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

Coronary Artery Disease Clinical Trial

— ENDEAVOR IV  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00217269
• Other study ID #: IP060
• Status: Completed
• Phase: N/A
• First received: September 14, 2005
• Last updated: April 19, 2012
• Start date: April 2005
• Est. completion date: July 2011

Study information

• Verified date: April 2012
• Source: Medtronic Vascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1548
• Est. completion date: July 2011
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Coronary Artery Stenting
Endeavor Drug eluting stent
• Coronary Artery Stenting
Taxus Drug Eluting Stent

Locations

Country	Name	City	State
United States	New York-Presbyterian Hospital/Columbia University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Vascular

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target vessel failure (TVF) rate		9 months	Yes
Secondary	Angiographic parameters (in-stent and in-segment) including: percent diameter stenosis (%DS)		8 months	No
Secondary	Late lumen loss (in-segment late lumen loss is a powered secondary endpoint)		9 months	No
Secondary	Late loss index		9 months	No
Secondary	Angiographic binary restenosis (ABR) rate		9 months	No
Secondary	Minimum luminal diameter (MLD)		9 months	No
Secondary	Major adverse cardiac event (MACE) rate		30 days, 6, 9, and 12 months	Yes
Secondary	Neointimal hyperplastic volume and percent volume obstruction (%VO) as measured by intravascular ultrasound (IVUS)		8 months	No
Secondary	Target site revascularization (TSR) rate and clinically-driven TSR rate		9 months	Yes
Secondary	Target vessel revascularization (TVR) rate and clinically-driven TVR rate		9 months	Yes