Study to Improve Long Term Vein Graft Patency After Coronary Bypass Surgery by Using a Novel Endoscopic Harvesting Technique

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01540422
Recruitment Status : Completed
First Posted : February 28, 2012
Last Update Posted : March 17, 2015
Maquet Cardiovascular
Information provided by (Responsible Party):
Baylor Research Institute

Brief Summary:
The purpose of this study is to demonstrate improved vein graft patency rates at 12 months for endoscopically harvested saphenous vein grafts. The study will evaluate use modifications to existing techniques in vein graft handling during harvests. A secondary aim is to develop a standardized approach for harvesting, handling, and preparing vein grafts in the endoscopic approach.

Condition or disease
Coronary Artery Disease

Detailed Description:

Available data supports two facts: 1) Saphenous vein graft failure rates may be as high as 47% per patient at one year post coronary artery bypass grafting, and 2) Endoscopic vein-graft harvesting is independently associated with vein-graft failure and adverse clinical outcomes.

Multiple factors may contribute to the lower long term patency rates of endoscopically harvested grafts. Summarized, the two major contributing factors are theorized to be harvesting techniques and vein trauma during harvesting.

With recognized disadvantages of open vessel harvesting including higher incidence of infection, longer incisions, greater potential for poor healing, and longer length of hospital stay, reducing the failure rate of vein grafts harvested endoscopically is of utmost importance.

It is our hypothesis that modification of existing harvesting techniques can improve vein graft patency in endoscopic vein graft harvesting so that patency rates comparable to open vessel harvesting can be obtained.

In this prospective, multi-center non-randomized, observational study, 100 patients will undergo routine coronary artery bypass grafting. Eligible candidates will undergo lone coronary artery bypass graft (CABG) procedures with endoscopic vein graft harvesting using best harvesting practices. As a part of routine postoperative care, patients will be prescribed dual-antiplatelet therapy of aspirin and clopidogrel. Compliance with 3 months of dual-antiplatelet therapy will be monitored.

Vein graft patency will be evaluated:

  1. Intra-operatively by transit time graft flow measurements.
  2. Post-operative Day 30 through Cardiac CT Angiography.
  3. Post-operative Month 12 through Cardiac CT Angiography.

Study Type : Observational
Actual Enrollment : 93 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: OPTION Trial: Optimal Improvement of Vein Graft Patency Long Term by the Implementation Of Novel Endoscopic Harvesting Techniques
Study Start Date : October 2010
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

CABG w/saphenous vein grafts harvested using endoscopy
Those who have CABG surgery with saphenous vein grafts harvested using endoscopic techniques

Primary Outcome Measures :
  1. Improved vein graft patency [ Time Frame: Baseline and 12 months ]
    To demonstrate improved vein graft patency at 12 months for endoscopically harvested saphenous vein grafts by using modifications to existing vein harvest techniques in vein handling during harvest.

Secondary Outcome Measures :
  1. Vein graft failure [ Time Frame: Baseline, 30 days, and 12 months ]
    1. Assess the 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 postoperative day 30 as evaluated by Coronary CT angiography
    3. Incidence of vein graft failure at postoperative Month 12 as evaluated by Coronary CT angiography
    4. Incidence of vein graft failure at each interval (30 day and 12 month) as categorized by:

      1. Harvested vessel (greater versus lesser saphenous vein)
      2. Vein graft destinations
      3. Vein graft quality

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospital facility

Inclusion Criteria:

  • Males and females at least 18 years of age and able to sign consent
  • Undergoing CABG surgery
  • Eligible for endoscopic saphenous vein harvesting
  • A minimum of two non-sequential vein grafts will be performed
  • Subject willing to comply with the requirements of the protocol

Exclusion Criteria:

  1. Previous CABG
  2. Previous or concomitant valve surgery
  3. Any other concomitant cardiac procedure other than surgical ablation or incidental PFO repair
  4. Intolerance to Iodine or IV contrast that cannot be controlled with pre-medication
  5. Renal insufficiency with GFR measurement ≤ 40, unless dialysis dependent
  6. Abnormal platelet level defined as Plt Count >400,000
  7. Abnormal platelet function (hypercoagulable state) as evidenced by TEG testing
  8. Allergy to or presence of a condition that the investigator feels may prevent safe administration of ASA or Plavix post-operatively.
  9. Patient has a co-morbid condition that in the opinion of the investigator poses undue risk for successful endovascular harvesting of the vein

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01540422

United States, Texas
Medical City Hospital
Dallas, Texas, United States, 75230
The Heart Hospital Baylor Plano
Plano, Texas, United States, 75093
Sponsors and Collaborators
Baylor Research Institute
Maquet Cardiovascular

Publications of Results:
Other Publications:
Responsible Party: Baylor Research Institute Identifier: NCT01540422     History of Changes
Other Study ID Numbers: 009-177
First Posted: February 28, 2012    Key Record Dates
Last Update Posted: March 17, 2015
Last Verified: March 2015

Keywords provided by Baylor Research Institute:
vein grafts
coronary bypass
endoscopic harvest
endoscopic vein harvest

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases