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

NCT00303706 | Completed Phase 2

• 1 other identifier: R-05-053
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

CABG, Endoscopic, Radial Artery; Radial Artery Conduit; Coronary Artery Bypass Surgery; Endoscopic technique

Outcome Measures

Primary Outcomes (1)

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

  6 weeks

Secondary Outcomes (5)

• Wound pain

  6 weeks

• Neurological complications

  6 weeks

• Patient satisfaction

  6 weeks

• Length of hospitalization

  will vary with patient lenght of stay

• Histological integrity of the harvested radial artery

  during OR

Interventions

Endoscopic Radial Artery Harvest PROCEDURE

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patient's refusal to have surgery, inability to give informed consent, and contraindication in harvesting the radial artery.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Johnson & Johnson: collaborator

Study Sites (1)

London Health Sciences Centre, University Hospital

London, Ontario, N6A 5A5, Canada

Location

Related Publications (8)

• 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.

  PMID: 11828277 BACKGROUND

• 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.

  PMID: 12939220 BACKGROUND

• 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.

  PMID: 10671327 BACKGROUND

• 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.

  PMID: 8837574 BACKGROUND

• 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.

  PMID: 11326239 BACKGROUND

• 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.

  PMID: 9594852 BACKGROUND

• 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.

  PMID: 10614806 BACKGROUND

• 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.

  PMID: 12173836 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Bob Kiaii, MD, FRCSC

  Department of Cardiac Surgery, University of Western Ontario and the London Health Sciences Centre, University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 15, 2006
• First Posted: March 17, 2006
• Study Start: April 1, 2005
• Study Completion: August 1, 2007
• Last Updated: February 17, 2020

Record last verified: 2020-02

Locations

CA (1)