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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Endoscopic Radial Artery Harvest
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring CABG, Endoscopic, Radial Artery, Radial Artery Conduit, Coronary Artery Bypass Surgery, Endoscopic technique

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • London Health Sciences Centre, University Hospital

Outcomes

Primary Outcome Measures

The primary outcome event will be the rate of forearm wound infection at 6 weeks.

Secondary Outcome Measures

Wound pain
Neurological complications
Patient satisfaction
Length of hospitalization
Histological integrity of the harvested radial artery

Full Information

First Posted
March 15, 2006
Last Updated
February 13, 2020
Sponsor
Lawson Health Research Institute
Collaborators
Johnson & Johnson
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1. Study Identification

Unique Protocol Identification Number
NCT00303706
Brief Title
Study of Endoscopic Versus Open Harvest of the Radial Artery in Coronary Artery Bypass Surgery
Official Title
A Prospective Randomized Trial of Endoscopic Versus Conventional Harvesting of the Radial Artery in Coronary Artery Bypass
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
April 2005 (Actual)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Lawson Health Research Institute
Collaborators
Johnson & Johnson

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
CABG, Endoscopic, Radial Artery, Radial Artery Conduit, Coronary Artery Bypass Surgery, Endoscopic technique

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
119 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Endoscopic Radial Artery Harvest
Primary Outcome Measure Information:
Title
The primary outcome event will be the rate of forearm wound infection at 6 weeks.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Wound pain
Time Frame
6 weeks
Title
Neurological complications
Time Frame
6 weeks
Title
Patient satisfaction
Time Frame
6 weeks
Title
Length of hospitalization
Time Frame
will vary with patient lenght of stay
Title
Histological integrity of the harvested radial artery
Time Frame
during OR

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bob Kiaii, MD, FRCSC
Organizational Affiliation
Department of Cardiac Surgery, University of Western Ontario and the London Health Sciences Centre, University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Centre, University Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
11828277
Citation
Kiaii B, Moon BC, Massel D, Langlois Y, Austin TW, Willoughby A, Guiraudon C, Howard CR, Guo LR. A prospective randomized trial of endoscopic versus conventional harvesting of the saphenous vein in coronary artery bypass surgery. J Thorac Cardiovasc Surg. 2002 Feb;123(2):204-12. doi: 10.1067/mtc.2002.118682. Erratum In: J Thorac Cardiovasc Surg 2002 Jun;123(6):1224.
Results Reference
background
PubMed Identifier
12939220
Citation
Possati G, Gaudino M, Prati F, Alessandrini F, Trani C, Glieca F, Mazzari MA, Luciani N, Schiavoni G. Long-term results of the radial artery used for myocardial revascularization. Circulation. 2003 Sep 16;108(11):1350-4. doi: 10.1161/01.CIR.0000087402.13786.D0. Epub 2003 Aug 25.
Results Reference
background
PubMed Identifier
10671327
Citation
Trick WE, Scheckler WE, Tokars JI, Jones KC, Smith EM, Reppen ML, Jarvis WR. Risk factors for radial artery harvest site infection following coronary artery bypass graft surgery. Clin Infect Dis. 2000 Feb;30(2):270-5. doi: 10.1086/313657.
Results Reference
background
PubMed Identifier
8837574
Citation
Brodman RF, Frame R, Camacho M, Hu E, Chen A, Hollinger I. Routine use of unilateral and bilateral radial arteries for coronary artery bypass graft surgery. J Am Coll Cardiol. 1996 Oct;28(4):959-63. doi: 10.1016/s0735-1097(96)00265-3.
Results Reference
background
PubMed Identifier
11326239
Citation
Denton TA, Trento L, Cohen M, Kass RM, Blanche C, Raissi S, Cheng W, Fontana GP, Trento A. Radial artery harvesting for coronary bypass operations: neurologic complications and their potential mechanisms. J Thorac Cardiovasc Surg. 2001 May;121(5):951-6. doi: 10.1067/mtc.2001.112833.
Results Reference
background
PubMed Identifier
9594852
Citation
Dumanian GA, Segalman K, Mispireta LA, Walsh JA, Hendrickson MF, Wilgis EF. Radial artery use in bypass grafting does not change digital blood flow or hand function. Ann Thorac Surg. 1998 May;65(5):1284-7. doi: 10.1016/s0003-4975(98)00176-3.
Results Reference
background
PubMed Identifier
10614806
Citation
Serricchio M, Gaudino M, Tondi P, Gasbarrini A, Gerardino L, Santoliquido A, Pola P, Possati G. Hemodynamic and functional consequences of radial artery removal for coronary artery bypass grafting. Am J Cardiol. 1999 Dec 1;84(11):1353-6, A8. doi: 10.1016/s0002-9149(99)00573-1.
Results Reference
background
PubMed Identifier
12173836
Citation
Connolly MW, Torrillo LD, Stauder MJ, Patel NU, McCabe JC, Loulmet DF, Subramanian VA. Endoscopic radial artery harvesting: results of first 300 patients. Ann Thorac Surg. 2002 Aug;74(2):502-5; discussion 506. doi: 10.1016/s0003-4975(02)03717-7.
Results Reference
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Study of Endoscopic Versus Open Harvest of the Radial Artery in Coronary Artery Bypass Surgery

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