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Recruiting NCT04862052
Optimal Treatment for Coronary Drug Eluting Stent In-stent Restenosis
Trial Parameters
Condition Coronary Stent Restenosis
Sponsor Semmelweis University Heart and Vascular Center
Study Type INTERVENTIONAL
Phase N/A
Enrollment 150
Sex ALL
Min Age 18 Years
Max Age 85 Years
Start Date 2021-04-26
Completion 2025-01-01
Interventions
Intravascular management of prior implanted coronary drug eluting stent restenosis
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
Eligibility Criteria
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