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
Trial registered on ANZCTR


Registration number
ACTRN12608000072314
Ethics application status
Approved
Date submitted
7/02/2008
Date registered
8/02/2008
Date last updated
27/02/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Bare Metal BifuRcAtion SteNt Clinical Trial in Humans (IP088) With Coronary Stenosis At or Near a Vessel Bifurcation - Safety at 30-Days
Scientific title
Bare Metal Bifurcation Stent Clinical Trial in Humans (IP088) - Safety at 30 Days
Universal Trial Number (UTN)
Trial acronym
BRANCH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stenosis of Coronary Arteries 2795 0
Condition category
Condition code
Cardiovascular 2930 2930 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Angiographic placement of a bare metal coronary stent in a lesion at or near a vessel bifurcation. Stent intended for permanent placement (endothelialization into vessel wall)
Intervention code [1] 2535 0
Treatment: Devices
Comparator / control treatment
No Comparator
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3812 0
A composite of cardiac death, target vessel myocardial infarction (MI), and clinically driven target vessel revascularization (TVR)
Timepoint [1] 3812 0
30 Days post-procedure
Secondary outcome [1] 6429 0
A composite of cardiac death, target vessel MI and clinically driven TVR
Timepoint [1] 6429 0
6, 9, and 12 months post-procedure

Eligibility
Key inclusion criteria
Patient is =/> 18 years old
Acceptable candidate for Percutaneous Coronary Intervention (PCI) and Coronary Artery Bypass Graft (CABG)
Clinical evidence of ischemic heart disease
Female patients with negative pregnancy test
Informed Consent Obtained
Agrees to comply with follow-up evaluations
Single de novo bifurcation lesion in a native coronary artery with specific dimensions
Stenosis =/> 50% and < 100%
Thrombolysis in Myocardial Infarction (TIMI) flow =/> 2
Minimum age
18 Years
Maximum age
N/A
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Hypersensitivity or contraindication to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, cobalt, nickel, chromium, molybdenum
Platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3
WBC < 3,000 cells/mm3
Serum creatinine level > 170 micromol/L
Evidence of MI within 72 hours of intended trial procedure
Previous stenting in Target Vessel
LVEF < 30%
History of stroke or TIA within 6 months
History of bleeding diathesis or coagulopathy or refusal of blood transfusion
Specific target lesion morphology

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
13/02/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 764 0
3168
Recruitment outside Australia
Country [1] 780 0
New Zealand
State/province [1] 780 0

Funding & Sponsors
Funding source category [1] 3056 0
Commercial sector/Industry
Name [1] 3056 0
Medtronic Vascular
Country [1] 3056 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Medtronic Vascular
Address
3576 Unocal Place
Santa Rosa, CA 95403
Country
United States of America
Secondary sponsor category [1] 2754 0
None
Name [1] 2754 0
Address [1] 2754 0
Country [1] 2754 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5008 0
St. Vincent Hospital (Melbourne)
HREC-D
Ethics committee address [1] 5008 0
PO Box 2900
Fitzroy Victoria 3065 Australia
Ethics committee country [1] 5008 0
Australia
Date submitted for ethics approval [1] 5008 0
05/12/2007
Approval date [1] 5008 0
19/02/2008
Ethics approval number [1] 5008 0

Summary
Brief summary
A prospective multi-center, non-randomized, single arm trial enrolling up to 60 patients with symptomatic ischemic heart disease attributable to a bifurcation lesion that is amenable to percutaneous treatment with stenting.
A bifurcation lesion must have =/> 50% stenosis in the main branch.
Trial patients may have multiple vessel disease but only a single bifurcation lesion per patient mmay be treated during the trial procedure, with no other lesions of any type treated at this time-point.
Clinical follow-up assessment will be performed at 30-days post procedure.
Patient contact for follow-up assesment will be performed at 6 months, 9 months and 12 months post-procedure
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28353 0
Address 28353 0
Country 28353 0
Phone 28353 0
Fax 28353 0
Email 28353 0
Contact person for public queries
Name 11510 0
Dr Ross Prpic
Address 11510 0
Pacific Clinical Research Group (PCRG)
PO Box 139
Mosman NSW 2088
Country 11510 0
Australia
Phone 11510 0
+61 (0)438 072 765
Fax 11510 0
+61 (0)2 9383 8043
Email 11510 0
[email protected]
Contact person for scientific queries
Name 2438 0
Dr Ross Prpic
Address 2438 0
Pacific Clinical Research Group (PCRG)
PO Box 139
Mosman NSW 2088
Country 2438 0
Australia
Phone 2438 0
+61 (0)438 072 765
Fax 2438 0
+61 (0)2 9383 8043
Email 2438 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.