Coronary Artery LesionCompare AbsorbNCT02486068
ABSORB Bioresorbable Scaffold vs. Xience Metallic Stent for Prevention of Restenosis in Patients at High Risk of Restenosis
A study testing ABSORB scaffold and Xience in people with Coronary Artery Lesion, run by European Cardiovascular Research Center at 44 sites in 9 countries.
Trial summary
The primary objectives of this trial are: In patients at high-risk for restenosis, To assess non-inferiority of the everolimus-eluting bioresorbable scaffold (BRS) to the everolimus eluting cobalt chromium metallic stent (EES) in target lesion failure (TLF) at 1 year To assess superiority of the BRS to the EES in TLF… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Lesion
- What is being tested?
- ABSORB scaffold and Xience
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,670 participants
- Where
- 44 sitesin 9 countries
- Study dates
- 28 Sep 2015to Sep 2024
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients (18-75 years old) with at least one of the followings:
- High-risk characteristics for restenosis
- Medically treated Diabetes (oral medication or insulin)
- Multivessel disease of which more than one de-novo target lesion to be treated with the study scaffold/stent
- Complex target lesion
- Single de-novo target lesion satisfying at least one of the following:
Show all 10Show fewer
- Lesion length >28 mm
- Small vessels: Target lesion reference vessel diameter between ≥2.5 mm and ≤2.75mm
- Lesion with pre-existing total occlusion (pre-procedural TIMI = 0)
- Bifurcation with single stent strategy
Who cannot join
- Patients are excluded from this study if they have:
- Age <18 years or >75 years
- Known comorbidities which make patients unable to complete 7-years follow-up
- Female of childbearing potential (and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy
- Pregnant woman
- Breastfeeding woman
Show all 28Show fewer
- Known intolerance to aspirin, heparin, PLLA, everolimus, contrast material
- Cardiogenic Shock (Killip >2)
- PCI with implantation of stents/scaffolds within previous 30 days.
- Active bleeding or coagulopathy or patients at chronic anticoagulation therapy
- Subject is currently participating in another clinical trial that has not yet completed its primary endpoint
- Renal insufficiency (GFR <45 ml/min)
- Life expectancy < 7 years
- Known non-adherence to DAPT
- Patients on oral anticoagulation therapy (including novel oral anticoagulant such as dabigatran, rivaroxaban, apixaban and edoxaban)
- LVEF <30%
- Patients at high bleeding risk who are not suitable for long-term DAPT
- Following lesion characteristics:
- Target lesion reference vessel diameter (RVD) < 2.5 and > 4 mm
- STEMI with RVD of >3.5mm of the culprit target lesion
- Target lesion with in-stent/scaffold thrombosis
- Graft lesions as target lesions
- Aorto-ostial lesion(s)
- Left main lesion
- Severe tortuosity of target vessel
- In-scaffold restenosis
- Bifurcation target lesion with intended 2 stent/scaffold strategy
- Non-target lesion and target lesion in the same epicardial coronary artery (right coronary artery, left circumflex artery or left anterior descending artery)
Trial locations and contacts
44 sites in 9 countries.
44 sites in 9 countries
Germany9 sites
Segeberger Kliniken
Bad Segeberg, 23795
Charité Campus Benjamin Franklin
Berlin, 12203
Universitätsklinikum Köln
Cologne, 50937
Universitätsklinikum Erlangen
Erlangen, 91054
Elisabethkrankenhaus Essen
Essen, 45138
Universitätsklinikum Gießen
Giessen, 33539
Universität Leipzig - Herzzentrum
Leipzig, 04289
Universitätsmedizin Mainz
Mainz, 55131
Klinikum der Universität München
München, 81377
Italy8 sites
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, 24127
Azienda Ospedaliera Brotzu
Cagliari, 09134
Ospedale San Giacomo
Castelfranco Veneto, 31033
Università degli studi Magna Graecia
Catanzaro, 88100
Università degli Studi di Napoli Federico II
Naples, 80131
Azienda Ospedaliera di Padova
Padova, 35128
Arnas Civico Palermo
Palermo, 90127
Azienda Ospedaliero-Universitaria di Parma
Parma, 43126
France5 sites
Clinique Rhône Durance
Avignon, 84082
CHU Clermont-Ferrand
Clermont-Ferrand, 63000
Hôpital Privé Jacques Cartier
Massy, 91300
Clinique Saint-Hilaire
Rouen, 76000
Clinique Pasteur
Toulouse, 31300
Netherlands5 sites
Amphia Ziekenhuis
Breda, 4818
Albert Schweitzer Hospital
Dordrecht, 3300
Catherina Ziekenhuis
Eindhoven, 5623
Erasmus Medisch Centrum
Rotterdam, 3000
Maasstadziekenhuis
Rotterdam, 3079
Poland4 sites
American Heart of Poland
Chrzanów, 40-635
University Hospital Krakow
Krakow, 31-501
Miedziowe Centrum Zdrowia SA
Lubin, 59-301
American Heart of Poland
Tychy, 43-100
Spain4 sites
Hospital del Mar
Barcelona, 8003
Hospital Clinic
Barcelona, 8036
Hospital Clinico San Carlos
Madrid, 28040
Hospital Universitario Marques de Valdecilla
Santander, 39008
Belgium3 sites
Cardiovascular Center Aalst OLV
Aalst, 9300
CHR Citadelle
Leuven, 3000
UZ Leuven
Leuven, 3000
Czechia3 sites
University Hospital Brno
Brno, 62500
Cardiocentre, University Hospital Kralovske
Prague, 10034
Central Military Hospital
Prague, 1200
United Kingdom3 sites
Royal Bournemouth Hospital
Bournemouth, BH7 7DW
Papworth Hospital
Cambridge, CB23 3RE
Freeman Hospital
Newcastle, NE7 7DN
About this study
Official title: ABSORB Bioresorbable Scaffold vs. Xience Metallic Stent for Prevention of Restenosis Following Percutaneous Coronary Intervention in Patients at High Risk of Restenosis
The primary objectives of this trial are:
In patients at high-risk for restenosis,
- To assess non-inferiority of the everolimus-eluting bioresorbable scaffold (BRS) to the everolimus eluting cobalt chromium metallic stent (EES) in target lesion failure (TLF) at 1 year
- To assess superiority of the BRS to the EES in TLF between 3 and 7 years
- Conditions
- Coronary Artery Lesion
- Being tested
- ABSORB scaffold, Xience
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABSORB scaffoldDevice
XienceDevice
| Study group | Role | What they receive |
|---|---|---|
| ABSORB scaffold | Experimental | Patient will undergoes elective or emergent percutaneous coronary intervention and will be treated with ABSORB scaffold. Receives: Device: ABSORB scaffold |
| Xience | Active comparator | Patient will undergoes elective or emergent percutaneous coronary intervention and will be treated with Xience Prime. Receives: Device: Xience |
What is being measured
The primary outcome is the main question the study is designed to answer.
non-inferiority of the everolimus-eluting bioresorbable scaffold (Absorb) to the everolimus eluting cobalt chromium metallic stent (Xience) in target lesion failure (TLF)
Composite of:
- Cardiac death
- Myocardial infarction (MI) in target vessel territory (SCAI consensus for periprocedural MI, 3rd universal definition for spontaneous or other MI)
- Clinically Indicated Target lesion revascularization
Measured: 1 year
Secondary outcomes (3)
superiority of the Absorb to the Xience in TLF between 3 and 7 years
Measured: 5 years
Superiority of the Absorb to the Xience in TLF at 7 years
Measured: 7 years
Superiority of the Absorb to the XIence in cumulative angina rate at 1 year
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 posted1 Jul 2015 (estimated)
- Study start28 Sep 2015
- Primary completion28 Aug 2018 (estimated)
- Study completionSep 2024 (estimated)
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 Artery LesionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,670 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Cardiovascular Research Center
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Pieter Smits, MD, Principal investigator, Maastad hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02486068
- Sponsor's protocol ID
- COMPARE ABSORB
- Acronym
- Compare Absorb
- Status last verified
- Aug 2018
- First submitted
- 24 Jun 2015
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chang CC, Onuma Y, Achenbach S, Barbato E, Chevalier B, Cook S, Dudek D, Escaned J, Gori T, Kocka V, Tarantini G, West NEJ, Morice MC, Tijssen JGP, van Geuns RJ, Smits PC; COMPARE ABSORB trial investigators. Absorb Bioresorbable Scaffold Versus Xience Metallic Stent for Prevention of Restenosis Following Percutaneous Coronary Intervention in Patients at High Risk of Restenosis: Rationale and Design of the COMPARE ABSORB Trial. Cardiovasc Revasc Med. 2019 Jul;20(7):577-582. doi: 10.1016/j.carrev.2019.04.013. Epub 2019 Apr 16.
PubMed 31153846
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ABSORB Bioresorbable Scaffold vs. Xience Metallic Stent for Prevention of Restenosis Following Percutaneous Coronary Intervention in Patients at High Risk of Restenosis
- ClinicalTrials.gov ID
- NCT02486068
- Acronym / sponsor ID
- Compare Absorb / COMPARE ABSORB
- Conditions
- Coronary Artery Lesion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,670 participants (actual)
- Lead sponsor
- European Cardiovascular Research CenterResearch network
- Study start
- 28 Sep 2015 (actual)
- Primary completion
- 28 Aug 2018 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 1 Jul 2015 (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 primary objectives of this trial are:
In patients at high-risk for restenosis,
- To assess non-inferiority of the everolimus-eluting bioresorbable scaffold (BRS) to the everolimus eluting cobalt chromium metallic stent (EES) in target lesion failure (TLF) at 1 year
- To assess superiority of the BRS to the EES in TLF between 3 and 7 years
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABSORB scaffold | Experimental | Device: ABSORB scaffoldPatient will undergoes elective or emergent percutaneous coronary intervention and will be treated with ABSORB scaffold. |
| Xience | Active comparator | Device: XiencePatient will undergoes elective or emergent percutaneous coronary intervention and will be treated with Xience Prime. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- High-risk characteristics for restenosis
- Complex target lesion
Key exclusion criteria (28 listed)
- Patients are excluded from this study if they have:
- Age <18 years or >75 years
- Known comorbidities which make patients unable to complete 7-years follow-up
- Female of childbearing potential (and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy
- Pregnant woman
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 scaffold | Device | ABSORB scaffold |
| Xience | Device | Xience |
Primary outcome
non-inferiority of the everolimus-eluting bioresorbable scaffold (Absorb) to the everolimus eluting cobalt chromium metallic stent (Xience) in target lesion failure (TLF)
Time frame: 1 year
Composite of: * Cardiac death * Myocardial infarction (MI) in target vessel territory (SCAI consensus for periprocedural MI, 3rd universal definition for spontaneous or other MI) * Clinically Indicated Target lesion revascularization
3 secondary outcomes
superiority of the Absorb to the Xience in TLF between 3 and 7 years
Time frame: 5 years
Superiority of the Absorb to the Xience in TLF at 7 years
Time frame: 7 years
Superiority of the Absorb to the XIence in cumulative angina rate at 1 year
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
- Derived from this study: PubMed 31153846Chang CC, Onuma Y, Achenbach S, Barbato E, Chevalier B, Cook S, Dudek D, Escaned J, Gori T, Kocka V, Tarantini G, West NEJ, Morice MC, Tijssen JGP, van Geuns RJ, Smits PC; COMPARE ABSORB trial investigators. Absorb Bioresorbable Scaffold Versus Xience Metallic Stent for Prevention of Restenosis Following Percutaneous Coronary Intervention in Patients at High Risk of Restenosis: Rationale and Design of the COMPARE ABSORB Trial. Cardiovasc Revasc Med. 2019 Jul;20(7):577-582. doi: 10.1016/j.carrev.2019.04.013. Epub 2019 Apr 16.
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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.
Pieter Smits, MD principal investigator
Maastad hospital
44 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ABSORB scaffold and Xience in people with Coronary Artery Lesion, run by European Cardiovascular Research Center at 44 sites in 9 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 10 inclusion and 28 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: status not confirmed, as of the sponsor's last update on 14 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in Germany, Italy, France, Netherlands, Poland and 4 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?
Results are not available in the source record.
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?
non-inferiority of the everolimus-eluting bioresorbable scaffold (Absorb) to the everolimus eluting cobalt chromium metallic stent (Xience) in target lesion failure (TLF) (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 NCT02486068, 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 14 Aug 2018.