Coronary Artery Disease
Conditions
Brief summary
This is an observational study of lone Coronary Artery Bypass Grafting procedures with endoscopic vein graft harvesting using best harvesting practices.
Detailed description
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.
Interventions
None listed
Sponsors
Maquet Cardiovascular
Cardiopulmonary Research Science and Technology Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Optimal Improvement of Vein Graft Patency Long Term by the Implementation of Novel Endoscopic Harvesting Techniques | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OPTION | 12 months | To develop a standardized approach for harvesting, handling and preparing vein grafts in the endoscopic approach. By capturing the following: 1. Incidence of vein graft failure at the time of initial CABG as evaluated by transit time graft flow measurements 2. Incidence of vein graft failure at post-operative day 30 as evaluated by cardiac CT angiography or cardiac catheterization 3. Incidence of vein graft failure at each interval (30 day and 12 month) as categorized by: 1. Harvested vessel 2. vein graft destinations 3. vein graft quality |
Countries
United States
Outcome results
None listed