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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01697176
First Posted: October 2, 2012
Last Update Posted: October 22, 2014
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.
Collaborator:
Maquet Cardiovascular
Information provided by (Responsible Party):
Cardiopulmonary Research Science and Technology Institute
  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 ]
    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 ]

    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


Enrollment: 100
Study Start Date: August 2010
Study Completion Date: August 2014
Primary Completion Date: August 2014 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT01697176


Locations
United States, Texas
CRSTI/Medical City Dallas
Dallas, Texas, United States, 75230
The Heart Hospital Baylor Plano
Plano, Texas, United States, 75093
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

Responsible Party: Cardiopulmonary Research Science and Technology Institute
ClinicalTrials.gov Identifier: NCT01697176     History of Changes
Other Study ID Numbers: OPTION
First Submitted: February 17, 2012
First Posted: October 2, 2012
Last Update Posted: October 22, 2014
Last Verified: September 2012

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