Intracoronary AngioplastyFRANCE-ABSORBNCT02238054
French Observatory Evaluating the Use of Intracoronary Prosthesis ABSORB BVS
An observational study of Intracoronary Angioplasty, run by French Cardiology Society at 1 site in France.
Trial summary
Observational Study, French, prospective, multicenter rated using intravascular prosthesis ABSORB BVS. ABSORB BVS is a prosthesis of a new type. This study will prospectively evaluate all procedures for coronary angioplasty with implantation of at least one BVS with a clinical follow-up of all patients implanted with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracoronary Angioplasty
- How many people
- 2,072 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2014to 30 May 2022
- How long will I take part?
- 5 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: All the departments of Cardiology, from French health institutions, who are authorized to implement, may participate in the observatory. It is estimated that this procedure will be performed by 50 to 60 sites performing the installation of BVS. The list of centers is scalable, their number can be expected to increase.
Who may be able to join
- Patient affiliated to the National Health Insurance Scheme
- Patient able to assess and understand the risks, benefits and alternative treatments laying of ABSORB, to agree to participate in the study (by signing the informed consent after having read the newsletter)
- Patients for whom a procedure is performed coronary angioplasty with implantation of at least one BVS.
- Patient allowing the follow-up as defined in the study
Who cannot join
- Pregnant patient
- Patient that can not give informed consent
- Patient with in-stent restenosis or saphenous vein bypass
Trial locations and contacts
1 site in 1 country.
About this study
Observational Study, French, prospective, multicenter rated using intravascular prosthesis ABSORB BVS.
ABSORB BVS is a prosthesis of a new type. This study will prospectively evaluate all procedures for coronary angioplasty with implantation of at least one BVS with a clinical follow-up of all patients implanted with ABSORB BVS. This national observatory will collect all the events related to product and / or to procedure
- Conditions
- Intracoronary Angioplasty
- Keywords
- Cardiology, Intracoronary angioplasty, Bioresorbable stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ABSORB BVS | All patients with a coronary angioplasty procedure and the implantation of at least one ABSORB BVS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiac Events at 1 year
At 1 year of follow-up, to evaluate the rate of MACE (Major Adverse Cardiac Events) defined as follows:
- Death from cardiac causes
- Myocardial Infarction
- Rates of target lesion revascularization (TLR) of ischemic origin (ID-TLR)
- Surgery unscheduled bypass graft (CABG)
Measured: 1 year
Secondary outcomes (2)
Target vessel revascularization at 1 year
At 1 year of follow-up, to evaluate the rate of target vessel revascularization (TVR)
Measured: 1 year
Rate of stent thrombosis at 1 year
At 1 year of follow-up, to evaluate the rate of stent thrombosis as ARC definitions :
- acute, subacute, late
- probable or undoubted
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2017
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for Intracoronary AngioplastyStudies of the same condition, open and under way.
- 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
- 2,072 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- French Cardiology Society
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02238054
- Sponsor's protocol ID
- 14249
- Acronym
- FRANCE-ABSORB
- Status last verified
- Sep 2022
- First submitted
- 10 Sep 2014
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sigwart U, Puel J, Mirkovitch V, Joffre F, Kappenberger L. Intravascular stents to prevent occlusion and restenosis after transluminal angioplasty. N Engl J Med. 1987 Mar 19;316(12):701-6. doi: 10.1056/NEJM198703193161201.
PubMed 2950322Gruntzig AR, Senning A, Siegenthaler WE. Nonoperative dilatation of coronary-artery stenosis: percutaneous transluminal coronary angioplasty. N Engl J Med. 1979 Jul 12;301(2):61-8. doi: 10.1056/NEJM197907123010201.
PubMed 449946Serruys PW, de Jaegere P, Kiemeneij F, Macaya C, Rutsch W, Heyndrickx G, Emanuelsson H, Marco J, Legrand V, Materne P, et al. A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. Benestent Study Group. N Engl J Med. 1994 Aug 25;331(8):489-95. doi: 10.1056/NEJM199408253310801.
PubMed 8041413Serruys PW, Kutryk MJ, Ong AT. Coronary-artery stents. N Engl J Med. 2006 Feb 2;354(5):483-95. doi: 10.1056/NEJMra051091. No abstract available.
PubMed 16452560Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnar F, Falotico R; RAVEL Study Group. Randomized Study with the Sirolimus-Coated Bx Velocity Balloon-Expandable Stent in the Treatment of Patients with de Novo Native Coronary Artery Lesions. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002 Jun 6;346(23):1773-80. doi: 10.1056/NEJMoa012843.
PubMed 12050336Abbott JD, Voss MR, Nakamura M, Cohen HA, Selzer F, Kip KE, Vlachos HA, Wilensky RL, Williams DO. Unrestricted use of drug-eluting stents compared with bare-metal stents in routine clinical practice: findings from the National Heart, Lung, and Blood Institute Dynamic Registry. J Am Coll Cardiol. 2007 Nov 20;50(21):2029-36. doi: 10.1016/j.jacc.2007.07.071.
PubMed 18021868Ormiston JA, Serruys PW, Regar E, Dudek D, Thuesen L, Webster MW, Onuma Y, Garcia-Garcia HM, McGreevy R, Veldhof S. A bioabsorbable everolimus-eluting coronary stent system for patients with single de-novo coronary artery lesions (ABSORB): a prospective open-label trial. Lancet. 2008 Mar 15;371(9616):899-907. doi: 10.1016/S0140-6736(08)60415-8.
PubMed 18342684Serruys PW, Ormiston JA, Onuma Y, Regar E, Gonzalo N, Garcia-Garcia HM, Nieman K, Bruining N, Dorange C, Miquel-Hebert K, Veldhof S, Webster M, Thuesen L, Dudek D. A bioabsorbable everolimus-eluting coronary stent system (ABSORB): 2-year outcomes and results from multiple imaging methods. Lancet. 2009 Mar 14;373(9667):897-910. doi: 10.1016/S0140-6736(09)60325-1.
PubMed 19286089Serruys PW, Onuma Y, Ormiston JA, de Bruyne B, Regar E, Dudek D, Thuesen L, Smits PC, Chevalier B, McClean D, Koolen J, Windecker S, Whitbourn R, Meredith I, Dorange C, Veldhof S, Miquel-Hebert K, Rapoza R, Garcia-Garcia HM. Evaluation of the second generation of a bioresorbable everolimus drug-eluting vascular scaffold for treatment of de novo coronary artery stenosis: six-month clinical and imaging outcomes. Circulation. 2010 Nov 30;122(22):2301-12. doi: 10.1161/CIRCULATIONAHA.110.970772. Epub 2010 Nov 15.
PubMed 21098436Serruys PW, Onuma Y, Dudek D, Smits PC, Koolen J, Chevalier B, de Bruyne B, Thuesen L, McClean D, van Geuns RJ, Windecker S, Whitbourn R, Meredith I, Dorange C, Veldhof S, Hebert KM, Sudhir K, Garcia-Garcia HM, Ormiston JA. Evaluation of the second generation of a bioresorbable everolimus-eluting vascular scaffold for the treatment of de novo coronary artery stenosis: 12-month clinical and imaging outcomes. J Am Coll Cardiol. 2011 Oct 4;58(15):1578-88. doi: 10.1016/j.jacc.2011.05.050.
PubMed 21958884Dudek D, Onuma Y, Ormiston JA, Thuesen L, Miquel-Hebert K, Serruys PW. Four-year clinical follow-up of the ABSORB everolimus-eluting bioresorbable vascular scaffold in patients with de novo coronary artery disease: the ABSORB trial. EuroIntervention. 2012 Jan;7(9):1060-1. doi: 10.4244/EIJV7I9A168.
PubMed 21959320Ormiston J, Webster M. Absorbable coronary stents. Lancet. 2007 Jun 2;369(9576):1839-1840. doi: 10.1016/S0140-6736(07)60829-0. No abstract available.
PubMed 17544749Ramcharitar S, Serruys PW. Fully biodegradable coronary stents : progress to date. Am J Cardiovasc Drugs. 2008;8(5):305-14. doi: 10.2165/00129784-200808050-00003.
PubMed 18828642Macaya C, Moreno R. Bioabsorbable drug-eluting stents: the future of coronary angioplasty? Nat Clin Pract Cardiovasc Med. 2008 Oct;5(10):598-9. doi: 10.1038/ncpcardio1306. Epub 2008 Aug 5.
PubMed 18679382Colombo A, Sharp AS. The bioabsorbable stent as a virtual prosthesis. Lancet. 2009 Mar 14;373(9667):869-70. doi: 10.1016/S0140-6736(09)60521-3. No abstract available.
PubMed 19286066
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French Observatory Evaluating the Use of Intracoronary Prosthesis ABSORB BVS
- ClinicalTrials.gov ID
- NCT02238054
- Acronym / sponsor ID
- FRANCE-ABSORB / 14249
- Conditions
- Intracoronary Angioplasty
- Keywords
- Cardiology, Intracoronary angioplasty, Bioresorbable stent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,072 participants (actual)
- Lead sponsor
- French Cardiology SocietyUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 12 Sep 2014 (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.
Observational Study, French, prospective, multicenter rated using intravascular prosthesis ABSORB BVS.
ABSORB BVS is a prosthesis of a new type. This study will prospectively evaluate all procedures for coronary angioplasty with implantation of at least one BVS with a clinical follow-up of all patients implanted with ABSORB BVS. This national observatory will collect all the events related to product and / or to procedure
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ABSORB BVS | – | –All patients with a coronary angioplasty procedure and the implantation of at least one ABSORB BVS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All the departments of Cardiology, from French health institutions, who are authorized to implement, may participate in the observatory. It is estimated that this procedure will be performed by 50 to 60 sites performing the installation of BVS. The list of centers is scalable, their number can be expected to increase.
Key inclusion criteria (4 listed)
- Patient affiliated to the National Health Insurance Scheme
- Patient able to assess and understand the risks, benefits and alternative treatments laying of ABSORB, to agree to participate in the study (by signing the informed consent after having read the newsletter)
- Patients for whom a procedure is performed coronary angioplasty with implantation of at least one BVS.
- Patient allowing the follow-up as defined in the study
Key exclusion criteria (3 listed)
- Pregnant patient
- Patient that can not give informed consent
- Patient with in-stent restenosis or saphenous vein bypass
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Major Adverse Cardiac Events at 1 year
Time frame: 1 year
At 1 year of follow-up, to evaluate the rate of MACE (Major Adverse Cardiac Events) defined as follows: * Death from cardiac causes * Myocardial Infarction * Rates of target lesion revascularization (TLR) of ischemic origin (ID-TLR) * Surgery unscheduled bypass graft (CABG)
2 secondary outcomes
Target vessel revascularization at 1 year
Time frame: 1 year
Rate of stent thrombosis at 1 year
Time frame: 1 year
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 22 Sep 2022.
- Background: PubMed 2950322Sigwart U, Puel J, Mirkovitch V, Joffre F, Kappenberger L. Intravascular stents to prevent occlusion and restenosis after transluminal angioplasty. N Engl J Med. 1987 Mar 19;316(12):701-6. doi: 10.1056/NEJM198703193161201.
- Background: PubMed 449946Gruntzig AR, Senning A, Siegenthaler WE. Nonoperative dilatation of coronary-artery stenosis: percutaneous transluminal coronary angioplasty. N Engl J Med. 1979 Jul 12;301(2):61-8. doi: 10.1056/NEJM197907123010201.
- Background: PubMed 8041413Serruys PW, de Jaegere P, Kiemeneij F, Macaya C, Rutsch W, Heyndrickx G, Emanuelsson H, Marco J, Legrand V, Materne P, et al. A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. Benestent Study Group. N Engl J Med. 1994 Aug 25;331(8):489-95. doi: 10.1056/NEJM199408253310801.
- Background: PubMed 16452560Serruys PW, Kutryk MJ, Ong AT. Coronary-artery stents. N Engl J Med. 2006 Feb 2;354(5):483-95. doi: 10.1056/NEJMra051091. No abstract available.
- Background: PubMed 12050336Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnar F, Falotico R; RAVEL Study Group. Randomized Study with the Sirolimus-Coated Bx Velocity Balloon-Expandable Stent in the Treatment of Patients with de Novo Native Coronary Artery Lesions. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002 Jun 6;346(23):1773-80. doi: 10.1056/NEJMoa012843.
- Background: PubMed 18021868Abbott JD, Voss MR, Nakamura M, Cohen HA, Selzer F, Kip KE, Vlachos HA, Wilensky RL, Williams DO. Unrestricted use of drug-eluting stents compared with bare-metal stents in routine clinical practice: findings from the National Heart, Lung, and Blood Institute Dynamic Registry. J Am Coll Cardiol. 2007 Nov 20;50(21):2029-36. doi: 10.1016/j.jacc.2007.07.071.
- Background: PubMed 18342684Ormiston JA, Serruys PW, Regar E, Dudek D, Thuesen L, Webster MW, Onuma Y, Garcia-Garcia HM, McGreevy R, Veldhof S. A bioabsorbable everolimus-eluting coronary stent system for patients with single de-novo coronary artery lesions (ABSORB): a prospective open-label trial. Lancet. 2008 Mar 15;371(9616):899-907. doi: 10.1016/S0140-6736(08)60415-8.
- Background: PubMed 19286089Serruys PW, Ormiston JA, Onuma Y, Regar E, Gonzalo N, Garcia-Garcia HM, Nieman K, Bruining N, Dorange C, Miquel-Hebert K, Veldhof S, Webster M, Thuesen L, Dudek D. A bioabsorbable everolimus-eluting coronary stent system (ABSORB): 2-year outcomes and results from multiple imaging methods. Lancet. 2009 Mar 14;373(9667):897-910. doi: 10.1016/S0140-6736(09)60325-1.
- Background: PubMed 21098436Serruys PW, Onuma Y, Ormiston JA, de Bruyne B, Regar E, Dudek D, Thuesen L, Smits PC, Chevalier B, McClean D, Koolen J, Windecker S, Whitbourn R, Meredith I, Dorange C, Veldhof S, Miquel-Hebert K, Rapoza R, Garcia-Garcia HM. Evaluation of the second generation of a bioresorbable everolimus drug-eluting vascular scaffold for treatment of de novo coronary artery stenosis: six-month clinical and imaging outcomes. Circulation. 2010 Nov 30;122(22):2301-12. doi: 10.1161/CIRCULATIONAHA.110.970772. Epub 2010 Nov 15.
- Background: PubMed 21958884Serruys PW, Onuma Y, Dudek D, Smits PC, Koolen J, Chevalier B, de Bruyne B, Thuesen L, McClean D, van Geuns RJ, Windecker S, Whitbourn R, Meredith I, Dorange C, Veldhof S, Hebert KM, Sudhir K, Garcia-Garcia HM, Ormiston JA. Evaluation of the second generation of a bioresorbable everolimus-eluting vascular scaffold for the treatment of de novo coronary artery stenosis: 12-month clinical and imaging outcomes. J Am Coll Cardiol. 2011 Oct 4;58(15):1578-88. doi: 10.1016/j.jacc.2011.05.050.
- Background: PubMed 21959320Dudek D, Onuma Y, Ormiston JA, Thuesen L, Miquel-Hebert K, Serruys PW. Four-year clinical follow-up of the ABSORB everolimus-eluting bioresorbable vascular scaffold in patients with de novo coronary artery disease: the ABSORB trial. EuroIntervention. 2012 Jan;7(9):1060-1. doi: 10.4244/EIJV7I9A168.
- Background: PubMed 17544749Ormiston J, Webster M. Absorbable coronary stents. Lancet. 2007 Jun 2;369(9576):1839-1840. doi: 10.1016/S0140-6736(07)60829-0. No abstract available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Intracoronary Angioplasty, run by French Cardiology Society at 1 site in France.
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 22 Sep 2022. 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 France. 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?
Major Adverse Cardiac Events at 1 year (time frame: 1 year). 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 NCT02238054, which also lists 35 linked publications.
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 22 Sep 2022.