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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Baylor Research Institute
Sponsor:
Collaborator:
Maquet Cardiovascular
Information provided by (Responsible Party):
Baylor Research Institute
ClinicalTrials.gov Identifier:
NCT01540422
First received: February 23, 2012
Last updated: April 21, 2014
Last verified: April 2014
  Purpose

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
Coronary Artery Disease

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Baylor Research Institute:

Primary Outcome Measures:
  • Improved vein graft patency [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    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:
  • Vein graft failure [ Time Frame: Baseline, 30 days, and 12 months ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 100
Study Start Date: October 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
CABG w/saphenous vein grafts harvested using endoscopy
Those who have CABG surgery with saphenous vein grafts harvested using endoscopic techniques

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hospital facility

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01540422

Locations
United States, Texas
Medical City Hospital Recruiting
Dallas, Texas, United States, 75230
Contact: Claudia Mattil    469-814-4712    claudia.mattil@baylorhealth.edu   
Contact: Michael Johnson    469-814-4734    michael.johnson@baylorhealth.edu   
Principal Investigator: David O Moore, MD         
Sub-Investigator: Robert L Smith, MD         
Sub-Investigator: Michael Mack, MD         
Sub-Investigator: William L Brinkman, MD         
The Heart Hospital Baylor Plano Recruiting
Plano, Texas, United States, 75093
Contact: Claudia Mattil    459-814-4712    Claudia.Mattil@baylorhealth.edu   
Contact: Michael Johnson    469-814-4734    Michael.Johnson@baylorhealth.edu   
Principal Investigator: David o Moore, MD         
Sub-Investigator: Robert L Smith, MD         
Sub-Investigator: Michael Mack, MD         
Sub-Investigator: William L Brinkman, MD         
Sponsors and Collaborators
Baylor Research Institute
Maquet Cardiovascular
  More Information

Publications:
Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT01540422     History of Changes
Other Study ID Numbers: 009-177
Study First Received: February 23, 2012
Last Updated: April 21, 2014
Health Authority: United States: Institutional Review Board

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
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014