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The ENDEAVOR Pharmacokinetic (PK) Registry: The Medtronic Endeavor Drug Eluting Coronary Stent System (ENDEAVOR PK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00314275
Recruitment Status : Completed
First Posted : April 13, 2006
Last Update Posted : April 20, 2012
Information provided by (Responsible Party):
Medtronic Vascular

Brief Summary:
The purpose of this study is to evaluate the pharmacokinetics (PK) and safety associated with ABT-578 administered using the Medtronic Endeavor Drug Eluting Coronary Stent system in the treatment of single de novo lesions in native coronary arteries between 2.5 - 3.5 mm in diameter.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: Coronary Artery Stenting Device: Endeavor Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Pharmacokinetics (PK) and Safety of the Medtronic Endeavor Drug (ABT-578) Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions
Study Start Date : January 2006
Actual Primary Completion Date : May 2006
Actual Study Completion Date : August 2011

Arm Intervention/treatment
Experimental: ENDEAVOR
Drug Eluting Stent
Device: Coronary Artery Stenting
Drug eluting stent

Device: Endeavor
Drug eluting stent

Primary Outcome Measures :
  1. Pharmacokinetic parameters (Cmax, Tmax, AUC, T1/2, CL, etc.) [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. Success (device, lesion, and procedure) [ Time Frame: 9 months ]
  2. Major adverse cardiac event (MACE) rate [ Time Frame: 30 days, 6, 9 and 12 months ]
  3. Target site revascularization (TSR), target vessel revascularization (TVR), and target vessel failure (TVF) rate [ Time Frame: 9 months ]
  4. For patients receiving overlapping stents at the target lesion: angiographic parameters (in-stent and in-segment), including: late lumen loss [ Time Frame: 8 months ]
  5. Late loss index [ Time Frame: 9 months ]
  6. Angiographic binary restenosis (ABR) rate [ Time Frame: 9 months ]
  7. Minimum luminal diameter (MLD) [ Time Frame: 9 months ]
  8. Percent diameter stenosis (%DS) [ Time Frame: 9 months ]
  9. Neointimal hyperplastic volume as measured by intravascular ultrasound (IVUS) [ Time Frame: 8 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • The patient is at least 18 years of age.
  • The patient has 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 7 days before the procedure.
  • The patient or patient's legal representative 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.

Exclusion Criteria:

  • A known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, ticlopidine or clopidogrel, cobalt, nickel, chromium, molybdenum, polymer coatings, 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, tacrolimus, everolimus, or any other analog or derivative.
  • A platelet count < 100,000 cells/mm³ or > 700,000 cells/mm³, or a white blood cell (WBC) count < 3,000 cells/mm³.
  • A creatinine level > 2.0 mg/dL within seven days prior to index procedure. 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 2 X 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).
  • Previous percutaneous coronary intervention (PCI) of the target vessel within 9 months pre-procedure.
  • Planned PCI of any vessel within 30 days post-procedure.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00314275

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United States, California
Santa Rosa Memorial Hospital
Santa Rosa, California, United States, 95405
Sponsors and Collaborators
Medtronic Vascular
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Principal Investigator: Martin B Leon, M.D. Columbia University

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Medtronic Vascular Identifier: NCT00314275    
Other Study ID Numbers: IP-061
First Posted: April 13, 2006    Key Record Dates
Last Update Posted: April 20, 2012
Last Verified: April 2012
Keywords provided by Medtronic Vascular:
Coronary Artery Disease
Drug Eluting Stent
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases