Efficacy of Automated Distal Vascular Anastomosis in Coronary Surgery: Phase II

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of Automated Distal Vascular Anastomosis in Coronary Surgery: Phase II

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Automated distal anastomotic device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: C-Port<br>Automated distal anastomotic device | Device: Automated distal anastomotic device<br>* CABG<br>* Other names: C-Port xA Distal Anastomosis System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coronary patency of index graft at the sixth post-operative month |  | 6 months post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establish preliminary safety profile |  | 6 months post-op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CABG, anastomotic device; myocardial revascularization