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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT00314275
First received: April 11, 2006
Last updated: April 19, 2012
Last verified: April 2012
  Purpose

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 Intervention
Coronary Artery Disease
Device: Coronary Artery Stenting
Device: Endeavor

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Medtronic Vascular:

Primary Outcome Measures:
  • Pharmacokinetic parameters (Cmax, Tmax, AUC, T1/2, CL, etc.) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Success (device, lesion, and procedure) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Major adverse cardiac event (MACE) rate [ Time Frame: 30 days, 6, 9 and 12 months ] [ Designated as safety issue: Yes ]
  • Target site revascularization (TSR), target vessel revascularization (TVR), and target vessel failure (TVF) rate [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • For patients receiving overlapping stents at the target lesion: angiographic parameters (in-stent and in-segment), including: late lumen loss [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Late loss index [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Angiographic binary restenosis (ABR) rate [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Minimum luminal diameter (MLD) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Percent diameter stenosis (%DS) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Neointimal hyperplastic volume as measured by intravascular ultrasound (IVUS) [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Enrollment: 43
Study Start Date: January 2006
Study Completion Date: August 2011
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ENDEAVOR
Drug Eluting Stent
Device: Coronary Artery Stenting
Drug eluting stent
Device: Endeavor
Drug eluting stent

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00314275

Locations
United States, California
Santa Rosa Memorial Hospital
Santa Rosa, California, United States, 95405
Sponsors and Collaborators
Medtronic Vascular
Investigators
Principal Investigator: Martin B Leon, M.D. Columbia University College of Physicians and Surgeons
  More Information

No publications provided by Medtronic Vascular

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT00314275     History of Changes
Other Study ID Numbers: IP-061
Study First Received: April 11, 2006
Last Updated: April 19, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Medtronic Vascular:
Pharmacokinetics
Coronary Artery Disease
PCI
Drug Eluting Stent

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 18, 2014