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

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

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

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease

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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Primary Isolated CABG

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Optimal Improvement of Vein Graft Patency Long Term by the Implementation of Novel Endoscopic Harvesting Techniques	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OPTION	To develop a standardized approach for harvesting, handling and preparing vein grafts in the endoscopic approach. By capturing the following: Incidence of vein graft failure at the time of initial CABG as evaluated by transit time graft flow measurements; Incidence of vein graft failure at post-operative day 30 as evaluated by cardiac CT angiography or cardiac catheterization; Incidence of vein graft failure at each interval (30 day and 12 month) as categorized by:Harvested vesselvein graft destinationsvein graft quality	12 months

Collaborators and Investigators

• Sponsor: Cardiopulmonary Research Science and Technology Institute
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: February 17, 2012
• First Submitted That Met QC Criteria: September 28, 2012
• First Posted (Estimate): October 2, 2012

Study Record Updates

• Last Update Posted (Estimate): October 22, 2014
• Last Update Submitted That Met QC Criteria: October 21, 2014
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: OPTION