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

InnoRa

Status

Completed

Conditions

Coronary Restenosis

Treatments

Combination Product: Paclitaxel coated balloon

Combination Product: Sirolimus coated balloon

Study type

Interventional

Funder types

Industry

Identifiers

NCT03242096

SI-ISR-01

Details and patient eligibility

About

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

Full 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

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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