Optimal Treatment for Coronary Drug Eluting Stent In-stent Restenosis

Not Applicable

Recruiting

• Conditions: Coronary Stent Restenosis
• Interventions: Procedure: Intravascular management of prior implanted coronary drug eluting stent restenosis

• Registration Number: NCT04862052
• Lead Sponsor: Semmelweis University Heart and Vascular Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-20
• Study First Submitted QC: 2021-04-22
• Study Start: 2021-04-26
• Study First Posted: 2021-04-27
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-22
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Xience chromium-cobalt everolimus eluting stent	Intravascular management of prior implanted coronary drug eluting stent restenosis	The Xience chromium-cobalt everolimus eluting stent will be evaluated in prior implanted coronary drug eluting stent restenosis.
Emperor paclitaxel coated balloon	Intravascular management of prior implanted coronary drug eluting stent restenosis	The Emperor paclitaxel coated balloon will be evaluated in prior implanted coronary drug eluting stent restenosis.
Magic Touch sirolimus coated balloon	Intravascular management of prior implanted coronary drug eluting stent restenosis	The Magic Touch sirolimus coated balloon will be evaluated in prior implanted coronary drug eluting stent restenosis.

Primary Outcome Measures

Name	Time	Method
Occurrence of new onset target vessel myocardial infarction	6 months	New onset myocardial infarction that affects the target vessel treated with either study device
Occurrence of target vessel revascularization of failure	6 months	The need for further revascularization affecting the target vessel treated with either study device, or the failure of the vessel treated by either study device.
Occurrence of target lesion revascularization	6 months	The need for further revascularization of the target lesion after treatment with either study device.

Secondary Outcome Measures

Name	Time	Method
Square millimeter intraluminal gain after treatment	6 months	Intraluminal gain after assigned treatment measured via optical coherence tomography
Endothelium coverage in micrometers	6 months	Mean endothelium thickness of stent struts in micrometres measured via optical coherence tomography
Percentage late lumen loss	6 months	Late lumen loss measured via qualitative coronary angiography in treated segment(s)
Percentage intraluminal gain after treatment	6 months	Intraluminal gain after assigned treatment measured via optical coherence tomography
Square millimetre intraluminal gain after treatment	index procedure	Intraluminal gain after assigned treatment measured via optical coherence tomography
Late lumen loss in square millimetres	6 months	Late lumen loss in square millimetres measured via optical coherence tomography

Trial Locations

Locations (2)

University of Szeged, Department of Invasive Cardiology; 🇭🇺 Szeged, Csongád-Csanád, Hungary

Semmelweis University Heart and Vascular Center; 🇭🇺 Budapest, Hungary