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

Cardica, Inc170 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

170

Conditions

Coronary Artery Disease

Interventions

Automated distal anastomotic deviceDEVICE

CABG

Eligibility

Sex: ALLMin age: 50 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Klinik für Herzchirurgie

Leipzig, Germany

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

Time frame: 6 months post-op

Data from ClinicalTrials.gov

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