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

March 12, 2015 updated by: Baylor Research Institute

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

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

93

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75230
        • Medical City Hospital
      • Plano, Texas, United States, 75093
        • The Heart Hospital Baylor Plano

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Hospital facility

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 30 days, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor Research Institute

Collaborators

Maquet Cardiovascular

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (ACTUAL)

June 1, 2014

Study Completion (ACTUAL)

June 1, 2014

Study Registration Dates

First Submitted

February 23, 2012

First Submitted That Met QC Criteria

February 27, 2012

First Posted (ESTIMATE)

February 28, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

March 17, 2015

Last Update Submitted That Met QC Criteria

March 12, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 009-177

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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