RIBS V (Restenosis Intra-stent of Bare Metal Stents: Paclitaxel-eluting Balloon vs Everolimus-eluting Stent). A Prospective, Multicenter and Randomized Clinical Trial
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- In-Stent Restenosis
- Sponsor
- Fundación Médica para la Investigación y Desarrollo en el Area Cardiovascular
- Enrollment
- 190
- Locations
- 25
- Primary Endpoint
- Minimal lumen diameter
- Last Updated
- 14 years ago
Overview
Brief Summary
Treatment of patients with bare metal stent restenosis remains a challenge. This study will assess which interventional strategy (paclitaxel-eluting balloon vs everolimus-eluting stent) is superior in the treatment of patients suffering from bare metal stent restenosis.
Detailed Description
Treatment of patients with bare metal stent restenosis remains a major clinical and technical challenge. Currently, drug-eluting stents are widely used in the management of these patients. Recently, the value of the paclitaxel-eluting balloon in this clinical setting has been suggested. However, there is only scarce observational data on the value of this new balloon in patients with bare metal stent restenosis. This prospective, multicenter, randomized clinical trial will compare two different interventional strategies (namely, paclitaxel-eluting balloon vs everolimus-eluting stent) in the treatment of patients with bare metal stent restenosis.
Investigators
Fernando Alfonso, MD, PhD
Hospital Universitario Clínico San Carlos, Madrid. Cardiovascular Institute. Cardiac Department. Interventional Cardiology Unit
Fundación Médica para la Investigación y Desarrollo en el Area Cardiovascular
Eligibility Criteria
Inclusion Criteria
- •Age between 20 and 85 years
- •Signed informed consent
- •Acceptance of late angiographic control (6-9 months)
- •Angina and / or objective evidence of ischemia
- •In-Stent restenosis (\> 50% visual) any bare metal stent
- •Knowledge of prior stent location
Exclusion Criteria
- •Inclusion in another clinical research protocol
- •Women of childbearing age
- •Severe associated systemic disease (including renal or liver failure)
- •Severe depression of left ventricular ejection fraction (LVEF \<25%)
- •Disease that affects life expectancy
- •Recent myocardial infarction ( \<7 days)
- •Time of implantation of the previous BMS \<1 month
- •Severe difficulties expected for late angiographic study
- •Angiographic failure during implementation of initial stent(residual stenosis\> 50%)
- •Image of large thrombus in-stent (\> vessel diameter)
Outcomes
Primary Outcomes
Minimal lumen diameter
Time Frame: Late angiographic follow-up (6-9 months)
Comparison of minimal lumen diameter at late angiographic follow-up (6-9 months) between the 2 treatment strategies (by quantitative coronary angiography)
Secondary Outcomes
- Combined clinical and angiographic end-points(6-9 months, 1 year and 3 years)