The Medtronic RESOLUTE US Clinical Trial (R-US)

Medtronic

Status

Completed

Conditions

Coronary Artery Disease

Treatments

Device: Resolute Zotarolimus-Eluting Coronary Stent

Study type

Interventional

Funder types

Industry

Identifiers

NCT00726453

IP102

Details and patient eligibility

About

The objective of the study is to assess the safety and effectiveness of the Resolute Zotarolimus-Eluting Coronary Stent System for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm.

Full description

The trial is comprised of four studies: the 2.25 mm - 3.5 mm main study (1242 patients), the 2.25 mm - 3.5 mm Angio/IVUS sub-study (100 patients), the 4.0 mm sub-study (60 patients), and the 38 mm Length Sub-study (114 patients). A patient's inclusion in a given study is dependent on the size (diameter or length) of the stent(s) the patient receives.

Enrollment

1,516 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

General and Angiographic Inclusion Criteria highlights:

Acceptable candidate for percutaneous coronary intervention (PCI),stenting, and emergency coronary artery bypass graft surgery
Clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia and/or positive functional study
Informed consent
Patient agrees to comply with specified follow-up evaluations at same investigational site
Single target lesion or two target lesions located in separate coronary arteries
De novo lesion(s) in native coronary artery(ies)
Target lesion(s) ≤ 27 mm in length (or ≤ 35 mm for a lesion to be treated with a 38 mm length stent)
Target vessel(s) have reference vessel diameter 2.25 mm to 4.2 mm, (or 3.0 to 4.2 mm for it to be treated with a 38 mm length stent)

General and Angiographic Exclusion Criteria highlights:

Within 7 days of implant platelet count <100,000 cells/mm³ or >700,000 cells/mm³; WBC count <3,000 cells/mm³; serum creatinine level >2.5 mg/dl
Acute MI within 72 hrs of the index procedure (QWMI or any elevation of CK-MB > lab upper limit of normal)
Previous PCI of target vessel(s) within 9 months prior to the procedure
Planned PCI of any vessel within 30 days post-index procedure and/or planned PCI of target vessel(s) within 12 months post-index procedure
History of stroke or TIA within prior 6 months
Participating in investigational drug/device study that has not completed primary endpoint or interferes with study endpoints
Inability to comply with required trial antiplatelet regimen
Previous stent in target vessel unless it has been at least 9 months since stent placed and target lesion(s) is/are at least 15 mm from previous stent
Target vessel(s) has/have other lesions w/ > 40% diameter stenosis
Unprotected left main coronary artery disease