Chronic Total Occlusion of Coronary ArteryNCT01759290
ABSORB FIRST is a Registry Designed to Evaluate the Safety and Performance of Absorb Bioresorbable Vascular Scaffold (Absorb BVS) Used in Real-world Patients.
An observational study of Chronic Total Occlusion of Coronary Artery and Coronary Occlusion, run by Abbott Medical Devices at 1 site in Belgium.
Trial summary
ABSORB FIRST is a prospective, multi-center registry. The objectives of the study are to: Provide ongoing post-market surveillance for documentation of safety, performance and clinical outcomes of the Absorb BVS (Bioresorbable Vascular Scaffold) System in daily percutaneous coronary intervention (PCI) practice per… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Total Occlusion of Coronary Artery, Coronary Occlusion, Coronary Artery Disease
- What is being tested?
- Absorb Bioresorbable Vascular Scaffold
- Type of treatment
- Medical device
- How many people
- 1,800 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2013to Dec 2015
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Patients enrolled into this registry will be male and female patients derived from the general interventional cardiology population who satisfy the inclusion and exclusion criteria.
Who may be able to join
- The inclusion criteria must follow the most recent IFU which may include but are not limited to the following:
- Patient must be at least 18 years of age at the time of signing the Informed Consent Form
- Patient is to be treated for de novo lesions located in previously untreated vessels.
- Patient must agree to undergo all required follow-up visits and data collection.
Who cannot join
- The exclusion criteria must follow the most recent IFU which may include but are not limited to the following:
- Inability to obtain a signed informed consent from potential patient.
- Patient belongs to a vulnerable population (per investigator's judgment, this also includes people with a direct link (hierarchical or financial benefit) to the registry Doctor or the registry Sponsor).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ABSORB FIRST Registry: An International Post-market Registry of Patients With de Novo Lesions in Previously Untreated Vessels Treated With Absorb Bioresorbable Vascular Scaffold (Absorb BVS).
ABSORB FIRST is a prospective, multi-center registry. The objectives of the study are to:
- Provide ongoing post-market surveillance for documentation of safety, performance and clinical outcomes of the Absorb BVS (Bioresorbable Vascular Scaffold) System in daily percutaneous coronary intervention (PCI) practice per Instructions for Use (IFU, on-label use).
- To evaluate the safety and performance of 12 mm or shorter Absorb BVS in single or overlapping use (bailout, optimization of long lesion treatment) for the treatment of patients with ischemic heart disease caused by de novo native coronary artery lesion(s)
- Collect additional information (e.g. acute success) to evaluate handling and implantation of Absorb BVS by physicians under a wide range of commercial use conditions and following routine clinical practice.
Read the detailed description
the ABSORB FIRST Registry is intended to provide an assessment of the safety and performance of the Absorb BVS device in accordance to the IFU in real world use involving more complex patients, lesions and use (examples: longer lesions, overlapping use, bailout, patients at high risks for cardiac events, etc.).
The ABSORB FIRST study will register a minimum of 1800 patients in approximately 90 sites throughout multiple countries worldwide where Absorb BVS has regulatory approval or is commercially available.
- Conditions
- Chronic Total Occlusion of Coronary Artery, Coronary Occlusion, Coronary Artery Disease, Coronary Artery Restenosis, Coronary Artery Stenosis, Coronary Disease
- Being tested
- Absorb Bioresorbable Vascular Scaffold
- Keywords
- Angioplasty, Bioabsorbable, Bioresorbable, BVS, Coronary Artery Endothelial Responsiveness, Coronary Scaffold, Coronary Stent
- Medical subject headings
- Coronary Occlusion, Coronary Artery Disease, Coronary Restenosis, Coronary Stenosis, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Absorb Bioresorbable Vascular ScaffoldDevice
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
| Study group | Role | What they receive |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | Subjects receiving the Absorb Bioresorbable Vascular Scaffold Receives: Device: Absorb Bioresorbable Vascular Scaffold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))
Target Lesion Failure includes Cardiac Death,Target Vessel-Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
Measured: 0 to 407 days
Secondary outcomes (56)
Acute Success: Clinical Device Success (Lesion Level Analysis)
Device success was defined as the achievement of a final in-scaffold residual diameter stenosis of <50% assessed by online quantitative angiography or visual estimation, using Absorb BVS and without a device deficiency. A device was considered to have failed if it did not meet the requirements of the definition for clinical device success.
Measured: < or = 1 day
Acute Success: Clinical Procedure Success (Per Subject Analysis)
Procedure success was defined as the achievement of a final in-scaffold diameter stenosis of <50% by online quantitative coronary angiography (QCA) or visual estimation using Absorb BVS, with or without any adjunctive devices, and without the occurrence of cardiac death, target vessel MI (Q-wave and non-Q-wave MI), or repeat revascularization of the target lesion within 3 days of the index procedure.
Measured: During the hospital stay with a maximum of 3 days post index procedure
Acute Scaffold Thrombosis
Measured: <1 day
Subacute ScaffoldThrombosis
Measured: 1 to 30 days
Late Scaffold Thrombosis
Measured: 31 to 365 Days
All Death, All MI, All Revascularization (DMR)
Measured: 0 to 7 days (In-hospital)
Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)
Target Vessel Failure (TVF) includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Vessel Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
Measured: 0 to 7 days (In-hospital)
Major Adverse Cardiac Event (MACE)
MACE includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
Measured: 0 to 7 days (In-hospital)
Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))
Target Lesion Failure includes Cardiac Death,Target Vessel-Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
Measured: 0 to 7 days (In-hospital)
Cardiac Death/All MI
Measured: 0 to 7 days (In-hospital)
All Death/All MI
Measured: 0 to 7 days (In-hospital)
All Death, All MI, All Revascularization (DMR)
Measured: 0 to 37 days
Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)
Target Vessel Failure (TVF) includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Vessel Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
Measured: 0 to 37 days
Major Adverse Cardiac Event (MACE)
MACE includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
Measured: 0 - 37 Days
Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))
Target Lesion Failure includes Cardiac Death,Target Vessel-Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
Measured: 0 to 37 Days
Cardiac Death/All MI
Measured: 0 to 37 days
All Death/All MI
Measured: 0 to 37 days
All Death, All MI, All Revascularization (DMR)
Measured: 0 to 180 days
Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)
Target Vessel Failure (TVF) includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Vessel Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
Measured: 0 to 180 days
Major Adverse Cardiac Event (MACE)
MACE includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
Measured: 0 to 180 Days
Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))
Target Lesion Failure includes Cardiac Death,Target Vessel-Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
Measured: 0 to 180 Days
Cardiac Death/All MI
Measured: 0 to 180 days
All Death/All MI
Measured: 0 to 180 days
All Death, All MI, All Revascularization (DMR)
Measured: 0 to 407 days
Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)
Target Vessel Failure (TVF) includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Vessel Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
Measured: 0 to 407 days
Major Adverse Cardiac Event (MACE)
MACE includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
Measured: 0 to 407 Days
Cardiac Death/All MI
Measured: 0 to 407 days
All Death/All MI
Measured: 0 to 407 days
Death (Cardiovascular, Non-Cardiovascular)
This is one of the Safety Component (non-hierarchical) endpoints.
Measured: 0 to 7 days (In-hospital)
All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).
This is one of the Safety Component (non-hierarchical) endpoints.
Measured: 0 to 7 days (In-hospital)
Target Lesion Revascularization (TLR): All TLR
This is one of the Efficacy Component (non-hierarchical) endpoints.
Measured: 0 to 7 days (In-hospital)
Target Lesion Revascularization : Ischemia-Driven (ID-TLR)
This is one of the Efficacy Component (non-hierarchical) endpoints.
Measured: 0 to 7 days (In-hospital)
Target Vessel Revascularization (TVR): All TVR
This is one of the Efficacy Component (non-hierarchical) endpoints.
Measured: 0 to 7 days (In-hospital)
Target Vessel Revascularization : Ischemic-driven (ID-TVR)
This is one of the Efficacy Component (non-hierarchical) endpoints.
Measured: 0 to 7 days (In-hospital)
All Revascularization
This is one of the Efficacy Component (non-hierarchical) endpoints.
Measured: 0 to 7 days (In-hospital)
Death (Cardiovascular, Non-Cardiovascular)
This is one of the Safety Component (non-hierarchical) endpoints.
Measured: 0 to 37 days
All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).
This is one of the Safety Component (non-hierarchical) endpoints.
Measured: 0 to 37 days
Target Lesion Revascularization (TLR): All TLR
This is one of the Efficacy Component (non-hierarchical) endpoints.
Measured: 0 to 37 days
Target Lesion Revascularization : Ischemia-Driven (ID-TLR)
This is one of the Efficacy Component (non-hierarchical) endpoints.
Measured: 0 to 37 days
Target Vessel Revascularization (TVR): All TVR
This is one of the Efficacy Component (non-hierarchical) endpoints.
Measured: 0 to 37 days
Target Vessel Revascularization : Ischemic-driven (ID-TVR)
This is one of the Efficacy Component (non-hierarchical) endpoints.
Measured: 0 to 37 days
All Revascularization
This is one of the Efficacy Component (non-hierarchical) endpoints.
Measured: 0 to 37 days
Death (Cardiovascular, Non-Cardiovascular)
This is one of the Safety Component (non-hierarchical) endpoints.
Measured: 0 to 180 days
All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).
This is one of the Safety Component (non-hierarchical) endpoints.
Measured: 0 to 180 days
Target Lesion Revascularization (TLR): All TLR
This is one of the Efficacy Component (non-hierarchical) endpoints.
Measured: 0 to 180 days
Target Lesion Revascularization : Ischemia-Driven (ID-TLR)
This is one of the Efficacy Component (non-hierarchical) endpoints.
Measured: 0 to 180 days
Target Vessel Revascularization (TVR): All TVR
This is one of the Efficacy Component (non-hierarchical) endpoints.
Measured: 0 to 180 days
Target Vessel Revascularization : Ischemic-driven (ID-TVR)
This is one of the Efficacy Component (non-hierarchical) endpoints.
Measured: 0 to 180 days
All Revascularization
This is one of the Efficacy Component (non-hierarchical) endpoints.
Measured: 0 to 180 days
Death (Cardiovascular, Non-Cardiovascular)
This is one of the Safety Component (non-hierarchical) endpoints.
Measured: 0 to 407 days
All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).
This is one of the Safety Component (non-hierarchical) endpoints.
Measured: 0 to 407 days
Target Lesion Revascularization (TLR): All TLR
This is one of the Efficacy Component (non-hierarchical) endpoints.
Measured: 0 to 407 days
Target Lesion Revascularization : Ischemia-Driven (ID-TLR)
This is one of the Efficacy Component (non-hierarchical) endpoints.
Measured: 0 to 407 days
Target Vessel Revascularization (TVR): All TVR
This is one of the Efficacy Component (non-hierarchical) endpoints.
Measured: 0 to 407 days
Target Vessel Revascularization : Ischemic-driven (ID-TVR)
This is one of the Efficacy Component (non-hierarchical) endpoints.
Measured: 0 to 407 days
All Revascularization
This is one of the Efficacy Component (non-hierarchical) endpoints.
Measured: 0 to 407 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionAug 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Total Occlusion of Coronary ArteryStudies 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
- 1,800 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ashok Seth, MD, Principal investigator, Fortis Escorts Heart Institute, New DelhiEric Eeckhout, MD, PhD, Principal investigator, Centre Hospitalier Universitaire VaudoisPeter Staehr, MD, Study director, Abbott Medical DevicesVivian Mao, MD, MPH, Study director, Clinical Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01759290
- Sponsor's protocol ID
- 12-302
- Status last verified
- Aug 2016
- First submitted
- 14 Dec 2012
- Last updated
- 19 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ABSORB FIRST Registry: An International Post-market Registry of Patients With de Novo Lesions in Previously Untreated Vessels Treated With Absorb Bioresorbable Vascular Scaffold (Absorb BVS).
- ClinicalTrials.gov ID
- NCT01759290
- Acronym / sponsor ID
- 12-302
- Conditions
- Chronic Total Occlusion of Coronary Artery, Coronary Occlusion, Coronary Artery Disease, Coronary Artery Restenosis, Coronary Artery Stenosis, Coronary Disease
- Keywords
- Angioplasty, Bioabsorbable, Bioresorbable, BVS, Coronary Artery Endothelial Responsiveness, Coronary Scaffold, Coronary Stent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,800 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 3 Jan 2013 (estimated)
- Results
- Posted 19 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
ABSORB FIRST is a prospective, multi-center registry. The objectives of the study are to:
- Provide ongoing post-market surveillance for documentation of safety, performance and clinical outcomes of the Absorb BVS (Bioresorbable Vascular Scaffold) System in daily percutaneous coronary intervention (PCI) practice per Instructions for Use (IFU, on-label use).
- To evaluate the safety and performance of 12 mm or shorter Absorb BVS in single or overlapping use (bailout, optimization of long lesion treatment) for the treatment of patients with ischemic heart disease caused by de novo native coronary artery lesion(s)
- Collect additional information (e.g. acute success) to evaluate handling and implantation of Absorb BVS by physicians under a wide range of commercial use conditions and following routine clinical practice.
Detailed description
the ABSORB FIRST Registry is intended to provide an assessment of the safety and performance of the Absorb BVS device in accordance to the IFU in real world use involving more complex patients, lesions and use (examples: longer lesions, overlapping use, bailout, patients at high risks for cardiac events, etc.).
The ABSORB FIRST study will register a minimum of 1800 patients in approximately 90 sites throughout multiple countries worldwide where Absorb BVS has regulatory approval or is commercially available.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Absorb Bioresorbable Vascular Scaffold | – | Device: Absorb Bioresorbable Vascular ScaffoldSubjects receiving the Absorb Bioresorbable Vascular Scaffold |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients enrolled into this registry will be male and female patients derived from the general interventional cardiology population who satisfy the inclusion and exclusion criteria.
Key inclusion criteria (4 listed)
- The inclusion criteria must follow the most recent IFU which may include but are not limited to the following:
Key exclusion criteria (3 listed)
- The exclusion criteria must follow the most recent IFU which may include but are not limited to the following:
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 |
|---|---|---|
| Absorb Bioresorbable Vascular ScaffoldSubjects receiving the Absorb Bioresorbable Vascular Scaffold | Device | Absorb Bioresorbable Vascular Scaffold |
Primary outcome
Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))
Time frame: 0 to 407 days
Target Lesion Failure includes Cardiac Death,Target Vessel-Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
56 secondary outcomes
Acute Success: Clinical Device Success (Lesion Level Analysis)
Time frame: < or = 1 day
Acute Success: Clinical Procedure Success (Per Subject Analysis)
Time frame: During the hospital stay with a maximum of 3 days post index procedure
Acute Scaffold Thrombosis
Time frame: <1 day
Subacute ScaffoldThrombosis
Time frame: 1 to 30 days
Late Scaffold Thrombosis
Time frame: 31 to 365 Days
All Death, All MI, All Revascularization (DMR)
Time frame: 0 to 7 days (In-hospital)
Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)
Time frame: 0 to 7 days (In-hospital)
Major Adverse Cardiac Event (MACE)
Time frame: 0 to 7 days (In-hospital)
Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))
Time frame: 0 to 7 days (In-hospital)
Cardiac Death/All MI
Time frame: 0 to 7 days (In-hospital)
All Death/All MI
Time frame: 0 to 7 days (In-hospital)
All Death, All MI, All Revascularization (DMR)
Time frame: 0 to 37 days
Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)
Time frame: 0 to 37 days
Major Adverse Cardiac Event (MACE)
Time frame: 0 - 37 Days
Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))
Time frame: 0 to 37 Days
Cardiac Death/All MI
Time frame: 0 to 37 days
All Death/All MI
Time frame: 0 to 37 days
All Death, All MI, All Revascularization (DMR)
Time frame: 0 to 180 days
Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)
Time frame: 0 to 180 days
Major Adverse Cardiac Event (MACE)
Time frame: 0 to 180 Days
Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))
Time frame: 0 to 180 Days
Cardiac Death/All MI
Time frame: 0 to 180 days
All Death/All MI
Time frame: 0 to 180 days
All Death, All MI, All Revascularization (DMR)
Time frame: 0 to 407 days
Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)
Time frame: 0 to 407 days
Major Adverse Cardiac Event (MACE)
Time frame: 0 to 407 Days
Cardiac Death/All MI
Time frame: 0 to 407 days
All Death/All MI
Time frame: 0 to 407 days
Death (Cardiovascular, Non-Cardiovascular)
Time frame: 0 to 7 days (In-hospital)
All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).
Time frame: 0 to 7 days (In-hospital)
Target Lesion Revascularization (TLR): All TLR
Time frame: 0 to 7 days (In-hospital)
Target Lesion Revascularization : Ischemia-Driven (ID-TLR)
Time frame: 0 to 7 days (In-hospital)
Target Vessel Revascularization (TVR): All TVR
Time frame: 0 to 7 days (In-hospital)
Target Vessel Revascularization : Ischemic-driven (ID-TVR)
Time frame: 0 to 7 days (In-hospital)
All Revascularization
Time frame: 0 to 7 days (In-hospital)
Death (Cardiovascular, Non-Cardiovascular)
Time frame: 0 to 37 days
All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).
Time frame: 0 to 37 days
Target Lesion Revascularization (TLR): All TLR
Time frame: 0 to 37 days
Target Lesion Revascularization : Ischemia-Driven (ID-TLR)
Time frame: 0 to 37 days
Target Vessel Revascularization (TVR): All TVR
Time frame: 0 to 37 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Chronic Total Occlusion of Coronary Artery
Active, not recruiting
To Evaluate Whether IVUS-guided Drug-eluting Stent (DES) Implantation Leads to Better Clinical Outcomes Compared to Conventional Angiography in the Treatment of Chronic Complete Occlusion (CTO) Disease.
Chronic Total Occlusion of Coronary Artery
RecruitingObservational study
Real-World Outcomes of Drug-Coated Balloon Angioplasty in Coronary Artery Disease
Coronary Artery Disease
RecruitingObservational study
Predicting Functional Recovery After Coronary Chronic Total Occlusion Revascularization
Chronic Total Occlusions of Coronary Arteries, Stress Echocardiography (SE)
Not yet recruiting
Drug-Coated Balloon Only Strategy After Recanalization of Chronic Total Coronary Occlusions
Angina (Stable), Coronary Occlusion
RecruitingObservational study
Prospective Global Registry for the Study of Chronic Total Occlusion Intervention
Coronary Artery Disease
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. This study is not recruiting at the moment.
Ashok Seth, MD principal investigator
Fortis Escorts Heart Institute, New Delhi
Eric Eeckhout, MD, PhD principal investigator
Centre Hospitalier Universitaire Vaudois
Peter Staehr, MD study director
Abbott Medical Devices
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Total Occlusion of Coronary Artery and Coronary Occlusion, run by Abbott Medical Devices at 1 site in Belgium.
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 3 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: finished, as of the sponsor's last update on 19 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
Yes. Results are posted in the registry (first posted 19 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) (time frame: 0 to 407 days). 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 19 Oct 2016.