Coronary StenosisNCT02421016
Test Efficacy With Bioresorbable Polymer Coating Versus Bioresorbable Polymer Backbone (ISAR-RESORB)
A study testing SYNERGY EES and ABSORB [BVS] in people with Coronary Stenosis, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.
Trial summary
The bioresorbable polymer SYNERGY EES exhibits a favourable vascular healing profile in patients undergoing coronary intervention for de novo lesions. Specifically, the SYNERGY EES is superior to the ABSORB bioresorbable vascular scaffold in terms of antirestenotic efficacy as assessed by angiography at 6-8 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Stenosis
- What is being tested?
- SYNERGY EES and ABSORB [BVS]
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteGermany
- Study dates
- May 2015to Apr 2017
- 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 ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50% de novo stenosis located in native coronary vessels (max. 2 lesions in 2 separate vessels)
- Reference diameter ≥2.5 mm and ≤3.9 mm
- Lesion length <28 mm
- Written, informed consent by the patient for participation in the study
Who cannot join
- Cardiogenic shock
- Acute ST-elevation myocardial infarction within 48 hours from symptom onset.
- Target lesion located in left main trunk or bypass graft
- Severe calcification of the lesion
- Target lesion contains a side branch (diameter ≥2mm) or a bifurcation or is located 2 mm away from a bifurcation
- Ostial lesions
Show all 13Show fewer
- Severe vessel tortuosity
- Renal insufficiency (most recent serum creatinine within the last 72h prior to randomization > 2 mg/dl or 177 µmol/l)
- Malignancies or other co-morbid conditions with life expectancy less than 12 months or that may result in protocol non-compliance
- Pregnancy, present (positive pregnancy test), suspected or planned, breast feeding
- Contraindications or allergy to platinum, chromium, everolimus or the inability to take antiplatelet therapy for at least 6 months after stenting; known allergy to PLLA, PDLLA or PLGA polymer
- Previous enrollment in this trial
- Patient's inability to fully cooperate with the study protocol
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Deutsches Herzzentrum München
Munich, Bavaria, 80636
Robert Byrne, MB BCh PhD, +49-89-1218- ext. 4587, byrne@dhm.mhn.de
Salvatore Cassese, MD, +49-89-1218- ext. 4578, cassese@dhm.mhn.de
About this study
Official title: A Prospective, Randomized Trial of SYNERGY Bioresorbable Polymer Coated Stents Versus ABSORB Bioresorbable Backbone Stents in Patients Undergoing Coronary Stenting (ISAR-RESORB)
The bioresorbable polymer SYNERGY EES exhibits a favourable vascular healing profile in patients undergoing coronary intervention for de novo lesions. Specifically, the SYNERGY EES is superior to the ABSORB bioresorbable vascular scaffold in terms of antirestenotic efficacy as assessed by angiography at 6-8 months.
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. To address this issue recent technological advances have focused on bioresorbable polymer coatings and the development of stents with fully resorbable backbones.
Newer generation metallic DES with bioresorbable polymer coatings have been shown to improve vascular healing after coronary stenting. In particular a novel thin-strut bioresorbable polymer everolimus-eluting stent (EES, SYNERGY, Boston Scientific Corp., Natick, MA, USA) has shown high angiographic antirestenotic efficacy as well as high clinical efficacy and safety in early randomized trials. In addition, DES with bioresorbable backbones represent an alternative approach to ensure short-term vessel scaffolding and drug delivery with enhanced vessel healing. The everolimus-eluting bioresorbable backbone stent (ABSORB bioresorbable vascular scaffold [BVS], Abbott Vascular, Santa Rosa, CA, USA) is the most-extensively studied device in this class and early reports in selected patients show encouraging clinical results. However requirement for thicker stent struts and more careful lesion preparation has led to concerns that potential clinical benefits may be offset by erosion of early antirestenotic efficacy and occurrence of clinical events related to limitations of device deployment.
At present there is a lack of randomized clinical trial data examining outcomes of patients treated with these two alternative strategies. The aim of the current ISAR-RESORB study is to test the clinical performance of the bioresorbable-polymer SYNERGY with that of the ABSORB BVS in patients undergoing PCI of de novo coronary lesions. The primary endpoint will be percentage diameter stenosis at protocol-mandated 6-8 month angiographic follow-up. Secondary clinical endpoint will be assessed at 12 months. Sample size calculation is based on a superiority hypothesis for SYNERGY versus ABSORB BVS. It is planned to enrol a total of 230 patients.
- Conditions
- Coronary Stenosis
- Being tested
- SYNERGY EES, ABSORB [BVS]
- Keywords
- De novo stenosis, bioresorbable polymer coating, bioresorbable polymer backbone
- Medical subject headings
- Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYNERGY EESDevice
Bioresorbable polymer everolimus-eluting stent
ABSORB [BVS]Device
Everolimus-eluting bioresorbable backbone stent
| Study group | Role | What they receive |
|---|---|---|
| SYNERGY EES | Experimental | Bioresorbable polymer everolimus-eluting stent Receives: Device: SYNERGY EES |
| ABSORB [BVS] | Active comparator | Everolimus-eluting bioresorbable backbone stent Receives: Device: ABSORB [BVS] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage diameter stenosis (in-stent) by quantitative coronary angiography analysis
Measured: at 6-8 months
Secondary outcomes (4)
Composite of cardiac death/target vessel-myocardial infarction (MI)/ target lesion revascularization (TLR) (Device-oriented composite endpoint)
Measured: at 12 months
Composite of death/any MI/all revascularization (Patient-oriented composite endpoint)
Measured: at 12 months
Composite of cardiovascular death or MI
Measured: at 12 months
Stent Thrombosis
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2016 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary StenosisStudies 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
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Byrne, MB BCh PhD, Principal investigator, Deutsches Herzzentrum München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02421016
- Sponsor's protocol ID
- GE IDE No S03914
- Status last verified
- Apr 2015
- First submitted
- 9 Apr 2015
- Last updated
- 2 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Trial of SYNERGY Bioresorbable Polymer Coated Stents Versus ABSORB Bioresorbable Backbone Stents in Patients Undergoing Coronary Stenting (ISAR-RESORB)
- ClinicalTrials.gov ID
- NCT02421016
- Acronym / sponsor ID
- GE IDE No S03914
- Conditions
- Coronary Stenosis
- Keywords
- De novo stenosis, bioresorbable polymer coating, bioresorbable polymer backbone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 20 Apr 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 bioresorbable polymer SYNERGY EES exhibits a favourable vascular healing profile in patients undergoing coronary intervention for de novo lesions. Specifically, the SYNERGY EES is superior to the ABSORB bioresorbable vascular scaffold in terms of antirestenotic efficacy as assessed by angiography at 6-8 months.
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. To address this issue recent technological advances have focused on bioresorbable polymer coatings and the development of stents with fully resorbable backbones.
Newer generation metallic DES with bioresorbable polymer coatings have been shown to improve vascular healing after coronary stenting. In particular a novel thin-strut bioresorbable polymer everolimus-eluting stent (EES, SYNERGY, Boston Scientific Corp., Natick, MA, USA) has shown high angiographic antirestenotic efficacy as well as high clinical efficacy and safety in early randomized trials. In addition, DES with bioresorbable backbones represent an alternative approach to ensure short-term vessel scaffolding and drug delivery with enhanced vessel healing. The everolimus-eluting bioresorbable backbone stent (ABSORB bioresorbable vascular scaffold [BVS], Abbott Vascular, Santa Rosa, CA, USA) is the most-extensively studied device in this class and early reports in selected patients show encouraging clinical results. However requirement for thicker stent struts and more careful lesion preparation has led to concerns that potential clinical benefits may be offset by erosion of early antirestenotic efficacy and occurrence of clinical events related to limitations of device deployment.
At present there is a lack of randomized clinical trial data examining outcomes of patients treated with these two alternative strategies. The aim of the current ISAR-RESORB study is to test the clinical performance of the bioresorbable-polymer SYNERGY with that of the ABSORB BVS in patients undergoing PCI of de novo coronary lesions. The primary endpoint will be percentage diameter stenosis at protocol-mandated 6-8 month angiographic follow-up. Secondary clinical endpoint will be assessed at 12 months. Sample size calculation is based on a superiority hypothesis for SYNERGY versus ABSORB BVS. It is planned to enrol a total of 230 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SYNERGY EES | Experimental | Device: SYNERGY EESBioresorbable polymer everolimus-eluting stent |
| ABSORB [BVS] | Active comparator | Device: ABSORB [BVS]Everolimus-eluting bioresorbable backbone stent |
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 ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50% de novo stenosis located in native coronary vessels (max. 2 lesions in 2 separate vessels)
- Reference diameter ≥2.5 mm and ≤3.9 mm
- Lesion length <28 mm
- Written, informed consent by the patient for participation in the study
Key exclusion criteria (13 listed)
- Cardiogenic shock
- Acute ST-elevation myocardial infarction within 48 hours from symptom onset.
- Target lesion located in left main trunk or bypass graft
- Severe calcification of the lesion
- Target lesion contains a side branch (diameter ≥2mm) or a bifurcation or is located 2 mm away from a bifurcation
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 |
|---|---|---|
| SYNERGY EESBioresorbable polymer everolimus-eluting stent | Device | SYNERGY EES |
| ABSORB [BVS]Everolimus-eluting bioresorbable backbone stent | Device | ABSORB [BVS] |
Primary outcome
Percentage diameter stenosis (in-stent) by quantitative coronary angiography analysis
Time frame: at 6-8 months
4 secondary outcomes
Composite of cardiac death/target vessel-myocardial infarction (MI)/ target lesion revascularization (TLR) (Device-oriented composite endpoint)
Time frame: at 12 months
Composite of death/any MI/all revascularization (Patient-oriented composite endpoint)
Time frame: at 12 months
Composite of cardiovascular death or MI
Time frame: at 12 months
Stent Thrombosis
Time frame: at 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2015.
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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 Byrne, MB BCh PhD principal investigator
Deutsches Herzzentrum München
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SYNERGY EES and ABSORB [BVS] in people with Coronary Stenosis, run by Deutsches Herzzentrum Muenchen at 1 site 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 13 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 2 Jun 2015. 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 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?
Contact Robert Byrne, MB BCh PhD (+49 89 1218 ext. 4587, byrne@dhm.mhn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage diameter stenosis (in-stent) by quantitative coronary angiography analysis (time frame: at 6-8 months). 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 2 Jun 2015.