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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00607321




Registration number
NCT00607321
Ethics application status
Date submitted
22/01/2008
Date registered
5/02/2008
Date last updated
18/05/2017

Titles & IDs
Public title
Bare Metal Bifurcation Stent Clinical Trial in Humans
Scientific title
The Medtronic Bare Metal Bifurcation Stent Clinical Trial in Humans
Secondary ID [1] 0 0
IP088
Universal Trial Number (UTN)
Trial acronym
BRANCH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 0 0
Myocardial Ischemia 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: Devices - Medtronic Bifurcation Stent System

Experimental: 1 - Medtronic Bifurcation Stent System


Treatment: Devices: Medtronic Bifurcation Stent System
Percutaneous Coronary Stenting
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Target Vessel Failure (TVF) at 30 Days Post Procedure.
Timepoint [1] 0 0
30 days
Secondary outcome [1] 0 0
Device Success
Timepoint [1] 0 0
During index procedure
Secondary outcome [2] 0 0
Number of Participants With Target Vessel Failure (TVF) at 6 Months
Timepoint [2] 0 0
6 month
Secondary outcome [3] 0 0
Number of Participants With Target Vessel Failure at 9 Months.
Timepoint [3] 0 0
9 month
Secondary outcome [4] 0 0
Number of Participant With Target Vessel Failure at 12 Months
Timepoint [4] 0 0
12 month

Eligibility
Key inclusion criteria
General Inclusion Criteria

* Candidate for percutaneous coronary intervention & emergent coronary artery bypass graft surgery
* Clinical evidence of ischemic heart disease or a positive functional study
* Female patients of childbearing potential has negative pregnancy test within 7 days before trial procedure
* Patient or patient's legal representative provided written informed consent
* Patient agrees to comply with follow-up evaluations

Angiographic Inclusion Criteria

* Target lesion ia a single de novo bifurcation lesion involving a native coronary artery with reference vessel diameter for the proximal main of 3.8 - 4.3 mm, distal main of 3.0 - 3.5 mm, & side branch RVD up to 2.5 mm
* Acceptable target lesion lengths are any combination of:
* <16mm proximally from carina in proximal main vessel
* <16mm distally from the carina in distal main branch
* <12mm from carina in side branch
* Target lesion in main vessel has stenosis of > 50% and <100%
* Target vessel has (TIMI) flow >2

General
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

* Known hypersensitivity/contraindication to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, cobalt, nickel, chromium, molybdenum, or sensitivity to contrast media, which can't be adequately pre-medicated
* Platelet count <100,000 cells/mm³ or >700,000 cells/mm³, or a white blood cell (WBC) count <3,000 cells/mm³ within 7 days prior to index procedure
* Serum creatinine level >170 micromol/L within 7 days prior to index procedure
* Evidence of acute MI within 72 hours of intended trial procedure (defined as: QWMI or NQWMI having CK enzymes >2X laboratory upper limit of normal with presence of elevated CK-MB (any amount above laboratory upper limit of normal)
* Previous stenting anywhere in target vessel
* PCI of non-target vessel within 30 days prior to procedure that results in any MACE event. If non target vessel stent is implanted within 72 hours prior to index procedure, 2 post procedural serial CK or CK-MB measurements must be below investigational site's upper limit of normal.
* PCI of non-target vessel within 24 hours prior to procedure
* Planned PCI of any vessel within 30 days post-procedure
* Planned PCI of the target vessel within 6 months post-procedure
* During index procedure, target lesion requires treatment with device other than PTCA or cutting balloon prior to stent placement
* Documented left ventricular ejection fraction (LVEF) <30% at most recent evaluation.
* History of stroke or transient ischemic attack (TIA) within prior 6 months
* Active peptic ulcer or upper gastrointestinal (GI) bleeding within prior 6 months
* History of bleeding diathesis or coagulopathy or will refuse blood transfusions
* Concurrent medical condition with life expectancy < 12 months
* Currently participating in investigational drug or device trial that's not completed the primary endpoint or that clinically interferes with current trial endpoints; or requires coronary angiography, IVUS or other coronary artery imaging procedures.

Angiographic Exclusion Criteria

* Bifurcation angle of >90 degrees by visual estimate
* Target lesion located in native vessel with saphenous vein graft or left/right internal mammary artery (LIMA/RIMA) bypass
* Significant stenosis (>50%) proximal or distal to target lesion that might require revascularization or impede run off.
* Target vessel is excessively tortuous (two bends >90º to reach target lesion)
* Target lesion has any of following characteristics:
* Lesion location is aorto-ostial, unprotected left main lesion, or within 5 mm of origin of left anterior descending (LAD), left circumflex (LCX), or right coronary artery (RCA).
* Severely calcified
* Evidence of thrombus
* Co-existence of unprotected left main coronary artery disease (obstruction >50% in left main coronary artery)

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
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
NA
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
1/02/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2010
Sample size
Target
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Medtronic Vascular
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ian Meredith, MD
Address 0 0
Monash Medical 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 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

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00607321