RIBS IV (Restenosis Intra-stent of Drug-eluting 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 paclitaxel-eluting balloon

Device: Coronary angioplasty using the Everolimus-eluting stent

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01239940

RIBS IV

Details and patient eligibility

About

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.

Full 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.

Enrollment

310 estimated 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 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)