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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00292500

Enrollment

170

Registered

2006-02-16

Start date

2006-01-31

Completion date

2009-12-31

Last updated

2013-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

CABG, anastomotic device; myocardial revascularization

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.

Interventions

DEVICEAutomated distal anastomotic device

CABG

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame
Coronary patency of index graft at the sixth post-operative month	6 months post-op

Secondary

Measure	Time frame
Establish preliminary safety profile	6 months post-op

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026