Coronary Restenosis
Conditions
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
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
Interventions
COMBINATION_PRODUCTSirolimus 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)
COMBINATION_PRODUCTPaclitaxel 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)
Sponsors
InnoRa GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Blinded QCA for primary outcome
Intervention model 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)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
* Chronic renal insufficiency with serum creatinine levels \> 2.0 mg per deciliter * Known hypersensitivity or contraindications to aspirin, heparin, clopidogrel, ticlopidine or sirolimus, and sensitivity to contrast media not amenable to premedication * Concomitant medical illness associated with a life-expectancy of less than two year * Lesion length (ISR) \> 35 mm, reference vessel diameter \< 2.5 mm
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| late lumen loss in-lesion at 6 months | 6 months | late lumen loss in-lesion at 6 months assessed by blinded QCA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Germany, Switzerland
Outcome results
None listed