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
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
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)
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)
Clinical and Experimental Interventional Cardiology
Homburg, Saarland, Germany
Klinik für Innere Medizin und Kardiologie
Dresden, Germany
Deutsches Zentrum für Herz und Kreislauf
Mainz, Germany
Dept. of Internal Medicine II
Ulm, Germany
late lumen loss in-lesion at 6 months
late lumen loss in-lesion at 6 months assessed by blinded QCA
Time frame: 6 months
Procedural Success
\< 30% final stenosis, TIMI III flow, no flow-limiting dissection, and the absence of in-hospital MACE
Time frame: during hospital stay of index procedure
MACE
cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization
Time frame: 6 and 12 months
Individual clinical endpoints
stent thrombosis, cardiac death, target lesion myocardial infarction, clinically driven target lesion revascularization, binary restenosis (stenosis ≥ 50% at follow-up angiography)
Time frame: 6 and 12 months
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Universitätsspital Basel
Basel, Switzerland