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OpenTrials
Completed

NCT Number: NCT01697176

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CRSTI/Medical City Dallas, Dallas, Texas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 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 outcomes

  1. OPTION

    Time frame: 12 months

    To develop a standardized approach for harvesting, handling and preparing vein grafts in the endoscopic approach. By capturing the following:

    • Incidence of vein graft failure at the time of initial CABG as evaluated by transit time graft flow measurements
    • Incidence of vein graft failure at post-operative day 30 as evaluated by cardiac CT angiography or cardiac catheterization
    • Incidence of vein graft failure at each interval (30 day and 12 month) as categorized by:
    • Harvested vessel
    • vein graft destinations
    • vein graft quality

Sponsors and collaborators

Lead sponsor

Cardiopulmonary Research Science and Technology Institute

Other

Collaborators

  • Maquet Cardiovascular

Registry information

Official study title

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

Acronym: OPTION

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Oct 2, 2012
Registry last updated
Oct 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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