The Clinical Response Evaluation of the Medtronic Endeavor CR ABT-578 Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions

Medtronic Vascular1 site in 1 country139 target enrollmentNovember 2005

ConditionsCoronary Artery Disease

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Medtronic Vascular
Enrollment: 139
Locations: 1
Primary Endpoint: Late lumen loss (in-stent) as measured by quantitative coronary angiography (QCA)
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To evaluate the clinical safety, efficacy, and pharmacokinetics (PK) of the Endeavor Resolute Zotorolimus Eluting Coronary Stent System for the treatment of single de novo lesions in native coronary arteries with a reference vessel diameter (RVD) between 2.5 and 3.5 mm in diameter.

Registry

clinicaltrials.gov

Start Date

November 2005

End Date

October 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Medtronic Vascular

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient is at least 18 years old
•Patient is an acceptable candidate for percutaneous coronary intervention and emergent coronary artery bypass graft surgery
•Patient has clinical evidence of ischemic heart disease or a positive functional study
•Female patients of childbearing potential must have a negative pregnancy test within 7 days before the trial procedure
•Patient or patient's legal representative has been informed of the nature of the trial and agrees to its provisions and has provided written informed consent as approved by Human Research Ethics Committee of the respective investigational site
•Patient agrees to comply with specified follow-up evaluations and to return to the same investigational site where the procedure was performed. Patients participating in the PK sub-study must agree to the additional follow-up procedures as required by the sub-study

Exclusion Criteria

•Known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, cobalt, nickel, chromium, molybdenum, polymer coating components 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
•Platelet count \< 100,000 cells/mm³ or \> 700,000 cells/mm³, or a white blood cell (WBC) count \< 3,000 cells/mm³
•Serum creatinine level \> 170 micromol/L within 7 days prior to index procedure
•Evidence of an acute myocardial infarction within 72 hours of the intended trial procedure (defined as: Q wave myocardial infarction or non-Q wave myocardial infarction having CK enzymes \> 2X the laboratory upper limit of normal with the presence of an elevated CK-MB (any amount above the laboratory upper limit of normal))
•Previous stenting anywhere in the target vessel
•PCI of the target vessel within 30 days prior to the procedure
•Implantation of a drug eluting stent in any non-target vessel within 30 days prior to the procedure. Implantation of a Cypher stent in any non-target vessel within 90 days prior to the procedure
•PCI of a non-target vessel with a bare metal stent within 30 days prior to the procedure that results in any MACE event. If the bare metal stent is implanted within 72 hours prior to the procedure, a post procedural serial CK or CK-MB measurement above the investigational site's upper limit of normal (two below upper normal required for enrollment)
•PCI of a non-target vessel within 24 hours prior to the procedure

Outcomes

Primary Outcomes

Late lumen loss (in-stent) as measured by quantitative coronary angiography (QCA)

Time Frame: 9 months

Secondary Outcomes

Major adverse cardiac event (MACE) rate(30 days, 4, 6, 9 & 12 months)
Acute success (device, lesion, and procedure)(4 or 9 Months)
Target vessel failure (TVF)(9 months)
Target lesion revascularization (TLR)(9 months)
Neointimal hyperplastic volume and percent volume obstruction (%VO) as measured by intravascular ultrasound (IVUS)(4 or 9 months)
Pharmacokinetic parameters(last measurement at 60 days)
Angiographic parameters (in-stent and in-segment)(4 or 9 months)