Status:
COMPLETED
The Medtronic Endeavor III Drug Eluting Coronary Stent System Clinical Trial
Lead Sponsor:
Medtronic Vascular
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To demonstrate the equivalency in in-segment late lumen loss at 8 months between the Endeavor Drug Eluting Coronary Stent System coated with ABT-578 (10 micrograms/mm) and the Cypher Sirolimus-Eluting...
Detailed Description
The ENDEAVOR III Trial is a prospective, multi-center, single-blind, randomized trial that enrolled 436 patients at 29 sites in the US. The purpose of this trial is to demonstrate the equivalency of i...
Eligibility Criteria
Inclusion
- The patient is at least 18 years of age.
- The patient must have clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia, or a positive functional study.
- The patient is an acceptable candidate for percutaneous transluminal coronary angioplasty (PTCA), stenting, and emergent coronary artery bypass graft (CABG) surgery.
- Female patients of childbearing potential must have a negative pregnancy test within seven (7) days before the procedure.
- The patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board of the respective clinical site.
- The patient and the treating physician agree that the patient will return to the treating research center, or an affiliated institution under the same IRB jurisdiction, for all required post-procedure follow-up visits. A research staff member who has been properly trained to the Endeavor III protocol must conduct all follow-up evaluations.
Exclusion
- A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, cobalt, nickel, chromium, molybdenum, or a sensitivity to contrast media, which cannot be adequately pre-medicated.
- History of an allergic reaction or significant sensitivity to drugs similar to ABT-578 (rapamycin or rapamycin analog).
- A platelet count \< 100,000 cells/mm³ or \> 700,000 cells/mm³, or a WBC \< 3,000 cells/mm³.
- A creatinine level \> 2.0 mg/dL.
- Evidence of an acute myocardial infarction within 72 hours of the intended treatment (defined as: Q wave or non-Q wave myocardial infarction having creatine kinase (CK) enzymes greater than or equal to 2X the upper laboratory normal with the presence of a creatine kinase myocardial-band isoenzyme (CK-MB) elevated above the Institution's upper limit of normal).
- Any previous or planned treatment of any vessel with a drug eluting stent.
- Previous or planned percutaneous coronary intervention of any vessel within 30 days pre or post procedure.
- Previous stenting anywhere in the target vessel.
- During the index procedure, the target lesion requires treatment with a device other than PTCA prior to stent placement (such as, but not limited to, cutting balloon, directional coronary atherectomy, excimer laser, rotational atherectomy, thrombectomy, etc.).
- History of a stroke or transient ischemic attack within the prior 6 months.
- Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months.
- History of bleeding diathesis or coagulopathy or will refuse blood transfusions.
- Concurrent medical condition with a life expectancy of less than 12 months.
- Any previous or planned treatment of the target vessel with anti-restenotic therapies including, but not limited to brachytherapy.
- Currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints; or requires coronary angiography, intravascular ultrasound (IVUS) or other coronary artery imaging procedures.
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
436 Patients enrolled
Trial Details
Trial ID
NCT00217256
Start Date
February 1 2004
End Date
December 1 2010
Last Update
June 27 2011
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