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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00292500
• Other study ID #: IP2004-06
• Status: Terminated
• Phase: N/A
• First received: February 14, 2006
• Last updated: August 19, 2013
• Start date: January 2006
• Est. completion date: December 2009

Study information

• Verified date: August 2013
• Source: Cardica, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 170
• Est. completion date: December 2009
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Automated distal anastomotic device
CABG

Locations

Country	Name	City	State
Germany	Klinik für Herzchirurgie	Leipzig

Sponsors (1)

Lead Sponsor	Collaborator
Cardica, Inc

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coronary patency of index graft at the sixth post-operative month		6 months post-op	Yes
Secondary	Establish preliminary safety profile		6 months post-op	Yes