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

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

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.

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.

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)