Optimal Improvement of Vein Graft Patency Long Term by the Implementation Of Novel Endoscopic Harvesting Techniques



Status:Completed
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:11/8/2014
Start Date:August 2010
End Date:August 2014

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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

This is an observational study of lone Coronary Artery Bypass Grafting procedures with
endoscopic vein graft harvesting using best harvesting practices.

This is a prospective, multi-center, non-randomized, observational study of 100 patients who
will undergo routine coronary artery bypass grafting. Eligible candidates will undergo lone
Coronary Artery Bypass Graft (CABG) procedures with endoscopic vein harvesting using best
harvesting practices, defined as: systemic heparinization prior to vein manipulation,
standardization of vein graft harvesting techniques, pressure limiting syringe and 3 month
use of dual anti-platelet therapy. Patients will undergo a CT angiography at 30 days and 12
months to assess vein graft patency.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
2
sites
Dallas, Texas 75230
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Dallas, TX
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Plano, Texas 75093
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Plano, TX
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