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

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT01697176
• Lead Sponsor: Cardiopulmonary Research Science and Technology Institute

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.

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2012-02-17
• Status Verified: 2012-09
• Study First Submitted QC: 2012-09-28
• Study First Posted: 2012-10-02
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Last Update Submitted: 2014-10-21
• Last Update Posted: 2014-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

CRSTI/Medical City Dallas; 🇺🇸 Dallas, Texas, United States

The Heart Hospital Baylor Plano; 🇺🇸 Plano, Texas, United States