients who receive Peripheral Dilatation Catheters.
Peripheral Dilatation Catheters - Number of participants with Device success (Successful delivery, Successful inflation, Successful deflation, Successful withdrawal) (assessed based on physiological parameters)
Time frame: During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Device success (Successful delivery, Successful inflation, Successful deflation, Successful withdrawal) will be assessed among the patients who receive Peripheral Dilatation Catheters. Device success can be summarized as the successful treatment with the device.
Coronary Guidewires - Number of participants with Composite of major adverse events
Time frame: During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Composite of major adverse events (e.g., vessel perforation, dissection, occlusion, embolism) will be assessed among the patients who receive Coronary Guidewires.
Coronary Guidewires - Number of participants with Device success (Successfully placed, Successfully introduce/position diagnostic/interventional device, Successfully reach/cross target lesion) (assessed based on physiological parameters)
Time frame: During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Device success (Successfully placed, Successfully introduce/position diagnostic/interventional device, Successfully reach/cross target lesion will be assessed among the patients who receive Coronary Guidewires. Device success can be summarized as the successful treatment with the device.
Peripheral Guidewires - Number of participants with Composite of major adverse events
Time frame: During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Composite of major adverse events (e.g., vessel perforation, dissection, occlusion, embolism) will be assessed among the patients who receive Peripheral Guidewires.
Peripheral Guidewires - Number of participants with Device success (Successfully placed, Successfully introduce/position diagnostic/interventional device, Successfully reach/cross target lesion) (assessed based on physiological parameters)
Time frame: During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Device success (Successfully placed, Successfully introduce/position diagnostic/interventional device, Successfully reach/cross target lesion will be assessed among the patients who receive Peripheral Guidewires. Device success can be summarized as the successful treatment with the device.
Coronary Dilatation Catheters - Number of participants with Composite of major adverse events
Time frame: During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Composite of major adverse events (e.g., distal embolization, dissection, perforation, amputation primary to balloon usage, total occlusion, abrupt closure, renal failure primary to balloon usage will be assessed among the patients who receive Coronary Dilatation Catheters.
Coronary Dilatation Catheters - Number of participants with Device success (Successful delivery, Successful inflation, Successful deflation, Successful withdrawal) (assessed based on physiological parameters)
Time frame: During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Device success (Successful delivery, Successful inflation, Successful deflation, Successful withdrawal) will be assessed among the patients who receive Coronary Dilatation Catheters. Device success can be summarized as the successful treatment with the device.
Vessel Closure Devices - Number of participants with Composite of access complications
Time frame: During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Composite of access complications (e.g., hematoma, stenosis/occlusion, infection, access site bleeding) will be assessed among the patients who receive Vessel Closure Devices.
Vessel Closure Devices - Number of participants with Successful hemostasis Major and minor bleeding
Time frame: During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Successful hemostasis Major and minor bleeding will be assessed among the patients who receive Vessel Closure Devices.
Vessel Compression Devices - Number of participants with Major and minor bleeding
Time frame: During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Major and minor bleeding will be assessed among the patients who receive Vessel Compression Devices.
Vessel Compression Devices - Number of participants with Complications including: pseudoaneurysm, hematoma (>5cm) in diameter, Hb drop>20 g/L, extended compression time >6 hours, blood transfusion required, bleeding requiring surgical procedure
Time frame: During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Complications including: pseudoaneurysm requiring treatment, hematoma (>5cm) in diameter, Hb drop>20 g/L, extended compression time >6 hours, blood transfusion required, bleeding requiring surgical procedure will be assessed among the patients who receive Vessel Compression Devices.
Vascular Access Introducers - Incidence of safety issues
Time frame: During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Incidence of safety issues (e.g., bleeding, air embolism, hematoma, vessel damage (dissection, perforation, pseudoaneurysm), infection, thrombosis, AV fistula, occlusion, radial artery spasm) will be assessed among the patients who receive Vascular Access Introducers.
Vascular Access Introducers - Incidence of performance issues
Time frame: During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Incidence of performance issues (e.g., unable to introduce other devices, failure to maintain hemostasis valve integrity, air leakage, bending or kinking of introducer, difficulty inserting/removing the sheath, device breakage detachment or separation, issue with an associated accessory) will be assessed among the patients who receive Vascular Access Introducers.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Acute Myocardial Infarction
RecruitingObservational study
Changes in Skeletal Muscle Thickness in Patients With Acute Heart Failure
Heart Failure, Muscle Atrophy
Recruiting
Routine Versus Provisional Distal Perfusion Catheter Placement in Patients Undergoing Mechanical Circulatory Support
Cardiogenic Shock, Acute Myocardial Infarction of Inferior Wall
Recruiting
Ezetimibe Utilization Early After Acute Myocardial Infarction, "EzAMI Trial"
Acute Myocardial Infarction, Dyslipidemias
Not yet recruitingObservational study
iLITE, Clinical Performance of the Angiolite™ Drug-Eluting Stent
PCI Patients, de Novo Coronary Lesions
Active, not recruiting
Point-of-Care Troponin Testing in the Emergency Department
Acute Coronary Syndromes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chinedu Agbonghai, MS contact
Chananit Hutson, PhD study director
Abbott Medical Devices
37 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocardial Infarction and Restenoses, Coronary, run by Abbott Medical Devices at 37 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States, Germany, Taiwan, China, Italy and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sharan Dhanjal, MPH (+1 714-926-8292, sharanjeet.dhanjal@abbott.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coronary Stents - Number of participants with composite of all-cause death, MI or target lesion revascularization (TLR) (time frame: During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)). The study lists 32 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.