Optimal Treatment for Coronary Drug Eluting Stent In-stent Restenosis (OPEN-ISR)

Semmelweis University

Status: Enrolling

Conditions: Coronary Stent Restenosis

Treatments: Procedure: Intravascular management of prior implanted coronary drug eluting stent restenosis

Study type: Interventional

Funder types: Other

Identifiers

NCT04862052

OPEN ISR - 001

Details and patient eligibility

About

The aim of this open label, randomized study is to compare the safety and efficacy of three different methods to handle coronary drug eluting stent (DES) in-stent restenosis (ISR).

These are the:

• Magic Touch - sirolimus coated balloon
• Emperor - paclitaxel and dextran coated balloon
• Xience - chromium-cobalt everolimus eluting stent

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients admitted for intervention of drug eluting stent restenosis
• Restenosis suitable for all three treatment arms as per 'instructions for use' of the devices
• Optional enrollment in the optical coherence tomography sub-study (10-20% of patients)

Exclusion criteria

• Patients undergoing coronary angiography after sudden cardiac death
• Pregnant or nursing

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

Xience chromium-cobalt everolimus eluting stent

Active Comparator group

Description:

The Xience chromium-cobalt everolimus eluting stent will be evaluated in prior implanted coronary drug eluting stent restenosis.

Treatment:

Procedure: Intravascular management of prior implanted coronary drug eluting stent restenosis

Emperor paclitaxel coated balloon

Experimental group

Description:

The Emperor paclitaxel coated balloon will be evaluated in prior implanted coronary drug eluting stent restenosis.

Treatment:

Procedure: Intravascular management of prior implanted coronary drug eluting stent restenosis

Magic Touch sirolimus coated balloon

Experimental group

Description:

The Magic Touch sirolimus coated balloon will be evaluated in prior implanted coronary drug eluting stent restenosis.

Treatment:

Procedure: Intravascular management of prior implanted coronary drug eluting stent restenosis