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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Cardiopulmonary Research Science and Technology Institute.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Maquet Cardiovascular
Information provided by (Responsible Party):
Cardiopulmonary Research Science and Technology Institute
ClinicalTrials.gov Identifier:
NCT01697176
First received: February 17, 2012
Last updated: September 28, 2012
Last verified: September 2012
  Purpose

This is an observational study of lone Coronary Artery Bypass Grafting procedures with endoscopic vein graft harvesting using best harvesting practices.


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official 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

Resource links provided by NLM:


Further study details as provided by Cardiopulmonary Research Science and Technology Institute:

Primary Outcome Measures:
  • Optimal Improvement of Vein Graft Patency Long Term by the Implementation of Novel Endoscopic Harvesting Techniques [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • OPTION [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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

    1. 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 post-operative day 30 as evaluated by cardiac CT angiography or cardiac catheterization
    3. Incidence of vein graft failure at each interval (30 day and 12 month) as categorized by:

      1. Harvested vessel
      2. vein graft destinations
      3. vein graft quality


Estimated Enrollment: 100
Study Start Date: August 2010
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

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

Primary Isolated CABG

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
  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: NCT01697176

Locations
United States, Texas
CRSTI/Medical City Dallas Recruiting
Dallas, Texas, United States, 75230
Contact: Michelle Powell    972-566-6820      
The Heart Hospital Baylor Plano Recruiting
Plano, Texas, United States, 75093
Contact: Natalie Settele, MD    469-814-4712      
Sponsors and Collaborators
Cardiopulmonary Research Science and Technology Institute
Maquet Cardiovascular
Investigators
Principal Investigator: David Moore, MD The Heart Hospital Baylor Plano
Principal Investigator: Michael J Mack, MD Cardiopulmonary Research Science and Technology Institute
  More Information

No publications provided

Responsible Party: Cardiopulmonary Research Science and Technology Institute
ClinicalTrials.gov Identifier: NCT01697176     History of Changes
Other Study ID Numbers: OPTION
Study First Received: February 17, 2012
Last Updated: September 28, 2012
Health Authority: United States: Institutional Review Board

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 September 16, 2014