Treatment of Coronary In-Stent Restenosis by a Sirolimus (Rapamycin) Coated Balloon 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

2015-12-01

Study Completion Date

2017-12-01

Brief Summary

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The aim of the study is to investigate the non-inferiority of the new sirolimus-coated balloon catheters in comparison to the paclitaxel-coated SQP with regard to acute tolerance, safety and efficacy in coronary DES in-stent restenosis.

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Detailed Description

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The aim of the study is to investigate the non-inferiority of the new sirolimus-coated balloon catheters in comparison to the paclitaxel-coated SQP with regard to acute tolerance, safety and efficacy in coronary DES in-stent restenosis.

Patient population will consist of male and female adults suffering from coronary drug-eluting stent (DES) restenosis, which is to be treated by a study balloon according to the inclusion and exclusion criteria as defined below.

In Late lumen loss lesion (difference between the angiographic in-lesion MLD post procedural and at 6 months follow-up) will be evaluated by quantitative coronary angiography (QCA).

The study will be performed as a single-blind, SQP controlled study in 4 - 6 study centers in 50 patients.

Conditions

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DES In-stent Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Sirolimus coated Balloon

treatment of coronary DES-ISR with a sirolimus coated balloon

Group Type EXPERIMENTAL

Sirolimus coated balloon

Intervention Type DEVICE

Sirolimus coated balloon

Paclitaxel coated balloon (SeQuent Please)

treatment of coronary DES-ISR with a paclitaxel coated balloon

Group Type ACTIVE_COMPARATOR

Paclitaxel coated balloon (SeQuent Please)

Intervention Type DEVICE

Paclitaxel coated balloon (SeQuent Please)

Interventions

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Paclitaxel coated balloon (SeQuent Please)

Intervention Type DEVICE

Sirolimus coated balloon

Intervention Type DEVICE

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 drug-eluting stent in-stent restenosis (DES-ISR) lesions (≥ 70% diameter stenosis by visual estimation or ≥ 50% and positive functional study) including margin stenosis with max 5mm 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, vessel diameter \< 2.5 mm

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No