Treatment of Coronary In-stent Restenosis (ISR) by a Sirolimus Coated or a Paclitaxel Coated Balloon

Not Applicable

Completed

• Conditions: Coronary Restenosis
• Interventions: Combination Product: Sirolimus coated balloon; Combination Product: Paclitaxel coated balloon

• Registration Number: NCT03242096
• Lead Sponsor: InnoRa GmbH

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

Study Timeline

• Study Start: 2017-07-21
• Study First Submitted: 2017-07-31
• Study First Submitted QC: 2017-08-05
• Study First Posted: 2017-08-08
• Primary Completion: 2020-08-01
• Study Completion: 2021-01-31
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-24
• Last Update Posted: 2021-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sirolimus coated balloon	Sirolimus coated balloon	Treatment of in-stent restenosis with a sirolimus coated balloon
Paclitaxel coated balloon	Paclitaxel coated balloon	Treatment of in-stent restenosis with a paclitaxel coated balloon

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
MACE	6 and 12 months	cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization
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
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)

Trial Locations

Locations (5)

Dept. of Internal Medicine II; 🇩🇪 Ulm, Germany

Universitätsspital Basel; 🇨🇭 Basel, Switzerland

Deutsches Zentrum für Herz und Kreislauf; 🇩🇪 Mainz, Germany

Klinik für Innere Medizin und Kardiologie; 🇩🇪 Dresden, Germany

Clinical and Experimental Interventional Cardiology; 🇩🇪 Homburg, Saarland, Germany