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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01540422
• Other study ID #: 009-177
• Status: Completed
• Phase: N/A
• First received: February 23, 2012
• Last updated: March 12, 2015
• Start date: October 2010
• Est. completion date: June 2014

Study information

• Verified date: March 2015
• Source: Baylor Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
United States	Medical City Hospital	Dallas	Texas
United States	The Heart Hospital Baylor Plano	Plano	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor Research Institute	Maquet Cardiovascular

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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 Sur — View Citation

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): — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improved vein graft patency	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.	Baseline and 12 months	No
Secondary	Vein graft failure	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	Baseline, 30 days, and 12 months	No