Study Stopped
Cardica has terminated the development of the product for Business Reason.
Efficacy of Automated Distal Vascular Anastomosis in Coronary Surgery: Phase II
1 other identifier
interventional
170
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable coronary-artery-disease
Started Jan 2006
Typical duration for not_applicable coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 14, 2006
CompletedFirst Posted
Study publicly available on registry
February 16, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedAugust 21, 2013
August 1, 2013
2.8 years
February 14, 2006
August 19, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Coronary patency of index graft at the sixth post-operative month
6 months post-op
Secondary Outcomes (1)
Establish preliminary safety profile
6 months post-op
Study Arms (1)
C-Port
NO INTERVENTIONAutomated distal anastomotic device
Interventions
CABG
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cardica, Inclead
Study Sites (1)
Klinik für Herzchirurgie
Leipzig, D-04289, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jan Gummert, MD
Herzzentrum Leipzig Gmbh
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2006
First Posted
February 16, 2006
Study Start
January 1, 2006
Primary Completion
October 1, 2008
Study Completion
December 1, 2009
Last Updated
August 21, 2013
Record last verified: 2013-08