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

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

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