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.

Verified February 2013 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: February 5, 2013

Last verified: February 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	February 23, 2012
Last Updated Date	February 5, 2013
Start Date ^ICMJE	October 2010
Estimated Primary Completion Date	June 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 27, 2012)	Improved vein graft patency [ Time Frame: 12 months ] [ Designated as safety issue: No ] To demonstrate improved vein graft patency at 12 months for endoscopically harested saphenous vein grafts by using modifications to existing vein harvest techniques in vein handling during harvest.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01540422 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 2, 2012)	Vein graft failure [ Time Frame: 30 days and 12 months ] [ Designated as safety issue: No ] Assess the 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 postoperative day 30 as evaluated by Coronary CT angiography Incidence of vein graft failure at postoperative Month 12 as evaluated by Coronary CT angiography Incidence of vein graft failure at each interval (30 day and 12 month) as categorized by: Harvested vessel (greater versus lesser saphenous vein) Vein graft destinations Vein graft quality
Original Secondary Outcome Measures ^ICMJE (submitted: February 27, 2012)	Vein graft failure [ Time Frame: Intra-operatively, 30 days postoperative, 12 months post-operative, 30 days and 12 months ] [ Designated as safety issue: No ] Assess the 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 postoperative day 30 as evaluated by Coronary CT angiography Incidence of vein graft failure at postoperative Month 12 as evaluated by Coronary CT angiography Incidence of vein graft failure at each interval (30 day and 12 month) as categorized by: Harvested vessel (greater versus lesser saphenous vein) Vein graft destinations Vein graft quality
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study to Improve Long Term Vein Graft Patency After Coronary Bypass Surgery by Using a Novel Endoscopic Harvesting Technique
Official Title ^ICMJE	OPTION Trial: Optimal Improvement of Vein Graft Patency Long Term by the Implementation Of Novel Endoscopic Harvesting Techniques
Brief Summary	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.
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: Intra-operatively by transit time graft flow measurements. Post-operative Day 30 through Cardiac CT Angiography. Post-operative Month 12 through Cardiac CT Angiography.
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case-Only Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Hospital facility
Condition ^ICMJE	Coronary Artery Disease
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	CABG w/saphenous vein grafts harvested using endoscopy Those who have CABG surgery with saphenous vein grafts harvested using endoscopic techniques
Publications *	Lopes RD, Hafley GE, Allen KB, Ferguson TB, Peterson ED, Harrington RA, Mehta RH, Gibson CM, Mack MJ, Kouchoukos NT, Califf RM, Alexander JH. Endoscopic versus open vein-graft harvesting in coronary-artery bypass surgery. N Engl J Med. 2009 Jul 16;361(3):235-44. Burris N, Schwartz K, Tang CM, Jafri MS, Schmitt J, Kwon MH, Toshinaga O, Gu J, Brown J, Brown E, Pierson R 3rd, Poston R. Catheter-based infrared light scanner as a tool to assess conduit quality in coronary artery bypass surgery. J Thorac Cardiovasc Surg. 2007 Feb;133(2):419-27. Epub 2006 Dec 29. Serruys PW, Morice MC, Kappetein AP, Colombo A, Holmes DR, Mack MJ, Ståhle E, Feldman TE, van den Brand M, Bass EJ, Van Dyck N, Leadley K, Dawkins KD, Mohr FW; SYNTAX Investigators. Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease. N Engl J Med. 2009 Mar 5;360(10):961-72. Epub 2009 Feb 18. Bolotin G, Kypson AP, Nifong LW, Chitwood WR Jr. A technique for evaluating competitive flow for intraoperative decision making in coronary artery surgery. Ann Thorac Surg. 2003 Dec;76(6):2118-20.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	100
Estimated Completion Date	June 2013
Estimated Primary Completion Date	June 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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: 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 dialysisdependent 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
Gender	Male
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01540422
Other Study ID Numbers ^ICMJE	009-177
Has Data Monitoring Committee	No
Responsible Party	Baylor Research Institute
Study Sponsor ^ICMJE	Baylor Research Institute
Collaborators ^ICMJE	Maquet Cardiovascular
Investigators ^ICMJE	Not Provided
Information Provided By	Baylor Research Institute
Verification Date	February 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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