Optimal Treatment for Coronary Drug Eluting Stent In-stent Restenosis

Launched by SEMMELWEIS UNIVERSITY HEART AND VASCULAR CENTER · Apr 22, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at the best ways to treat a condition called in-stent restenosis, which is when a treated artery narrows again after a coronary stent has been placed. Researchers want to compare the safety and effectiveness of three different treatments: a special balloon coated with sirolimus (called Magic Touch), another balloon coated with paclitaxel and dextran (called Emperor), and a new type of stent that releases a medication called everolimus (called Xience).

To participate in the trial, patients should be between the ages of 65 and 74 and are being treated for restenosis from a drug-eluting stent. Patients will be randomly assigned to one of the three treatment options and will have the chance to join an additional study looking closely at their arteries using advanced imaging techniques. It's important to note that people who have had sudden cardiac death or are pregnant or nursing cannot participate in this trial. Overall, this study aims to find out which treatment works best for patients facing this common complication after stent placement.

Gender

ALL

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