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

Coronary Artery Disease Clinical Trial

— ENDEAVOR PK  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00314275
• Other study ID #: IP-061
• Status: Completed
• Phase: N/A
• First received: April 11, 2006
• Last updated: April 19, 2012
• Start date: January 2006
• Est. completion date: August 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: August 2011
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Coronary Artery Stenting
Drug eluting stent
• Endeavor
Drug eluting stent

Locations

Country	Name	City	State
United States	Santa Rosa Memorial Hospital	Santa Rosa	California

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Vascular

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic parameters (Cmax, Tmax, AUC, T1/2, CL, etc.)		9 months	Yes
Secondary	Success (device, lesion, and procedure)		9 months	No
Secondary	Major adverse cardiac event (MACE) rate		30 days, 6, 9 and 12 months	Yes
Secondary	Target site revascularization (TSR), target vessel revascularization (TVR), and target vessel failure (TVF) rate		9 months	No
Secondary	For patients receiving overlapping stents at the target lesion: angiographic parameters (in-stent and in-segment), including: late lumen loss		8 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	Percent diameter stenosis (%DS)		9 months	No
Secondary	Neointimal hyperplastic volume as measured by intravascular ultrasound (IVUS)		8 months	No