An Evaluation of the Commercially Available Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System

Coronary Artery Disease Clinical Trial

— RI-US  

Official title:

Resolute Integrity US A Postapproval Study of the Medtronic Resolute™ Integrity 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 4.2 mm

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01638507
• Other study ID #: IP 126
• Status: Completed
• Phase: N/A
• Start date: July 2012
• Est. completion date: June 2015

Study information

• Verified date: March 2019
• Source: Medtronic Vascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this post approval study is to conduct a prospective, multicenter evaluation of the procedural and clinical outcomes of subjects that are treated with the commercially available Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System.

Description:

The purpose and objective is to assess the safety and efficacy of the Resolute Integrity Stent for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter(RD) of 2.25mm to 4.2mm in two groups of patients, specifically those patients receiving stents less than or equal to 30mm in length.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: June 2015
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• 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

• 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

• Target vessel(s) have reference vessel diameter 2.25 mm to 4.2 mm

General and Angiographic Exclusion Criteria highlights:

• Within 7 days of index procedure platelet count <100,000 cells/mm³ or >700,000 cells/mm³; White Blood Cell (WBC) count <3,000 cells/mm³; serum creatinine level >2.5 mg/dl

• Acute MI within 72 hrs of the intended trial procedure (QWMI or any elevation of Creatine Kinase-MB (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 Transient Ischemic Attack (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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Resolute Integrity Stent
Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System

Locations

Country	Name	City	State
United States	St. Joseph's Hospital Health Center	Syracuse	New York

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Vascular

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite Rate of Cardiac Death and Target Vessel Myocardial Infarction (MI)		12 months
Secondary	Composite Endpoints: Major Adverse Cardiac Events (MACE), Target Lesion Failure (TLF), Target Vessel Failure (TVF), Cardiac Death and Target Vessel MI		12 months
Secondary	Clinical Endpoint: Death		12 months
Secondary	Dual Antiplatelet Therapy (DAPT) Compliance		12 months
Secondary	Clinical Endpoint: TLR		12 months
Secondary	Clinical Endpoint: TVR		12 months
Secondary	Clinical Endpoint: MI		12 months
Secondary	Clinical Endpoint: ST		12 months
Secondary	Clinical Endpoint: Stroke		12 months
Secondary	Clinical Endpoint: Bleeding Complications in General		12 months