This trial is active, not recruiting.

Condition coronary artery disease
Treatment resolute zotarolimus-eluting coronary stent
Sponsor Medtronic Vascular
Start date July 2008
End date January 2011
Trial size 1516 participants
Trial identifier NCT00726453, IP102


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Implantation of a Resolute Zotarolimus-Eluting Coronary Stent
resolute zotarolimus-eluting coronary stent
Implantation of a Resolute Zotarolimus-Eluting Coronary Stent

Primary Outcomes

Target Lesion Failure (TLF)
time frame: 12 Months

Secondary Outcomes

Target Vessel Failure (TVF)
time frame: 12 months
Major Adverse Cardiac Event (MACE)
time frame: 12 months
time frame: 12 months
Target Vessel MI
time frame: 12 months
Stent Thrombosis (ST)
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Clinical Evaluation of the Medtronic Resolute Zotarolimus-Eluting Coronary Stent System in the Treatment of De Novo Lesions in Native Coronary Arteries With a Reference Vessel Diameter of 2.25 mm to 4.2mm
Principal investigator Martin B Leon, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Medtronic Vascular.