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

Coronary Artery Disease Clinical Trial

— OPTION  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01697176
• Other study ID #: OPTION
• Status: Completed
• Phase: N/A
• First received: February 17, 2012
• Last updated: October 21, 2014
• Start date: August 2010
• Est. completion date: August 2014

Study information

• Verified date: September 2012
• Source: Cardiopulmonary Research Science and Technology Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Cardiopulmonary Research Science and Technology Institute	Maquet Cardiovascular

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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 vessel; vein graft destinations; vein graft quality	12 months	No