Treatment of Coronary In-stent Restenosis (ISR) by a Sirolimus Coated or a Paclitaxel Coated Balloon
Study Details
Study Description
Brief Summary
Treatment of coronary in-stent restenosis (ISR) by a sirolimus coated SEQUENT® SCB RAPID EXCHANGE PTCA balloon catheter or a paclitaxel coated SEQUENT® PLEASE PTCA balloon catheter
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Experimental intervention: Predilatation of coronary ISR with POBA followed by a sirolimus coated SeQuent®SCB balloon balloon (sirolimus 4.0 μg/mm²)
Control intervention: Predilatation of coronary ISR with POBA followed by a paclitaxel coated SeQuent®Please balloon or SeQuent®Please NEO balloon (paclitaxel 3.0 μg/mm²)
Duration of intervention per patient: minutes
Follow-up per patient: 30 days telephone call; 6 months angiographic + 12 months clinical follow up
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Sirolimus coated balloon Treatment of in-stent restenosis with a sirolimus coated balloon |
Combination Product: Sirolimus coated balloon
Predilatation of coronary ISR with POBA (balloon-to-stent ratio 1:1) followed by a sirolimus coated balloon (SeQuent®SCB balloon with sirolimus 4.0 μg/mm²)
|
| Active Comparator: Paclitaxel coated balloon Treatment of in-stent restenosis with a paclitaxel coated balloon |
Combination Product: Paclitaxel coated balloon
Predilatation of coronary ISR with POBA (balloon-to-stent ratio 1:1) followed by a paclitaxel coated balloon (SeQuent®Please balloon or SeQuent®Please NEO balloon with paclitaxel 3.0 μg/mm²) (paclitaxel 3.0 μg/mm²)
|
Outcome Measures
Primary Outcome Measures
- late lumen loss in-lesion at 6 months [6 months]
late lumen loss in-lesion at 6 months assessed by blinded QCA
Secondary Outcome Measures
- Procedural Success [during hospital stay of index procedure]
< 30% final stenosis, TIMI III flow, no flow-limiting dissection, and the absence of in-hospital MACE
- MACE [6 and 12 months]
cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization
- Individual clinical endpoints [6 and 12 months]
stent thrombosis, cardiac death, target lesion myocardial infarction, clinically driven target lesion revascularization, binary restenosis (stenosis ≥ 50% at follow-up angiography)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
18 years of age
-
Clinical evidence of stable or unstable angina (acute coronary syndrome) or a positive functional study
-
Patients with ≤ 2 primary in-stent restenosis (ISR) lesions (≥ 70% diameter stenosis by visual estimation or ≥50% and positive functional study) including margin-stenosis with max 5 mm distance to the stent
Exclusion Criteria:
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Chronic renal insufficiency with serum creatinine levels > 2.0 mg per deciliter
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Known hypersensitivity or contraindications to aspirin, heparin, clopidogrel, ticlopidine or sirolimus, and sensitivity to contrast media not amenable to premedication
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Concomitant medical illness associated with a life-expectancy of less than two year
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Lesion length (ISR) > 35 mm, reference vessel diameter < 2.5 mm
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinical and Experimental Interventional Cardiology | Homburg | Saarland | Germany | 66421 |
| 2 | Klinik für Innere Medizin und Kardiologie | Dresden | Germany | 01307 | |
| 3 | Deutsches Zentrum für Herz und Kreislauf | Mainz | Germany | 55131 | |
| 4 | Dept. of Internal Medicine II | Ulm | Germany | ||
| 5 | Universitätsspital Basel | Basel | Switzerland | 4031 |
Sponsors and Collaborators
- InnoRa GmbH
Investigators
- Principal Investigator: Bruno Scheller, MD, University of Saarland
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SI-ISR-01