Status:
TERMINATED
Assessment of Revascularization Versus Conservative Treatment in Heart Transplant Patients for a Clinical Event Reduction
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Heart-lung Transplant Rejection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The aim of the study is to compare optimal medical therapy alone versus percutaneous coronary intervention on top of medical therapy in the setting of heart transplant recipient coronary artery diseas...
Detailed Description
The hypothesis of the study is the superiority of the interventional management over medical therapy alone in preventing the occurrence of the primary endpoint of the study assessed 1 year after rando...
Eligibility Criteria
Inclusion
- Patients ≥ 18 years old
- Heart transplant recipient
- Stable clinical situation
- One or several non-critical coronary stenoses (≥ 50% et ≤ 75% visually or QCA-assessed diameter stenosis) considered as adequate for coronary stenting by the operator
- Left ventricular ejection fraction ≥ 40%
- Informed consentement signed by the patient
Exclusion
- Acute coronary syndrome
- In-stent restenosis
- Proof of an extensive myocardial ischemia (≥ 7/17 segments ASE model)
- Coronary stenosis considered as critical by the operators with slow flow
- ACC/AHA Class IA indication for revascularization :
- vessel disease with left ventricular dysfunction
- Left main stenosis
- Severe proximal LAD stenosis
- Contra-indication to dual antiplatelet therapy
- Decompensated heart failure at the time of randomization
- Pregnant or breast-feeding women- Patients participating to another clinical research within 30 days before randomization- life expectancy \< 1 y
- Patients unable to observe strict medical therapy and follow-up within 1 year after randomization
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01795729
Start Date
February 1 2013
End Date
February 1 2015
Last Update
October 14 2015
Active Locations (1)
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1
Pitié Salpetriere university Hospital - Cardiology
Paris, France, 75013