Treatment of Coronary De-novo Stenosis by a Sirolimus Coated Balloon or a Paclitaxel Coated Balloon Catheter Malaysia

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

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2021-01-31

Brief Summary

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To examine the treatment of coronary de-novo stenosis with a sirolimus coated balloon versus a paclitaxel coated balloon

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Detailed Description

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To examine the treatment of coronary de-novo stenosis with a sirolimus coated balloon versus a paclitaxel coated balloon. Prospective, multicenter, randomized, single-blind, 70 patients. Experimental intervention: Predilatation of coronary de-novo stenosis followed by a sirolimus coated SeQuent®SCB balloon (sirolimus 4.0 μg/mm²). Control intervention: Predilatation of coronary de-novo stenosis followed by a SeQuent®Please or SeQuent®Please Neo balloon (paclitaxel 3.0 μg/mm²). Follow-up per patient: 30 days telephone call; 6 months angiographic + 12 months. clinical follow up.

Conditions

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Coronary Artery Disease

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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PTCA of coronary de novo lesion PCB

Predilatation of coronary de-novo stenosis followed by a SeQuent®Please or SeQuent®Please Neo balloon (paclitaxel 3.0 μg/mm²)

Group Type ACTIVE_COMPARATOR

PCB PTCA

Intervention Type DEVICE

Predilatation of coronary de-novo stenosis followed by a PCB

PTCA of coronary de novo lesion SCB

Predilatation of coronary de-novo stenosis followed by a sirolimus coated SeQuent®SCB balloon (sirolimus 4.0 μg/mm²)

Group Type EXPERIMENTAL

SCB PTCA

Intervention Type DEVICE

Predilatation of coronary de-novo stenosis followed by a SCB

Interventions

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PCB PTCA

Predilatation of coronary de-novo stenosis followed by a PCB

Intervention Type DEVICE

SCB PTCA

Predilatation of coronary de-novo stenosis followed by a SCB

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Clinical evidence of stable or unstable angina or a positive functional study
* Patients with significant coronary de-novo stenosis (≥ 70% diameter stenosis or intermediate ≥ 50% to \<70% diameter stenosis with positive functional test or symptom of ischemia)
* Successful lesion preparation (no flow-limiting dissection or a residual stenosis \> 30%)

Exclusion Criteria

* Acute myocardial infarction within the past 72 hours (STEMI or NSTEMI)
* Intolerance and / or allergy to Sirolimus
* Intolerance or allergy to Paclitaxel and/or the delivery matrix (main ingredient:

iopromide)

* Patients with an ejection fraction of \< 30 %
* Reference vessel diameter (RVD) \< 2.5 mm
* Contraindication for whichever necessary accompanying medication

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No