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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00607321
Ethics application status
Date submitted
22/01/2008
Date registered
4/02/2008
Date last updated
18/04/2017

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
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

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. - TVF was reported if any of the following events occurred: Recurrent MI in territory not clearly attributed to a vessel other than the target lesion; Cardiac death not clearly due to a non-target vessel endpoint or Clinically driven target revascularization.
Timepoint [1] 0 0
30 days
Secondary outcome [1] 0 0
Device Success - Device success is reported as Historical-standard definition: attainment of <50% residual stenosis of all target lesion/s using only the assigned device and any adjunct stents as specified in the Investigational Plan.
Timepoint [1] 0 0
During index procedure
Secondary outcome [2] 0 0
Number of Participants With Target Vessel Failure (TVF) at 6 Months - TVF was reported if any of the following events occurred: Recurrent MI in territory not clearly attributed to a vessel other than the target lesion; Cardiac death not clearly due to a non-target vessel endpoint or Clinically driven target revascularization.
Timepoint [2] 0 0
6 month
Secondary outcome [3] 0 0
Number of Participants With Target Vessel Failure at 9 Months. - TVF was reported if any of the following events occurred: Recurrent MI in territory not clearly attributed to a vessel other than the target lesion; Cardiac death not clearly due to a non-target vessel endpoint or Clinically driven target revascularization.
Timepoint [3] 0 0
9 month
Secondary outcome [4] 0 0
Number of Participant With Target Vessel Failure at 12 Months - TVF was reported if any of the following events occurred: Recurrent MI in territory not clearly attributed to a vessel other than the target lesion; Cardiac death not clearly due to a non-target vessel endpoint or Clinically driven target revascularization.
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
Gender
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
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
Not Applicable
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
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
To assess the feasibility and safety of the Medtronic Bifurcation Stent System for the
treatment of single de novo bifurcation lesions in native coronary arteries with reference
vessel diameters (RVD) for the proximal main vessel of 3.8 - 4.3 mm, distal main branch of
3.0 - 3.5 mm, and side branch RVD up to 2.5 mm.
Trial website
https://clinicaltrials.gov/show/NCT00607321
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 data has been provided for results reporting
Summary results
Other publications