RIBS V (Restenosis Intra-stent of Bare Metal Stents: Paclitaxel-eluting Balloon vs Everolimus-eluting Stent)

Study Overview
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Brief Summary
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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
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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.

Official Title
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RIBS V (Restenosis Intra-stent of Bare Metal Stents: Paclitaxel-eluting Balloon vs Everolimus-eluting Stent). A Prospective, Multicenter and Randomized Clinical Trial

Conditions
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In-Stent Restenosis

Intervention / Treatment
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* Device: Coronary angioplasty using the paclitaxel-eluting balloon
* Device: Coronary angioplasty using the everolimus-eluting stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PATIENT: Age between 20 and 85 years Signed informed consent Acceptance of late angiographic control (6-9 months) Angina and / or objective evidence of ischemia LESION: In-Stent restenosis (> 50% visual) any bare metal stent Knowledge of prior stent location Exclusion Criteria: PATIENT: 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 LESION: Angiographic failure during implementation of initial stent(residual stenosis> 50%) Image of large thrombus in-stent (> vessel diameter) Tortuosity or Ca + + with very severe difficulties during prior stent deployment Vessel diameter <2 mm (visual estimate) Restenosis only outside the stent (The edge of the stent is not affected) Completely occlusive restenosis (100%, TIMI 0) Very diffuse restenosis (> 30 mm length)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Paclitaxel-eluting balloon<br>Paclitaxel-eluting balloon (SeQuent Please, B. Braun) | Device: Coronary angioplasty using the paclitaxel-eluting balloon<br>* Balloon angioplasty<br>|
| Active Comparator: Everolimus-eluting stent<br>Everolimus-eluting stent (Xience Prime, Abbott Vascular) | Device: Coronary angioplasty using the everolimus-eluting stent<br>* Stent implantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal lumen diameter | Comparison of minimal lumen diameter at late angiographic follow-up (6-9 months) between the 2 treatment strategies (by quantitative coronary angiography) | Late angiographic follow-up (6-9 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined clinical and angiographic end-points | A) Efficacy outcomes: A1) Angiographic: 1) Restenosis rate, 2) % diameter stenosis, 3) acute gain, 4) late loss, 5) net gain A2) Composite of death, myocardial infarction, target vessel revascularization and analysis of individual events B) Safety Outcomes: Stent thrombosis, Bleeding episodes. C) Pre-specified variables for subgroup analysis (RIBS I) D) Stratification (length and edge). Type of stent E) Influence of clinical variables and restenosis patterns on outcome | 6-9 months, 1 year and 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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In-stent restenosis, Drug-eluting balloon, Drug-eluting stent, Angiography, Minimal lumen diameter