Bare Metal Bifurcation Stent Clinical Trial in Humans

Study Overview
=================
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.

Official Title
-----------------
The Medtronic Bare Metal Bifurcation Stent Clinical Trial in Humans

Conditions
-----------------
Coronary Artery Disease, Myocardial Ischemia

Intervention / Treatment
-----------------
* Device: Medtronic Bifurcation Stent System


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Medtronic Bifurcation Stent System | Device: Medtronic Bifurcation Stent System<br>* Percutaneous Coronary Stenting<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | During index procedure | 
| 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. | 6 month | 
| 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. | 9 month | 
| 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. | 12 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
restenosis, Coronary Disease, Coronary Arteriosclerosis, Arterial Occlusive Diseases