Efficacy of Automated Distal Vascular Anastomosis in Coronary Surgery: Phase II
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 170
- Locations
- 2
- Primary Endpoint
- Coronary patency of index graft at the sixth post-operative month
Study Overview
Brief Summary
This evaluation is designed to evaluate the feasibility of using an automated distal coronary anastomotic to facilitate grafting of the left internal mammary artery to the left anterio descending coronary artery during myocardial revascularization in patients with coronary artery disease requiring surgical intervention. The study is designed to assess the ability to compare the patency of grafts created using an automated device versus hand-sewn grafts of the same vessels in the same patient population.
Detailed Description
Evaluation of automated distal anastomotic device as a surrogate for hand-sewn grafts for completion of arterial conduit anastomosis between the Left Internal Mammary Artery and Left Anterior Descending Artery among patients with coronary artery disease requiring surgical revascularization.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age between 50 and 85 years (inclusive)
- •Diagnostically confirmed coronary disease
- •Ejection fraction > 30%
- •Tolerate contrast media
- •Acceptable LIMA (conduit) and LAD (target)for grafting
- •Life expectancy > 1 year
Exclusion Criteria
- •Refusal to give informed consent
- •Unable to meet study travel and general health requirements
- •Pregnancy
- •Previous cardiac surgery
- •NYHA Class IV
- •Preoperative need for IABP
- •Acute or chronic dialysis (creatinine > 200mmolor 2.3 mg/dL) within 30 days of surgery
- •Acute or suspected systemic infection
- •Need for ongoing immunosuppressive therapy
- •Recent history (<2 weeks) of CVA
- •Aspirin allergy
Outcomes
Primary Outcomes
Coronary patency of index graft at the sixth post-operative month
Time Frame: 6 months post-op
Secondary Outcomes
- Establish preliminary safety profile(6 months post-op)