Status:
UNKNOWN
RIBS IV (Restenosis Intra-stent of Drug-eluting Stents: Paclitaxel-eluting Balloon vs Everolimus-eluting Stent)
Lead Sponsor:
Fundación Médica para la Investigación y Desarrollo en el Area Cardiovascular
Collaborating Sponsors:
Hospital San Carlos, Madrid
B.Braun Surgical SA
Conditions:
In-stent Restenosis
Eligibility:
All Genders
20-85 years
Phase:
PHASE4
Brief Summary
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 ...
Detailed 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,...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
310 Patients enrolled
Trial Details
Trial ID
NCT01239940
Start Date
January 1 2010
Last Update
June 27 2011
Active Locations (25)
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1
Complejo Hospitalario Universitario A Coruña
A Coruña, A Coruña, Spain, 15006
2
Hospital General Universitario de Alicante
Alicante, Alicante, Spain, 03010
3
Complejo Hospitalario de Torrecardenas
Almería, Almeria, Spain, 04009
4
Hospital Universitario Infanta Cristina
Badajoz, Badajoz, Spain, 06080