Optimal Treatment for Coronary Drug Eluting Stent In-stent Restenosis
OPtimal TrEatment for CoroNary Drug Eluting Stent In-Stent Restenosis: Paclitaxel Versus Sirolimus Coated Balloons Versus Everolimus Eluting Stents - the OPEN ISR Study
Semmelweis University Heart and Vascular Center
150 participants
Apr 26, 2021
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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 Criteria2
- Patients undergoing coronary angiography after sudden cardiac death
- Pregnant or nursing
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Interventions
Intravascular devices will be assessed for the management of prior implanted drug eluting stent restenosis management.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT04862052