Bare Metal Bifurcation Stent Clinical Trial in Humans (BRANCH)

Medtronic

Status

Completed

Conditions

Coronary Artery Disease

Myocardial Ischemia

Treatments

Device: Medtronic Bifurcation Stent System

Study type

Interventional

Funder types

Industry

Identifiers

NCT00607321

IP088

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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)