Cardiovascular DiseaseISAR-Absorb MINCT01942070
A Prospective, Randomized Trial of BVS Veruss EES in Patients Undergoing Coronary Stenting for Myocardial Infarction
A study testing Bioresorbable vascular scaffold and Durable polymer everolimus-eluting metallic stent in people with Cardiovascular Disease and Myocardial Infarction, run by Deutsches Herzzentrum Muenchen at 2 sites in Germany.
Trial summary
The aim of the current study is to test the clinical performance of the everolimus-eluting BVS compared with that of the durable polymer everolimus-eluting stent (EES) in patients undergoing PCI in the setting of acute MI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Disease, Myocardial Infarction, Thrombus
- What is being tested?
- Bioresorbable vascular scaffold and Durable polymer everolimus-eluting metallic stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 262 participants
- Where
- 2 sitesGermany
- Study dates
- Sep 2013to Mar 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 years or older with acute ST-elevation myocardial infarction or non ST-elevation myocardial infarction with angiographically confirmed thrombus
- Planned stent implantation in de novo lesions in native vessels or coronary bypass grafts with reference vessel diameter ≥2.5 mm and ≤3.9 mm
- Written, informed consent by the patient or her/his legally-authorized representative for participation in the study
- In women with childbearing potential a negative pregnancy test is mandatory
Who cannot join
- Target lesion located in the left main trunk
- Severely calcified lesions
- Bifurcation lesions with side branch diameter > 2mm
- In-stent restenosis
- Contraindications to antiplatelet therapy, cobalt chrome, everolimus, polylactic acid
- Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance
Show all 9Show fewer
- Pregnancy (present, suspected or planned) or positive pregnancy test.
- Previous enrolment in this trial
- Patient's inability to fully cooperate with the study protocol
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Deutsches Herzzentrum Munich
Munich, Bavaria, 80636
Klinikum Rechts der Isar
Munich, Bavaria, 81675
About this study
Official title: Intracoronary Scaffold Assessment a Randomised Evaluation of Absorb in Myocardial Infarction (ISAR-Absorb MI) A Prospective, Randomized Trial of BVS Veruss EES in Patients Undergoing Coronary Stenting for Myocardial Infarction
The aim of the current study is to test the clinical performance of the everolimus-eluting BVS compared with that of the durable polymer everolimus-eluting stent (EES) in patients undergoing PCI in the setting of acute MI.
Read the detailed description
Percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation currently represents the dominant treatment strategy in patients undergoing catheter intervention. However effective neointimal suppression occurs at the cost of a systematic delay in arterial healing in comparison with after bare metal stenting. This underlies a small but significant increased risk of stent thrombosis after DES implantation in comparison with bare metal stent implantation as well as a possible excess of in-stent neoatheroma formation.
Bioresorbable vascular scaffolds (BVS) represent an innovative technology providing short-term vessel scaffolding and drug delivery without the long-term limitations of metallic DES and durable polymer coatings. Potential benefits include restoration of normal vasomotor reactivity, facilitation of positive vessel wall remodelling and facilitation of subsequent bypass grafting of the stented arterial segment. In addition preliminary reports suggest that the process of scaffold biodegradation may promote formation of a cohesive tissue layer covering and stabilizing the underlying atherosclerotic plaque - a so-called plaque-sealing effect. Although initial results with BVS are encouraging, there is a lack of randomized clinical trial data and no data exists for outcomes after BVS implantation in patients undergoing coronary stenting in the setting of acute myocardial infarction (MI).
The aim of the current study is to test the clinical performance of the everolimus-eluting BVS compared with that of the durable polymer everolimus-eluting stent (EES) in patients undergoing PCI in the setting of acute MI. The primary endpoint will be percentage diameter stenosis at protocol-mandated 6-8 month angiographic follow-up. Sample size calculation is based on a non-inferiority assumption in relation to the BVS versus EES. It is planned to enrol a total of 260 patients. Subsequent clinical follow-up will be undertaken out to 2 years.
- Being tested
- Bioresorbable vascular scaffold, Durable polymer everolimus-eluting metallic stent
- Keywords
- Cardiovascular Disease, Myocardial Infarction, Bioresorbable vascular scaffold, Durable polymer everolimus-eluting stent, Primary angioplasty, Stent
- Medical subject headings
- Cardiovascular Diseases, Myocardial Infarction, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioresorbable vascular scaffoldDevice
Also called ABSORB
Durable polymer everolimus-eluting metallic stentDevice
Also called Xience
| Study group | Role | What they receive |
|---|---|---|
| Bioresorbable vascular scaffold | Experimental | Bioresorbable vascular scaffold (BVS) Receives: Device: Bioresorbable vascular scaffold |
| Everolimus-eluting stent | Active comparator | Durable polymer everolimus-eluting metallic stent (EES) Receives: Device: Durable polymer everolimus-eluting metallic stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Diameter Stenosis
Percentage diameter stenosis at coronary angiography at 6-8 months follow-up
Measured: 6-8 months
Secondary outcomes (4)
Device-oriented composite endpoint
Composite of cardiac death/target vessel-myocardial infarction (MI)/ target lesion revascularization (TLR)
Measured: 12 months
Patient-oriented composite endpoint
The composite of death/any MI/all revascularization
Measured: 12 months
Composite of death or MI
The composite of cardiovascular death or MI
Measured: 12 months
Stent thrombosis
The incidence of scaffold or stent thrombosis
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionMar 2018
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies 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
- None (open label)
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert A Byrne, MB PhD, Principal investigator, Deutsches Herzzentrum Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01942070
- Sponsor's protocol ID
- Ge IDE No. I01210
- Acronym
- ISAR-Absorb MI
- Status last verified
- Jul 2018
- First submitted
- 10 Sep 2013
- Last updated
- 9 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cassese S, Katagiri Y, Byrne RA, Brugaletta S, Alfonso F, Raber L, Maeng M, Iniguez A, Kretov E, Onuma Y, Joner M, Sabate M, Laugwitz KL, Windecker S, Kastrati A, Serruys PW. Angiographic and clinical outcomes of STEMI patients treated with bioresorbable or metallic everolimus-eluting stents: a pooled analysis of individual patient data. EuroIntervention. 2020 Mar 20;15(16):1451-1457. doi: 10.4244/EIJ-D-18-01080.
PubMed 30719976Byrne RA, Alfonso F, Schneider S, Maeng M, Wiebe J, Kretov E, Bradaric C, Rai H, Cuesta J, Rivero F, Hoppmann P, Schlichtenmaier J, Christiansen EH, Cassese S, Joner M, Schunkert H, Laugwitz KL, Kastrati A. Prospective, randomized trial of bioresorbable scaffolds vs. everolimus-eluting stents in patients undergoing coronary stenting for myocardial infarction: the Intracoronary Scaffold Assessment a Randomized evaluation of Absorb in Myocardial Infarction (ISAR-Absorb MI) trial. Eur Heart J. 2019 Jan 7;40(2):167-176. doi: 10.1093/eurheartj/ehy710.
PubMed 30520980
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracoronary Scaffold Assessment a Randomised Evaluation of Absorb in Myocardial Infarction (ISAR-Absorb MI) A Prospective, Randomized Trial of BVS Veruss EES in Patients Undergoing Coronary Stenting for Myocardial Infarction
- ClinicalTrials.gov ID
- NCT01942070
- Acronym / sponsor ID
- ISAR-Absorb MI / Ge IDE No. I01210
- Keywords
- Cardiovascular Disease, Myocardial Infarction, Bioresorbable vascular scaffold, Durable polymer everolimus-eluting stent, Primary angioplasty, Stent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Study start
- Sep 2013 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2019 (estimated)
- First posted
- 13 Sep 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 aim of the current study is to test the clinical performance of the everolimus-eluting BVS compared with that of the durable polymer everolimus-eluting stent (EES) in patients undergoing PCI in the setting of acute MI.
Detailed description
Percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation currently represents the dominant treatment strategy in patients undergoing catheter intervention. However effective neointimal suppression occurs at the cost of a systematic delay in arterial healing in comparison with after bare metal stenting. This underlies a small but significant increased risk of stent thrombosis after DES implantation in comparison with bare metal stent implantation as well as a possible excess of in-stent neoatheroma formation.
Bioresorbable vascular scaffolds (BVS) represent an innovative technology providing short-term vessel scaffolding and drug delivery without the long-term limitations of metallic DES and durable polymer coatings. Potential benefits include restoration of normal vasomotor reactivity, facilitation of positive vessel wall remodelling and facilitation of subsequent bypass grafting of the stented arterial segment. In addition preliminary reports suggest that the process of scaffold biodegradation may promote formation of a cohesive tissue layer covering and stabilizing the underlying atherosclerotic plaque - a so-called plaque-sealing effect. Although initial results with BVS are encouraging, there is a lack of randomized clinical trial data and no data exists for outcomes after BVS implantation in patients undergoing coronary stenting in the setting of acute myocardial infarction (MI).
The aim of the current study is to test the clinical performance of the everolimus-eluting BVS compared with that of the durable polymer everolimus-eluting stent (EES) in patients undergoing PCI in the setting of acute MI. The primary endpoint will be percentage diameter stenosis at protocol-mandated 6-8 month angiographic follow-up. Sample size calculation is based on a non-inferiority assumption in relation to the BVS versus EES. It is planned to enrol a total of 260 patients. Subsequent clinical follow-up will be undertaken out to 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bioresorbable vascular scaffold | Experimental | Device: Bioresorbable vascular scaffoldBioresorbable vascular scaffold (BVS) |
| Everolimus-eluting stent | Active comparator | Device: Durable polymer everolimus-eluting metallic stentDurable polymer everolimus-eluting metallic stent (EES) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients 18 years or older with acute ST-elevation myocardial infarction or non ST-elevation myocardial infarction with angiographically confirmed thrombus
- Planned stent implantation in de novo lesions in native vessels or coronary bypass grafts with reference vessel diameter ≥2.5 mm and ≤3.9 mm
- Written, informed consent by the patient or her/his legally-authorized representative for participation in the study
- In women with childbearing potential a negative pregnancy test is mandatory
Key exclusion criteria (9 listed)
- Target lesion located in the left main trunk
- Severely calcified lesions
- Bifurcation lesions with side branch diameter > 2mm
- In-stent restenosis
- Contraindications to antiplatelet therapy, cobalt chrome, everolimus, polylactic acid
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 |
|---|---|---|
| Bioresorbable vascular scaffoldAlso: ABSORB | Device | Bioresorbable vascular scaffold |
| Durable polymer everolimus-eluting metallic stentAlso: Xience | Device | Everolimus-eluting stent |
Primary outcome
Percentage Diameter Stenosis
Time frame: 6-8 months
Percentage diameter stenosis at coronary angiography at 6-8 months follow-up
4 secondary outcomes
Device-oriented composite endpoint
Time frame: 12 months
Patient-oriented composite endpoint
Time frame: 12 months
Composite of death or MI
Time frame: 12 months
Stent thrombosis
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2018.
- Derived from this study: PubMed 30719976Cassese S, Katagiri Y, Byrne RA, Brugaletta S, Alfonso F, Raber L, Maeng M, Iniguez A, Kretov E, Onuma Y, Joner M, Sabate M, Laugwitz KL, Windecker S, Kastrati A, Serruys PW. Angiographic and clinical outcomes of STEMI patients treated with bioresorbable or metallic everolimus-eluting stents: a pooled analysis of individual patient data. EuroIntervention. 2020 Mar 20;15(16):1451-1457. doi: 10.4244/EIJ-D-18-01080.
- Derived from this study: PubMed 30520980Byrne RA, Alfonso F, Schneider S, Maeng M, Wiebe J, Kretov E, Bradaric C, Rai H, Cuesta J, Rivero F, Hoppmann P, Schlichtenmaier J, Christiansen EH, Cassese S, Joner M, Schunkert H, Laugwitz KL, Kastrati A. Prospective, randomized trial of bioresorbable scaffolds vs. everolimus-eluting stents in patients undergoing coronary stenting for myocardial infarction: the Intracoronary Scaffold Assessment a Randomized evaluation of Absorb in Myocardial Infarction (ISAR-Absorb MI) trial. Eur Heart J. 2019 Jan 7;40(2):167-176. doi: 10.1093/eurheartj/ehy710.
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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.
Robert A Byrne, MB PhD principal investigator
Deutsches Herzzentrum Munich
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bioresorbable vascular scaffold and Durable polymer everolimus-eluting metallic stent in people with Cardiovascular Disease and Myocardial Infarction, run by Deutsches Herzzentrum Muenchen at 2 sites in Germany.
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 9 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 9 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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?
Percentage Diameter Stenosis (time frame: 6-8 months). 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 NCT01942070, which also lists 2 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 9 Jul 2018.