Study of Endoscopic Versus Open Harvest of the Radial Artery in Coronary Artery Bypass Surgery

This study has been completed.
Sponsor:
Collaborator:
Johnson & Johnson
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00303706
First received: March 15, 2006
Last updated: September 27, 2007
Last verified: September 2007
  Purpose

The purpose of this study is to compare the safety and effectiveness of minimally invasive endoscopic harvest of the radial artery to the conventional open method of radial artery harvest in coronary artery bypass surgery. The researchers hypothesize that the radial artery can be safely, efficiently, and routinely harvested using a minimally invasive endoscopic technique. Endoscopic minimally invasive harvesting of the radial artery will reduce the postoperative morbidity due to pain, wound infection, and neurological complications and improve cosmetic results.


Condition Intervention Phase
Coronary Artery Disease
Procedure: Endoscopic Radial Artery Harvest
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Randomized Trial of Endoscopic Versus Conventional Harvesting of the Radial Artery in Coronary Artery Bypass

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • The primary outcome event will be the rate of forearm wound infection at 6 weeks. [ Time Frame: 6 weeks ]

Secondary Outcome Measures:
  • Wound pain [ Time Frame: 6 weeks ]
  • Neurological complications [ Time Frame: 6 weeks ]
  • Patient satisfaction [ Time Frame: 6 weeks ]
  • Length of hospitalization [ Time Frame: will vary with patient lenght of stay ]
  • Histological integrity of the harvested radial artery [ Time Frame: during OR ]

Enrollment: 119
Study Start Date: April 2005
Study Completion Date: August 2007
Detailed Description:

Many surgical disciplines have been quick to adopt minimally invasive techniques because of decreased complications and shorter recovery times. As we enter the fifth decade of coronary artery bypass grafting surgery more attempts are being made to perform the operation less invasively. Harvesting of the saphenous vein (a large superficial vein in the leg which is routinely used in bypass surgery) using a telescope (camera), has been shown to be superior to harvesting the vein through a large open incision. At our institution, this vein mentioned above, is routinely harvested using less invasive techniques with a camera. This has been shown to result in less infection.

In the early 1990's, the radial artery was reintroduced into bypass surgery to increase the number of available alternative bypass grafts. Long-term results of the radial artery (8-9 years) have shown that 88-91% of the radial arteries harvested remain open thereby allowing the flow of blood. This is significantly better than the 10-year rates of the saphenous vein of 53-67%. Therefore, the radial artery has become more popular as a bypass graft.

Conventionally, the radial artery is harvested by making a long vertical incision extending from the wrist to the elbow. The radial artery is then dissected under direct vision within this large open incision. Complications from the open harvest of the radial artery include infection, neurological complications, possible decrease blood flow to the hand, and poor wound healing or scarring.

Recently, with the development of endoscopic harvesting systems, the radial artery can be harvested using a telescope (camera) and very small incisions. Thus far, to our knowledge there have been no published studies comparing conventional techniques to less invasive endoscopic techniques for harvesting the radial artery. Therefore, we propose a prospective randomized study to determine if the radial artery can be routinely harvested using an endoscopic minimally invasive technique. We wish to compare the conventional open technique to the minimally invasive technique to determine if there are any differences in postoperative complications, length of hospital stay or possible differences in patient satisfaction in cosmetic results (scarring) between the two techniques.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eligible patients greater than 18 years of age with coronary artery disease requiring elective, urgent, or emergency coronary artery revascularization where the radial artery can be used as a bypass conduit.

Exclusion Criteria:

  • Patient's refusal to have surgery, inability to give informed consent, and contraindication in harvesting the radial artery.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00303706

Locations
Canada, Ontario
London Health Sciences Centre, University Hospital
London, Ontario, Canada, N6A 5A5
Sponsors and Collaborators
Lawson Health Research Institute
Johnson & Johnson
Investigators
Principal Investigator: Bob Kiaii, MD, FRCSC Department of Cardiac Surgery, University of Western Ontario and the London Health Sciences Centre, University Hospital
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00303706     History of Changes
Other Study ID Numbers: R-05-053
Study First Received: March 15, 2006
Last Updated: September 27, 2007
Health Authority: Canada: Health Canada

Keywords provided by Lawson Health Research Institute:
CABG, Endoscopic, Radial Artery
Radial Artery Conduit
Coronary Artery Bypass Surgery
Endoscopic technique

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 29, 2014