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

Fundación Médica para la Investigación y Desarrollo en el Area Cardiovascular

Status and phase

Unknown

Phase 4

Conditions

In-Stent Restenosis

Treatments

Device: Coronary angioplasty using the everolimus-eluting stent

Device: Coronary angioplasty using the paclitaxel-eluting balloon

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01239953

RIBS V

Details and patient eligibility

About

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.

Full 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.

Enrollment

190 patients

Sex

All

Ages

20 to 85 years old

Volunteers

No Healthy Volunteers

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)