The ENDEAVOR IV Clinical Trial: A Trial of a Coronary Stent System in Coronary Artery Lesions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT00217269
First received: September 14, 2005
Last updated: April 19, 2012
Last verified: April 2012
  Purpose

The purpose of this study is to assess the equivalence in safety and efficacy of the Endeavor Drug Eluting Coronary Stent System when compared to the Taxus Paclitaxel-Eluting Coronary Stent System for the treatment of single de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.5-3.5 mm.


Condition Intervention
Coronary Artery Disease
Device: Coronary Artery Stenting

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled Trial of the Medtronic Endeavor Drug (ABT-578) Eluting Coronary Stent System Versus the Taxus Paclitaxel-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:
  • Target vessel failure (TVF) rate [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Angiographic parameters (in-stent and in-segment) including: percent diameter stenosis (%DS) [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Late lumen loss (in-segment late lumen loss is a powered secondary endpoint) [ Time Frame: 9 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 ]
  • Major adverse cardiac event (MACE) rate [ Time Frame: 30 days, 6, 9, and 12 months ] [ Designated as safety issue: Yes ]
  • Neointimal hyperplastic volume and percent volume obstruction (%VO) as measured by intravascular ultrasound (IVUS) [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Target site revascularization (TSR) rate and clinically-driven TSR rate [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Target vessel revascularization (TVR) rate and clinically-driven TVR rate [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Enrollment: 1548
Study Start Date: April 2005
Study Completion Date: July 2011
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Endeavor Drug Eluting Stent
Device: Coronary Artery Stenting
Endeavor Drug eluting stent
Active Comparator: 2
Taxus Drug Eluting Stent
Device: Coronary Artery Stenting
Taxus Drug Eluting Stent

Detailed Description:

The ENDEAVOR IV Trial is a prospective, multi-center, randomized, two-arm, single-blind trial that will enroll a total of 1,548 patients at up to 80 sites in the US. The ENDEAVOR IV Trial will assess if the Endeavor stent is equivalent in safety and efficacy to the Taxus stent for the treatment of single de novo lesions in native coronary arteries with a RVD of 2.5-3.5 mm.

  Eligibility

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

Inclusion Criteria:

  • 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/Ethics Committee (IRB/EC) of the respective clinical site.
  • The patient agrees to return to the same research facility for all required post-procedure follow-up visits.

Exclusion Criteria:

  • A known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, ticlopidine or clopidogrel, cobalt, nickel, chromium, molybdenum, polymer coatings (e.g., Phosphorylcholine or Translute), or a sensitivity to contrast media, which cannot be adequately pre-medicated.
  • History of an allergic reaction or significant sensitivity to drugs such as ABT-578, rapamycin, tacrolimus, everolimus, or any other analogue or derivative.
  • History of an allergic reaction or significant sensitivity to paclitaxel or drugs in similar class.
  • A platelet count < 100,000 cells/mm³ or > 700,000 cells/mm³, or a white blood cell (WBC) count < 3,000 cells/mm³.
  • A serum creatinine level > 2.0 mg/dl within seven days prior to index procedure.
  • Evidence of an acute MI within 72 hours of the intended index procedure (defined as: QWMI or non-Q wave myocardial infarction (NQWMI) having CK enzymes > 2X the upper laboratory normal with the presence of a CK-MB elevated above the Institution's upper limit of normal).
  • Previous 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 (including but not limited to, cutting balloon, any atherectomy, any laser, thrombectomy, etc.).
  • History of a stroke or transient ischemic attack (TIA) 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, IVUS or other coronary artery imaging procedures.
  • Documented left ventricular ejection fraction (LVEF) < 30% at most recent evaluation.
  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: NCT00217269

Locations
United States, New York
New York-Presbyterian Hospital/Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Medtronic Vascular
Investigators
Principal Investigator: Martin B. Leon, M.D. Columbia University College of Physicians & 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: NCT00217269     History of Changes
Other Study ID Numbers: IP060
Study First Received: September 14, 2005
Last Updated: April 19, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Medtronic Vascular:
Restenosis

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 19, 2014