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Coronary Artery DiseasePhase 3RAPS - 5 yearsNCT00187356

Multicentre Radial Artery Patency Study: Results of Patency Beyond 5 Years After Coronary Artery Bypass Surgery

A Phase 3 study testing Radial Artery and Saphenous Vein Grafts Randomized to either right coronary or left circumflex coronary artery territories in people with Coronary Artery Disease, run by Sunnybrook Health Sciences Centre at 13 sites in 2 countries.

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

Bypass surgery is often required to treat severe coronary heart disease. Either arteries or veins can be used as bypass grafts. We wish to compare the long-term durability of the saphenous vein from the leg to that of the radial artery from the fore-arm when used as bypass grafts. Read more about this study

Who is it for?
Ages 30 to 80 years
Conditions the study is for
Coronary Artery Disease
What is being tested?
Radial Artery and Saphenous Vein Grafts Randomized to either right coronary or left circumflex coronary artery territories
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
269 participants
Where
13 sitesin 2 countries
Study dates
Jul 2002to Oct 2010
Phase
Phase 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 30 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient population consists of patients who were enroled into the original Multicentre Radial Artery Patency Study between November 1996 and January 2001. These included patients undergoing isolated coronary artery bypass surgery less than 80 years of age with 3 vessel coronary disease and left ventricular ejection fraction greater than 35%.

Who cannot join

  • Exclusion criteria included 1: Inability to use the radial artery or saphenous vein conduits: a)nonpalpable ulnar arteries or a positive Allen's test, b) an abnormal Doppler study or ultrasonographic study of the arms, c) a history of vasculitis or Raynaud's syndrome, bilateral varicose veins or vein stripping. 2: Conditions that affected the safety of follow-up angiography: a)renal insufficiency (creatinine > 180 umol/L) b)severe peripheral vascular disease precluding femoral access b)coagulopathy or obligatory uninterrupted use of anticoagulants c) known allergy to radiographic contrast media d) women of childbearing potential e) comorbid illness which precludes the use of follow up angiography f) geographically inaccessible for follow up angiography.

Trial locations and contacts

13 sites in 2 countries.

13 sites in 2 countries

Canada12 sites

  • University of Alberta

    Edmonton, Alberta, T6G 2B7

  • Laval Hospital

    Laval, Quebec, G1V4G5

  • London Health Sciences Centre - UC

    London, Ontario, N6A 5A5

  • London Health Sciences Centre - VC

    London, Ontario, N6B1B1

  • Montreal Heart Institute

    Montreal, Quebec, H1T 1C8

  • Montreal Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • Ottawa Heart Institute

    Ottawa, Ontario, K1Y 4W7

  • Sunnybrook and Women's College HSC

    Toronto, Ontario, M4N3M5

  • St. Michael's Hospital

    Toronto, Ontario, M5B1W8

  • Toronto General Hospital

    Toronto, Ontario, M5G2C4

  • Vancouver General Hospital

    Vancouver, Ontario, V5Z1C6

  • Manitoba Health Sciences Centre

    Winnipeg, Manitoba, R3A 1R9

Other trials in Canada

New Zealand1 site

  • Waikato Hospital

    Hamilton

Other trials in New Zealand

About this study

Bypass surgery is often required to treat severe coronary heart disease. Either arteries or veins can be used as bypass grafts. We wish to compare the long-term durability of the saphenous vein from the leg to that of the radial artery from the fore-arm when used as bypass grafts. We are examining how many of these grafts are still functioning beyond 5 years after bypass surgery by performing a coronary angiogram. After 1-year, we found that radial arteries were more likely to be functioning than saphenous veins. We hypothesize that radial arteries will continue to be superior beyond 5 years.

Read the detailed description

The multi-centre Radial Artery Patency Study, (RAPS) is a series of longitudinal graft patency studies designed to compare the long-term patency of the radial artery to the saphenous vein. Between 1996 and 2001, 561 patients were intraoperatively randomized to undergo surgery according to one of two strategies: radial-artery grafting to the circumflex territory and saphenous-vein grafting to the right coronary artery or radial-artery grafting to the right coronary artery and saphenous-vein grafting to the circumflex territory. The first study compared the 8-12 month angiographic patency of the radial artery with that of the saphenous vein as a conduit for coronary artery bypass and found that radial arteries were superior. The primary objective of this current study is to determine the beyond 5-year angiographic patency of the radial artery compared with a saphenous vein coronary bypass graft.

HYPOTHESES

  1. The angiographic patency of radial artery grafts studied beyond 5 years following surgery exceeds that of saphenous vein grafts.
  2. Radial artery conduits studied beyond 5 years postoperatively have less graft disease than saphenous veins.

SAMPLE SIZE We expect to study 350 patients, which will allow us to test for a 35% risk reduction from 23% occlusion rate in saphenous veins to 15% in radial arteries, assuming a 5% within-patient correlation, with 80% power for a 2-tailed alpha of 0.05.

Being tested
Radial Artery and Saphenous Vein Grafts Randomized to either right coronary or left circumflex coronary artery territories
Keywords
Coronary Bypass Surgery, Coronary Artery Disease, Angiography, Arterial Grafts, Radial Artery, Saphenous Vein
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.

  • Radial Artery and Saphenous Vein Grafts Randomized to either right coronary or left circumflex coronary artery territoriesProcedure or surgery

    Each patient will receive both study grafts (Radial artery and Study Saphenous vein graft). The within-patient randomization scheme will dictate whether the radial goes to the right or circumflex territory. The saphenous vein graft will go to the opposing territory.

Study groups in NCT00187356
Study groupRoleWhat they receive
Surgical ConduitExperimentalThe surgical arm will be composed of the experimental arm (the use of the radial artery) versus an active comparator (the use of the saphenous vein graft).
Receives: Procedure: Radial Artery and Saphenous Vein Grafts Randomized to either right coronary or left circumflex coronary artery territories

What is being measured

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

  1. The primary endpoint will be the proportion of grafts which are functionally occluded (TIMI flow 0, 1, or 2).

    Measured: Beyond 5 years after bypass urgery

Secondary outcomes (4)

  1. a) the proportion of occluded study grafts (TIMI 0)

    Measured: Beyond 5 years after bypass urgery

  2. b) the proportion of functionally occluded grafts where proximal stenosis of native vessel is <90% vs >90%

    Measured: Beyond 5 years after bypass urgery

  3. c) the proportion of completely occluded grafts where proximal stenosis of native vessel is <90% vs >90%

    Measured: Beyond 5 years after bypass urgery

  4. d) proportion of study grafts with string sign

    Measured: Beyond 5 years after bypass urgery

Timeline

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

  1. First posted16 Sep 2005 (estimated)
  2. Study startJul 2002
  3. Primary completionSep 2010
  4. Study completionOct 2010

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
269 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00187356
Sponsor's protocol ID
CIHR MCT# 52681
Acronym
RAPS - 5 years
Status last verified
Jun 2013
First submitted
10 Sep 2005
Last updated
5 Jun 2013
Results posted
No

Publications

  • Fremes SE. Multicenter radial artery patency study (RAPS). Study design. Control Clin Trials. 2000 Aug;21(4):397-413. doi: 10.1016/s0197-2456(00)00059-3.

    PubMed 10913815

  • Desai ND, Cohen EA, Naylor CD, Fremes SE; Radial Artery Patency Study Investigators. A randomized comparison of radial-artery and saphenous-vein coronary bypass grafts. N Engl J Med. 2004 Nov 25;351(22):2302-9. doi: 10.1056/NEJMoa040982.

    PubMed 15564545

  • Deb S, Cohen EA, Singh SK, Une D, Laupacis A, Fremes SE; RAPS Investigators. Radial artery and saphenous vein patency more than 5 years after coronary artery bypass surgery: results from RAPS (Radial Artery Patency Study). J Am Coll Cardiol. 2012 Jul 3;60(1):28-35. doi: 10.1016/j.jacc.2012.03.037.

    PubMed 22742399

  • Tam DY, Deb S, Nguyen B, Ko DT, Karkhanis R, Moussa F, Fremes J, Cohen EA, Radhakrishnan S, Fremes SE. The radial artery is protective in women and men following coronary artery bypass grafting-a substudy of the radial artery patency study. Ann Cardiothorac Surg. 2018 Jul;7(4):492-499. doi: 10.21037/acs.2018.05.19.

    PubMed 30094213

  • Deb S, Singh SK, Moussa F, Tsubota H, Une D, Kiss A, Tomlinson G, Afshar M, Sless R, Cohen EA, Radhakrishnan S, Dubbin J, Schwartz L, Fremes SE; Radial Artery Patency Study Investigators. The long-term impact of diabetes on graft patency after coronary artery bypass grafting surgery: a substudy of the multicenter Radial Artery Patency Study. J Thorac Cardiovasc Surg. 2014 Oct;148(4):1246-53; discussion 1253. doi: 10.1016/j.jtcvs.2014.06.057. Epub 2014 Jul 17.

    PubMed 25109754

  • Yanagawa B, Algarni KD, Singh SK, Deb S, Vincent J, Elituv R, Desai ND, Rajamani K, McManus BM, Liu PP, Cohen EA, Radhakrishnan S, Dubbin JD, Schwartz L, Fremes SE. Clinical, biochemical, and genetic predictors of coronary artery bypass graft failure. J Thorac Cardiovasc Surg. 2014 Aug;148(2):515-520.e2. doi: 10.1016/j.jtcvs.2013.10.011. Epub 2013 Dec 9.

    PubMed 24332189

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Radial Artery and Saphenous Vein Grafts Randomized to either right coronary or left circumflex coronary artery territories in people with Coronary Artery Disease, run by Sunnybrook Health Sciences Centre at 13 sites in 2 countries.

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 5 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Canada, New Zealand. 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 phase mean?

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 endpoint will be the proportion of grafts which are functionally occluded (TIMI flow 0, 1, or 2). (time frame: Beyond 5 years after bypass urgery). 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 NCT00187356, which also lists 6 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 5 Jun 2013.

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