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

Cardiopulmonary Research Science and Technology Institute

Status: Completed

Conditions: Coronary Artery Disease

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01697176

OPTION

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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