NCT01540422

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2010

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 23, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 28, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

March 17, 2015

Status Verified

March 1, 2015

Enrollment Period

3.7 years

First QC Date

February 23, 2012

Last Update Submit

March 12, 2015

Conditions

Coronary Artery Disease

Keywords

vein graftscoronary bypassendoscopic harvestendoscopic vein harvest

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Vein graft failure

    Baseline, 30 days, and 12 months

Study Arms (1)

CABG w/saphenous vein grafts harvested using endoscopy

Those who have CABG surgery with saphenous vein grafts harvested using endoscopic techniques

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospital facility

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medical City Hospital

Dallas, Texas, 75230, United States

Location

The Heart Hospital Baylor Plano

Plano, Texas, 75093, United States

Location

Related 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. doi: 10.1016/s0003-4975(03)00652-0.

    PMID: 14667667BACKGROUND

  • 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. doi: 10.1056/NEJMoa0900708.

    PMID: 19605828RESULT

  • 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. doi: 10.1016/j.jtcvs.2006.09.056. Epub 2006 Dec 29.

    PMID: 17258576RESULT

  • Serruys PW, Morice MC, Kappetein AP, Colombo A, Holmes DR, Mack MJ, Stahle 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. doi: 10.1056/NEJMoa0804626. Epub 2009 Feb 18.

    PMID: 19228612RESULT

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2012

First Posted

February 28, 2012

Study Start

October 1, 2010

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

March 17, 2015

Record last verified: 2015-03

Locations

US(2)