The Medtronic RESOLUTE US Clinical Trial

Coronary Artery Disease Clinical Trial

— R-US  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00726453
• Other study ID #: IP102
• Status: Active, not recruiting
• Phase: N/A
• First received: July 30, 2008
• Last updated: January 20, 2016
• Start date: July 2008
• Est. completion date: June 2016

Study information

• Verified date: January 2016
• 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 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1516
• Est. completion date: June 2016
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy 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:
• Resolute Zotarolimus-Eluting Coronary Stent
Implantation of a Resolute Zotarolimus-Eluting Coronary Stent

Locations

Country	Name	City	State
United States	East Texas Medical Center	Tyler	Texas

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 Lesion Failure (TLF)	Target Lesion Failure (TLF) at 12 months post-procedure, defined as Cardiac Death, Target Vessel Myocardial Infarction (TVMI) (Q wave and non-Q wave) or clinically-driven Target Lesion Revascularization (TLR) by percutaneous or surgical methods.	12 Months	Yes
Secondary	Target Vessel Failure (TVF)	Target Vessel Failure (TVF) composite endpoint and each individual component (Cardiac Death, Target Vessel MI, or clinically-driven Target Vessel Revascularization (TVR) by percutaneous or surgical methods).	12 months	Yes
Secondary	Major Adverse Cardiac Event (MACE)	Major Adverse Cardiac Event (MACE) composite endpoint and each individual component (death, Target Vessel MI (Q wave and non-Q wave), emergent coronary bypass surgery (CABG), or clinically-driven repeat Target Lesion Revascularization (TLR) by percutaneous or surgical methods).	12 months	Yes
Secondary	Death		12 months	Yes
Secondary	Target Vessel MI	Target Vessel MI (as determined by extended historical and ARC definitions).	12 months	Yes
Secondary	Stent Thrombosis (ST)	Stent Thrombosis (ST) (as determined by historic and ARC definitions).	12 months	Yes

External Links

•   Medtronic Clinical Trials Link
•   Medtronic Home Page