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

Cardica

Status

Terminated

Conditions

Coronary Artery Disease

Treatments

Device: Automated distal anastomotic device

Study type

Interventional

Funder types

Industry

Identifiers

NCT00292500

IP2004-06

Details and patient eligibility

About

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.

Full 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.

Enrollment

170 patients

Sex

All

Ages

50 to 85 years old

Volunteers

No Healthy Volunteers

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