Phase
Condition
Atherosclerosis
Treatment
N/AClinical Study ID
Ages 21-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Randomized Cohort: Requires CABG surgery with a SVG to the right coronary artery (RCA)system AND the left circumflex artery (LCX) system with a ≥ 70% stenosis in each ofthe two systems.
Single Vessel Cohort: Requires CABG surgery with a SVG to the RCA system or the LCXsystem with a > 70% stenosis in the system.
Medial sternotomy with cardiopulmonary bypass (CPB) during surgery.
Both saphenous vein graft length are adequate for planned intervention, vein outerdiameter is between 3.6 mm and 7.0 mm and double wall thickness less than 1.4 mm.
Agreement to post-procedure follow-up contact and testing (including follow-upcoronary angiogram).
Exclusion
Exclusion Criteria:
Concomitant non-CABG cardiac procedure.
Prior cardiac surgery (does not include percutaneous procedures).
Cerebrovascular or transient ischemia attack within 30 days of the CABG procedure.
Age > 85 years.
Left ventricular ejection fraction ≤ 35%.
Creatinine > 133 μmol/L (1.5 mg/dL) prior to CABG procedure or on chronic dialysis.
STEMI within 7 days or total CK > 2 times the upper limit of normal prior to the CABGprocedure.
Both enrolled grafts will feed non-viable myocardial territory.
Diffuse atherosclerotic disease (> 70%) distal to either of the enrolled targetcoronary arteries.
Randomized Cohort: By visual estimate, the target coronary artery diameter of both theright coronary system and left circumflex system must be within 1.5mm of each other.
Planned endarterectomy of the target coronary artery.
Study Design
Connect with a study center
General University Hospital
Prague,
Czech RepublicActive - Recruiting
Hospital na Homolce
Prague,
Czech RepublicActive - Recruiting
University Hospital Kralovske Vinohrady
Prague,
Czech RepublicSite Not Available
C.H.U. Dupuytren
Limoges,
FranceActive - Recruiting
Bordeaux University Hospital
Pessac,
FranceActive - Recruiting
Brothers of Mercy Hospital
Trier,
GermanySite Not Available
Lancisi Hospital
Ancona,
ItalyActive - Recruiting
Heart Hospital - G. Monasterio Tuscany Foundation for Health & Research
Massa,
ItalyActive - Recruiting
Catharina Ziekenhuis
Eindhoven,
NetherlandsActive - Recruiting
University Hospital of Bern
Bern, 3010
SwitzerlandActive - Recruiting
Royal Brompton Hospital
London, SW3 6NP
United KingdomActive - Recruiting
Emory University Hospital Midtown
Atlanta, Georgia 30308
United StatesActive - Recruiting
Northeast Georgia Heart Center
Gainesville, Georgia 30501
United StatesActive - Recruiting
Mayo Clinic / St. Mary's Hospital
Rochester, Minnesota 55905
United StatesActive - Recruiting
The Valley Hospital
Ridgewood, New Jersey 07450
United StatesActive - Recruiting
Lenox Hill Hospital
New York, New York 10075
United StatesActive - Recruiting
Cleveland Clinic
Cleveland, Ohio 44195
United StatesSite Not Available
St. Luke's Hospital / Texas Heart Institute
Houston, Texas 77030
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.