Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00187356
Registration number
NCT00187356
Ethics application status
Date submitted
10/09/2005
Date registered
16/09/2005
Date last updated
5/06/2013
Titles & IDs
Public title
Multicentre Radial Artery Patency Study: Results of Patency Beyond 5 Years After Coronary Artery Bypass Surgery
Query!
Scientific title
Multicentre Radial Artery Patency Study: Results of Patency Beyond 5 Years After Coronary Artery Bypass Surgery
Query!
Secondary ID [1]
0
0
CIHR MCT# 52681
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
RAPS - 5 years
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease
0
0
Query!
Condition category
Condition code
Cardiovascular
0
0
0
0
Query!
Coronary heart disease
Query!
Cardiovascular
0
0
0
0
Query!
Other cardiovascular diseases
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Surgery - Radial Artery and Saphenous Vein Grafts Randomized to either right coronary or left circumflex coronary artery territories
Experimental: Surgical Conduit - The 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).
Treatment: Surgery: Radial Artery and Saphenous Vein Grafts Randomized to either right coronary or left circumflex coronary artery territories
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.
Query!
Intervention code [1]
0
0
Treatment: Surgery
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
The primary endpoint will be the proportion of grafts which are functionally occluded (TIMI flow 0, 1, or 2).
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
Beyond 5 years after bypass urgery
Query!
Secondary outcome [1]
0
0
a) the proportion of occluded study grafts (TIMI 0)
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
Beyond 5 years after bypass urgery
Query!
Secondary outcome [2]
0
0
b) the proportion of functionally occluded grafts where proximal stenosis of native vessel is <90% vs >90%
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
Beyond 5 years after bypass urgery
Query!
Secondary outcome [3]
0
0
c) the proportion of completely occluded grafts where proximal stenosis of native vessel is <90% vs >90%
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
Beyond 5 years after bypass urgery
Query!
Secondary outcome [4]
0
0
d) proportion of study grafts with string sign
Query!
Assessment method [4]
0
0
Query!
Timepoint [4]
0
0
Beyond 5 years after bypass urgery
Query!
Eligibility
Key inclusion criteria
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%.
Query!
Minimum age
30
Years
Query!
Query!
Maximum age
80
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/07/2002
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/10/2010
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
269
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment outside Australia
Country [1]
0
0
Canada
Query!
State/province [1]
0
0
Alberta
Query!
Country [2]
0
0
Canada
Query!
State/province [2]
0
0
Manitoba
Query!
Country [3]
0
0
Canada
Query!
State/province [3]
0
0
Ontario
Query!
Country [4]
0
0
Canada
Query!
State/province [4]
0
0
Quebec
Query!
Country [5]
0
0
New Zealand
Query!
State/province [5]
0
0
Hamilton
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
Sunnybrook Health Sciences Centre
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
Canadian Institutes of Health Research (CIHR)
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief 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. 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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT00187356
Query!
Trial related presentations / 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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Stephen E Fremes, MD
Query!
Address
0
0
Sunnybrook Health Sciences Centre
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00187356
Download to PDF