Coronary DiseaseABSORB UKNCT01977534
To Study the Safety and Clinical Outcomes of the Absorb Bioresorbable Vascular Scaffold (BVS) System in Patients With de Novo Lesions in Previously Untreated Vessels
An observational study of Coronary Disease and Coronary Artery Disease, run by Abbott Medical Devices at 24 sites in United Kingdom.
Trial summary
The purpose of this study is to determine the safety and clinical outcomes of the Absorb BVS for daily use in patients with de novo lesions in previously untreated vessels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Disease, Coronary Artery Disease, Coronary Restenosis
- What is being tested?
- Absorb BVS
- Type of treatment
- Medical device
- How many people
- 1,005 participants
- Where
- 24 sitesUnited Kingdom
- Study dates
- Jan 2014to Oct 2018
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 will be selected from the general interventional cardiology population
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
24 sites in 1 country.
24 sites in 1 country
United Kingdom24 sites
Basildon Hospital
Basildon
Royal Victoria Hospital
Belfast
Glan Clwyd District General Hospital
Bodelwyddan
Royal Bournmouth Hospital
Bournemouth
Sussex Cardiac Centre
Brighton
Bristol Heart Institute
Bristol
Papworth Hospital
Cambridge
Royal Infirmary of Edinburgh
Edinburgh
Frimley Park Hospital
Frimley
Golden Jubilee National Hospital
Glasgow
Leeds General Infirmary
Leeds
Glenfield Hospital
Leicester
Barts Heart Centre
London
Kings College Hospital
London
Northwick Park Hospital
London
Royal Brompton Hospital
London
Manchester Royal Infirmary
Manchester
James Cook University Hospital
Middlesbrough
The Freeman Hospital
Newcastle
Norfolk & Norwich University Hospital
Norwich
John Radcliffe Hospital
Oxford
Queen Alexandra Hospital
Portsmouth
Southampton General Hospital
Southampton
Lister Hospital
Stevenage, Hertfordshire
About this study
Official title: A Post-market Registry of Patients With de Novo Lesions in Previously Untreated Vessels Treated With Absorb BVS
The purpose of this study is to determine the safety and clinical outcomes of the Absorb BVS for daily use in patients with de novo lesions in previously untreated vessels.
Read the detailed description
ABSORB UK registry is a prospective, single arm, post-market registry designed to:
- Provide ongoing post-market surveillance for documentation of safety and clinical outcomes of the Absorb Everolimus Eluting BVS System in daily percutaneous coronary intervention (PCI) practice per Instructions for Use (IFU, on-label use).
- 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.
- Being tested
- Absorb BVS
- Keywords
- Bioabsorbable, Coronary Stent, Everolimus, drug eluting stents, stents, angioplasty, coronary artery disease, total coronary occlusion, coronary artery restenosis, stent thrombosis, vascular disease, myocardial ischemia, coronary artery stenosis, CAD, CAOD
- Medical subject headings
- Coronary Disease, Coronary Artery Disease, Coronary Restenosis, Vascular Diseases, Myocardial Ischemia, Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Absorb BVSDevice
The Absorb BVS System is a bioresorbable poly(L-lactide) (PLLA) scaffold with a drug and bioresorbable polymer coating [formulation of everolimus in a bioresorbable poly(D,L-lactide) (PDLLA) coating].
| Study group | Role | What they receive |
|---|---|---|
| Absorb BVS | Subjects receiving Absorb BVS Receives: Device: Absorb BVS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Success: Device success (lesion based analysis)
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 is considered to have failed if it did not meet the requirements of the definition for clinical device success.
Measured: From the start of index procedure to end of index procedure
Acute Success: Procedural success (patient based analysis)
Achievement of a final in-scaffold diameter stenosis of < 50% by online 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: From the start of index procedure to end of index procedure
Death (Cardiovascular, Non-Cardiovascular)
Measured: 1 year
Death (Cardiovascular, Non-Cardiovascular)
Measured: 3 year
Myocardial Infarction (MI)
Attributable to Q-wave MI (QMI), non-Q wave MI (NQMI), target vessel (TV), non-target vessel (NTV)
Measured: 1 year
MI
Attributable to Q-wave MI (QMI), non-Q wave MI (NQMI), target vessel (TV), non-target vessel (NTV)
Measured: 3 year
Target Lesion Revascularization (TLR)
all TLR
Measured: 1 year
TLR
all TLR
Measured: 3 year
TLR
clinically indicated (ID-TLR)
Measured: 1 year
TLR
ID-TLR
Measured: 3 year
Target Vessel Revascularization (TVR)
all TVR
Measured: 1 year
TVR
all TVR
Measured: 3 year
TVR
clinically indicated (ID-TVR)
Measured: 1 year
TVR
ID-TVR
Measured: 3 year
Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) (Device-oriented endpoint)
Measured: 1 year
Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) (Device-oriented endpoint)
Measured: 3 year
Cardiac Death/All MI/ID-TLR (MACE)
Measured: 1 year
Cardiac Death/All MI/ID-TLR (MACE)
Measured: 3 year
Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF))
Measured: 1 year
Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF))
Measured: 3 year
Scaffold/Stent Thrombosis
acute, sub-acute, late and very late
Measured: 1 year
Scaffold/Stent Thrombosis
Definite, Probable
Measured: 1 year
Scaffold/Stent Thrombosis
acute, sub-acute, late and very late
Measured: 3 year
Scaffold/Stent Thrombosis
Definite, Probable
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2013 (estimated)
- Study startJan 2014
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary DiseaseStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,005 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andreas Baumbach, Principal investigator, Bristol Heart InstituteSusan Veldhof, Study director, Clinical Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01977534
- Sponsor's protocol ID
- 13-304
- Acronym
- ABSORB UK
- Status last verified
- Dec 2018
- First submitted
- 18 Oct 2013
- Last updated
- 17 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Baumbach A, Zaman A, West NEJ, O'Kane P, Egred M, Johnson T, Wheatcroft S, Bowles R, de Belder A, Bouras G, Lansky A, Hill J, Mathur A, de Belder MA, Banning AP. Acute and one-year clinical outcomes following implantation of bioresorbable vascular scaffolds: the ABSORB UK Registry. EuroIntervention. 2018 Jan 20;13(13):1554-1560. doi: 10.4244/EIJ-D-17-00886.
PubMed 29131802
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-market Registry of Patients With de Novo Lesions in Previously Untreated Vessels Treated With Absorb BVS
- ClinicalTrials.gov ID
- NCT01977534
- Acronym / sponsor ID
- ABSORB UK / 13-304
- Keywords
- Bioabsorbable, Coronary Stent, Everolimus, drug eluting stents, stents, angioplasty, coronary artery disease, total coronary occlusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,005 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 6 Nov 2013 (estimated)
- 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 purpose of this study is to determine the safety and clinical outcomes of the Absorb BVS for daily use in patients with de novo lesions in previously untreated vessels.
Detailed description
ABSORB UK registry is a prospective, single arm, post-market registry designed to:
- Provide ongoing post-market surveillance for documentation of safety and clinical outcomes of the Absorb Everolimus Eluting BVS System in daily percutaneous coronary intervention (PCI) practice per Instructions for Use (IFU, on-label use).
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Absorb BVS | – | Device: Absorb BVSSubjects receiving Absorb BVS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be selected from the general interventional cardiology population
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
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 BVSThe Absorb BVS System is a bioresorbable poly(L-lactide) (PLLA) scaffold with a drug and bioresorbable polymer coating [formulation of everolimus in a bioresorbable poly(D,L-lactide) (PDLLA) coating]. | Device | Absorb BVS |
Primary outcome
Acute Success: Device success (lesion based analysis)
Time frame: From the start of index procedure to end of index procedure
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 is considered to have failed if it did not meet the requirements of the definition for clinical device success.
Acute Success: Procedural success (patient based analysis)
Time frame: From the start of index procedure to end of index procedure
Achievement of a final in-scaffold diameter stenosis of < 50% by online 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.
Death (Cardiovascular, Non-Cardiovascular)
Time frame: 1 year
Death (Cardiovascular, Non-Cardiovascular)
Time frame: 3 year
Myocardial Infarction (MI)
Time frame: 1 year
Attributable to Q-wave MI (QMI), non-Q wave MI (NQMI), target vessel (TV), non-target vessel (NTV)
MI
Time frame: 3 year
Attributable to Q-wave MI (QMI), non-Q wave MI (NQMI), target vessel (TV), non-target vessel (NTV)
Target Lesion Revascularization (TLR)
Time frame: 1 year
all TLR
TLR
Time frame: 3 year
all TLR
TLR
Time frame: 1 year
clinically indicated (ID-TLR)
TLR
Time frame: 3 year
ID-TLR
Target Vessel Revascularization (TVR)
Time frame: 1 year
all TVR
TVR
Time frame: 3 year
all TVR
TVR
Time frame: 1 year
clinically indicated (ID-TVR)
TVR
Time frame: 3 year
ID-TVR
Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) (Device-oriented endpoint)
Time frame: 1 year
Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) (Device-oriented endpoint)
Time frame: 3 year
Cardiac Death/All MI/ID-TLR (MACE)
Time frame: 1 year
Cardiac Death/All MI/ID-TLR (MACE)
Time frame: 3 year
Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF))
Time frame: 1 year
Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF))
Time frame: 3 year
Scaffold/Stent Thrombosis
Time frame: 1 year
acute, sub-acute, late and very late
Scaffold/Stent Thrombosis
Time frame: 1 year
Definite, Probable
Scaffold/Stent Thrombosis
Time frame: 3 year
acute, sub-acute, late and very late
Scaffold/Stent Thrombosis
Time frame: 3 year
Definite, Probable
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2018.
- Derived from this study: PubMed 29131802Baumbach A, Zaman A, West NEJ, O'Kane P, Egred M, Johnson T, Wheatcroft S, Bowles R, de Belder A, Bouras G, Lansky A, Hill J, Mathur A, de Belder MA, Banning AP. Acute and one-year clinical outcomes following implantation of bioresorbable vascular scaffolds: the ABSORB UK Registry. EuroIntervention. 2018 Jan 20;13(13):1554-1560. doi: 10.4244/EIJ-D-17-00886.
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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.
Andreas Baumbach principal investigator
Bristol Heart Institute
Susan Veldhof study director
Clinical Science
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Disease and Coronary Artery Disease, run by Abbott Medical Devices at 24 sites in United Kingdom.
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 17 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Acute Success: Device success (lesion based analysis) (time frame: From the start of index procedure to end of index procedure). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01977534, which also lists 1 linked publication.
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 17 Dec 2018.