Optimal Improvement of Vein Graft Patency Long Term by the Implementation Of Novel Endoscopic Harvesting Techniques
OPTION
A 1-year Prospective, Multicenter, Non-Randomized, Observational, Study to Evaluate Optimal Improvement of Vein Graft Patency Long Term by the Implementation of Novel Endoscopic Harvesting Techniques
1 other identifier
observational
100
1 country
2
Brief Summary
This is an observational study of lone Coronary Artery Bypass Grafting procedures with endoscopic vein graft harvesting using best harvesting practices.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2010
Longer than P75 for all trials
2 active sites
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
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 17, 2012
CompletedFirst Posted
Study publicly available on registry
October 2, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedOctober 22, 2014
September 1, 2012
4 years
February 17, 2012
October 21, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Optimal Improvement of Vein Graft Patency Long Term by the Implementation of Novel Endoscopic Harvesting Techniques
To demonstrate improved vein graft patency rates at 12 months for endoscopically harvest saphenous vein grafts by employment of modifications to existing techniques in vein graft handling during harvests. Vein graft patency will be measured at 30 days post CABG and at one year post CABG as evaluated by cardiac CT angiography or cardiac catheterization.
12 months
Secondary Outcomes (1)
OPTION
12 months
Eligibility Criteria
Primary Isolated CABG
You may qualify if:
- Age greater than 18 and able to provide consent
- Eligible for endoscopic vein harvesting
- Minimum of two non sequential vein grafts
- Willing to comply with requirements of protocol
You may not qualify if:
- Previous CABG
- Previous or concomitant valve surgery
- Any other concomitant cardiac procedure other than surgical ablation or incidental PFO repair
- Intolerance to Iodine or IV contrast that cannot be controlled with pre-medication
- Renal insufficiency with GFR measurement ≤ 40, unless dialysis dependent
- Abnormal platelet level defined as Plt Count \>400,000
- Abnormal platelet function (hypercoagulable state) as evidenced by TEG testing
- Allergy to or presence of a condition that the investigator feels may prevent safe administration of ASA or Plavix post-operatively.
- Patient has a co-morbid condition that in the opinion of the investigator poses undue risk for successful endovascular harvesting of the vein
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
CRSTI/Medical City Dallas
Dallas, Texas, 75230, United States
The Heart Hospital Baylor Plano
Plano, Texas, 75093, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Moore, MD
The Heart Hospital Baylor Plano
- PRINCIPAL INVESTIGATOR
Michael J Mack, MD
Cardiopulmonary Research Science and Technology Institute
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2012
First Posted
October 2, 2012
Study Start
August 1, 2010
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
October 22, 2014
Record last verified: 2012-09