RIBS IV (Restenosis Intra-stent of Drug-eluting Stents: Paclitaxel-eluting Balloon vs Everolimus-eluting Stent)

Study Overview
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Brief Summary
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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
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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.

Official Title
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RIBS IV (Restenosis Intra-stent of Drug-eluting 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 drug-eluting 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 DES <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 and eluted drug 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