Bare Metal Bifurcation Stent Clinical Trial in Humans (BRANCH)

• ClinicalTrials.gov Identifier: NCT00607321
• Recruitment Status: Completed
• First Posted: February 5, 2008
• Results First Posted: August 31, 2011
• Last Update Posted: May 18, 2017
• Sponsor: Medtronic Vascular
• Information provided by (Responsible Party): Medtronic Vascular

Tracking Information

• First Submitted Date: January 22, 2008
• First Posted Date: February 5, 2008
• Results First Submitted Date: August 1, 2011
• Results First Posted Date: August 31, 2011
• Last Update Posted Date: May 18, 2017
• Study Start Date: February 2008
• Actual Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 1, 2011)

Number of Participants With Target Vessel Failure (TVF) at 30 Days Post Procedure. [ Time Frame: 30 days ]

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.

• Original Primary Outcome Measures (submitted: February 4, 2008): A composite of cardiac death, target vessel myocardial infarction (MI) and clinically driven target vessel revascularization (TVR) at 30 days post procedure. [ Time Frame: 30 days ]

Current Secondary Outcome Measures (submitted: August 1, 2011)

• Device Success [ Time Frame: During index procedure ]
  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 ]
  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 ]
  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 ]
  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.

Original Secondary Outcome Measures (submitted: February 4, 2008)

• Acute device success [ Time Frame: During index procedure ]
• Total fluoroscopy time [ Time Frame: During index procedure ]
• Total volume of contrast used [ Time Frame: During index procedure ]
• Total index PCI procedure time [ Time Frame: During index procedure ]
• Target vessel failure (TVF) [ Time Frame: 6 mo, 9 mo, 12 mo ]
• Target lesion revascularization (TLR) rate [ Time Frame: 9 mo ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Bare Metal Bifurcation Stent Clinical Trial in Humans
• Official Title: The Medtronic Bare Metal Bifurcation Stent Clinical Trial in Humans
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Coronary Artery Disease
• Myocardial Ischemia

Intervention

Device: Medtronic Bifurcation Stent System

Percutaneous Coronary Stenting

Study Arms

Experimental: 1

Medtronic Bifurcation Stent System

Intervention: Device: Medtronic Bifurcation Stent System

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 4, 2008): 60
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: August 2010
• Actual Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)

Eligibility 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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: New Zealand

Administrative Information

• NCT Number: NCT00607321
• Other Study ID Numbers: IP088
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Medtronic Vascular
• Study Sponsor: Medtronic Vascular
• Collaborators: Not Provided

Investigators

• Principal Investigator: Ian Meredith, MD; Monash Medical Centre

• PRS Account: Medtronic Vascular
• Verification Date: April 2017