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

NCT ID: NCT01697176

Last Updated: 2014-10-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2014-08-31

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.

Conditions

Coronary Artery Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maquet Cardiovascular

INDUSTRY

Sponsor Role: collaborator

Cardiopulmonary Research Science and Technology Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Moore, MD

Role: PRINCIPAL_INVESTIGATOR

The Heart Hospital Baylor Plano

Michael J Mack, MD

Role: PRINCIPAL_INVESTIGATOR

Cardiopulmonary Research Science and Technology Institute

Locations

CRSTI/Medical City Dallas

Dallas, Texas, United States

The Heart Hospital Baylor Plano

Plano, Texas, United States

Countries

United States

Other Identifiers

OPTION

Identifier Type: -

Identifier Source: org_study_id