Bare Metal Bifurcation Stent Clinical Trial in Humans (BRANCH)

This study has been completed.
Sponsor:
Information provided by:
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT00607321
First received: January 22, 2008
Last updated: August 1, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Myocardial Ischemia
Device: Medtronic Bifurcation Stent System

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Medtronic Bare Metal Bifurcation Stent Clinical Trial in Humans

Resource links provided by NLM:


Further study details as provided by Medtronic Vascular:

Primary Outcome Measures:
  • Number of Participants With Target Vessel Failure (TVF) at 30 Days Post Procedure. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Device Success [ Time Frame: During index procedure ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Target Vessel Failure (TVF) at 6 Months [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
    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.

  • Number of Participants With Target Vessel Failure at 9 Months. [ Time Frame: 9 month ] [ Designated as safety issue: Yes ]
    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.

  • Number of Participant With Target Vessel Failure at 12 Months [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 60
Study Start Date: February 2008
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Medtronic Bifurcation Stent System
Device: Medtronic Bifurcation Stent System
Percutaneous Coronary Stenting

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00607321

Locations
New Zealand
Auckland City Hospital
Auckland, New Zealand
Sponsors and Collaborators
Medtronic Vascular
Investigators
Principal Investigator: Ian Meredith, MD Monash Medical Centre
  More Information

No publications provided

Responsible Party: Judith L Jaeger, Medtronic Vascular
ClinicalTrials.gov Identifier: NCT00607321     History of Changes
Other Study ID Numbers: IP088
Study First Received: January 22, 2008
Results First Received: August 1, 2011
Last Updated: August 1, 2011
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Medtronic Vascular:
restenosis
Coronary Disease
Coronary Arteriosclerosis
Arterial Occlusive Diseases

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2014