Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
120 participants
INTERVENTIONAL
2012-08-31
2020-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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eSVS Mesh treated saphenous vein graft
Each subject will be randomized to an eSVS Mesh treated SVG to the right or left coronary system.
eSVS Mesh treated saphenous vein graft
During coronary artery bypass graft surgery, one SVG will be randomized to be treated with eSVS Mesh and implanted in the right or left coronary system.
Control saphenous vein graft
Each subject will be randomized to an untreated (no eSVS Mesh) SVG to the right or left coronary system.
Control saphenous vein graft
During coronary artery bypass graft surgery, one SVG will be randomized to be the control (no eSVS Mesh) and implanted in the right or left coronary system.
Single Vessel Treatment
Each subject with receive one SVG with eSVS Mesh either to the right or left coronary system.
eSVS Mesh treated saphenous vein graft
During coronary artery bypass graft surgery, one SVG will be randomized to be treated with eSVS Mesh and implanted in the right or left coronary system.
Interventions
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eSVS Mesh treated saphenous vein graft
During coronary artery bypass graft surgery, one SVG will be randomized to be treated with eSVS Mesh and implanted in the right or left coronary system.
Control saphenous vein graft
During coronary artery bypass graft surgery, one SVG will be randomized to be the control (no eSVS Mesh) and implanted in the right or left coronary system.
Eligibility Criteria
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Inclusion Criteria
* Single Vessel Cohort: Requires CABG surgery with a SVG to the RCA system or the LCX system 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 outer diameter 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-up coronary angiogram).
Exclusion Criteria
* 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 CABG procedure.
* Both enrolled grafts will feed non-viable myocardial territory.
* Diffuse atherosclerotic disease (\> 70%) distal to either of the enrolled target coronary arteries.
* Randomized Cohort: By visual estimate, the target coronary artery diameter of both the right coronary system and left circumflex system must be within 1.5mm of each other.
* Planned endarterectomy of the target coronary artery.
21 Years
85 Years
ALL
No
Sponsors
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Kips Bay Medical, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Lars Englberger, MD
Role: PRINCIPAL_INVESTIGATOR
University of Bern
John Puskas, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Emory University Hospital Midtown
Atlanta, Georgia, United States
Northeast Georgia Heart Center
Gainesville, Georgia, United States
Mayo Clinic / St. Mary's Hospital
Rochester, Minnesota, United States
The Valley Hospital
Ridgewood, New Jersey, United States
Lenox Hill Hospital
New York, New York, United States
General University Hospital
Prague, , Czechia
Hospital na Homolce
Prague, , Czechia
University Hospital Kralovske Vinohrady
Prague, , Czechia
C.H.U. Dupuytren
Limoges, , France
Bordeaux University Hospital
Pessac, , France
Lancisi Hospital
Ancona, , Italy
Heart Hospital - G. Monasterio Tuscany Foundation for Health & Research
Massa, , Italy
Catharina Ziekenhuis
Eindhoven, , Netherlands
University Hospital of Bern
Bern, , Switzerland
Royal Brompton Hospital
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Kimberly Michel, RN
Role: primary
Nirav Patel, MD
Role: primary
Jaroslav Lindner, MD
Role: primary
Ivo Skalsky, MD
Role: primary
Giuseppe Rescigno, MD
Role: primary
Other Identifiers
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11016
Identifier Type: -
Identifier Source: org_study_id
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