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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-21

Study Completion Date

2021-01-31

Brief Summary

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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

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Detailed Description

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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

Conditions

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Coronary Restenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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)

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Blinded QCA for primary outcome

Study Groups

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Sirolimus coated balloon

Treatment of in-stent restenosis with a sirolimus coated balloon

Group Type EXPERIMENTAL

Sirolimus coated balloon

Intervention Type COMBINATION_PRODUCT

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)

Paclitaxel coated balloon

Treatment of in-stent restenosis with a paclitaxel coated balloon

Group Type ACTIVE_COMPARATOR

Paclitaxel coated balloon

Intervention Type COMBINATION_PRODUCT

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)

Interventions

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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)

Intervention Type 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)

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No