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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00187356




Registration number
NCT00187356
Ethics application status
Date submitted
10/09/2005
Date registered
10/09/2005
Date last updated
4/06/2013

Titles & IDs
Public title
Multicentre Radial Artery Patency Study: Results of Patency Beyond 5 Years After Coronary Artery Bypass Surgery
Scientific title
Multicentre Radial Artery Patency Study: Results of Patency Beyond 5 Years After Coronary Artery Bypass Surgery
Secondary ID [1] 0 0
CIHR MCT# 52681
Universal Trial Number (UTN)
Trial acronym
RAPS - 5 years
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
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.

Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

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).
Timepoint [1] 0 0
Beyond 5 years after bypass urgery
Secondary outcome [1] 0 0
a) the proportion of occluded study grafts (TIMI 0)
Timepoint [1] 0 0
Beyond 5 years after bypass urgery
Secondary outcome [2] 0 0
b) the proportion of functionally occluded grafts where proximal stenosis of native vessel is <90% vs >90%
Timepoint [2] 0 0
Beyond 5 years after bypass urgery
Secondary outcome [3] 0 0
c) the proportion of completely occluded grafts where proximal stenosis of native vessel is <90% vs >90%
Timepoint [3] 0 0
Beyond 5 years after bypass urgery
Secondary outcome [4] 0 0
d) proportion of study grafts with string sign
Timepoint [4] 0 0
Beyond 5 years after bypass urgery

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%.
Minimum age
30 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
Manitoba
Country [3] 0 0
Canada
State/province [3] 0 0
Ontario
Country [4] 0 0
Canada
State/province [4] 0 0
Quebec
Country [5] 0 0
New Zealand
State/province [5] 0 0
Hamilton

Funding & Sponsors
Primary sponsor type
Other
Name
Sunnybrook Health Sciences Centre
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Canadian Institutes of Health Research (CIHR)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00187356
Trial related presentations / publications
Fremes SE. Multicenter radial artery patency study (RAPS). Study design. Control Clin Trials. 2000 Aug;21(4):397-413.
Public notes

Contacts
Principal investigator
Name 0 0
Stephen E Fremes, MD
Address 0 0
Sunnybrook Health Sciences Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Other publications