Comparing treatments for coronary 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
This study is testing three different treatments to see which one works best for patients who have had a blockage in their heart stents.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Semmelweis University Heart and Vascular Center Academic / other |
| Locations | 2 sites (Budapest, Budapest and 1 other locations) |
| Trial ID | NCT04862052 on ClinicalTrials.gov |
What this trial studies
This open-label, randomized study aims to evaluate the safety and efficacy of three different interventions for managing in-stent restenosis in patients with drug-eluting stents. The treatments being compared include the Magic Touch sirolimus-coated balloon, the Emperor paclitaxel and dextran-coated balloon, and the Xience chromium-cobalt everolimus-eluting stent. Patients will be enrolled based on their suitability for all three treatment options, and a subset may participate in an optical coherence tomography sub-study.
Who should consider this trial
Good fit: Ideal candidates are patients admitted for intervention of drug-eluting stent restenosis who meet the criteria for all three treatment arms.
Not a fit: Patients undergoing coronary angiography after sudden cardiac death or those who are pregnant or nursing may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients experiencing restenosis after coronary stent placement.
How similar studies have performed: Other studies have explored various interventions for stent restenosis, but this specific comparison of these three methods is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Budapest, Budapest and 1 other locations
- Semmelweis University Heart and Vascular Center — Budapest, Budapest, Hungary (Recruiting)
- University of Szeged, Department of Invasive Cardiology — Szeged, Csongád-Csanád, Hungary (Recruiting)
Study contacts
- Principal investigator: István F Édes, MD PhD — Semmelweis University Heart and Vascular Center
- Study coordinator: István F Édes, MD PhD
- Email: edes789@gmail.com
- Phone: +3614586810
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.