RIBS IV (Restenosis Intra-stent of Drug-eluting 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
- 310
- Locations
- 25
- Primary Endpoint
- Minimal lumen diameter
- Last Updated
- 14 years ago
Overview
Brief Summary
Treatment of patients with drug-eluting 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 drug-eluting stent restenosis.
Detailed Description
Treatment of patients with drug-eluting 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 drug-eluting 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 drug-eluting stent restenosis.
Investigators
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 drug-eluting 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 DES \<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)