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Coronary Artery DiseasePhase 2/3NCT00303706

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

A Phase 2/3 study testing Endoscopic Radial Artery Harvest in people with Coronary Artery Disease, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Coronary Artery Disease
What is being tested?
Endoscopic Radial Artery Harvest
Type of treatment
Surgery or procedure
How many people
119 participants
Where
1 siteCanada
Study dates
Apr 2005to Aug 2007
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • London Health Sciences Centre, University Hospital

    London, Ontario, N6A 5A5

Other trials in Canada

About this study

Official title: A Prospective Randomized Trial of Endoscopic Versus Conventional Harvesting of the Radial Artery in Coronary Artery Bypass

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.

Read the 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.

Being tested
Endoscopic Radial Artery Harvest
Keywords
CABG, Endoscopic, Radial Artery, Radial Artery Conduit, Coronary Artery Bypass Surgery, Endoscopic technique
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endoscopic Radial Artery HarvestProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 6 weeks

Secondary outcomes (5)

  1. Wound pain

    Measured: 6 weeks

  2. Neurological complications

    Measured: 6 weeks

  3. Patient satisfaction

    Measured: 6 weeks

  4. Length of hospitalization

    Measured: will vary with patient lenght of stay

  5. Histological integrity of the harvested radial artery

    Measured: during OR

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2006 (estimated)
  2. Study startApr 2005
  3. Study completionAug 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
119 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00303706
Sponsor's protocol ID
R-05-053
Status last verified
Feb 2020
First submitted
15 Mar 2006
Last updated
17 Feb 2020
Results posted
No

Publications

  • 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.

    PubMed 11828277

  • 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.

    PubMed 12939220

  • 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.

    PubMed 10671327

  • 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.

    PubMed 8837574

  • 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.

    PubMed 11326239

  • 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.

    PubMed 9594852

  • 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.

    PubMed 10614806

  • 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.

    PubMed 12173836

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Endoscopic Radial Artery Harvest in people with Coronary Artery Disease, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary outcome event will be the rate of forearm wound infection at 6 weeks. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00303706, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.

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