An Evaluation of the Commercially Available Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System (RI-US)

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Resolute Integrity Stent

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 230
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Syracuse, New York, United States, 13203
      • St. Joseph's Hospital Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Resolute Integrity; Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System (Resolute Integrity Stent)	Device: Resolute Integrity Stent; Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Composite Rate of Cardiac Death and Target Vessel Myocardial Infarction (MI)	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Composite Endpoints: Major Adverse Cardiac Events (MACE), Target Lesion Failure (TLF), Target Vessel Failure (TVF), Cardiac Death and Target Vessel MI	12 months
Clinical Endpoint: Death	12 months
Dual Antiplatelet Therapy (DAPT) Compliance	12 months
Clinical Endpoint: TLR	12 months
Clinical Endpoint: TVR	12 months
Clinical Endpoint: MI	12 months
Clinical Endpoint: ST	12 months
Clinical Endpoint: Stroke	12 months
Clinical Endpoint: Bleeding Complications in General	12 months

Collaborators and Investigators

• Sponsor: Medtronic Vascular
• Investigators: Principal Investigator: Ronald Caputo, MD, Unity Health Toronto

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: July 9, 2012
• First Submitted That Met QC Criteria: July 10, 2012
• First Posted (Estimate): July 11, 2012

Study Record Updates

• Last Update Posted (Actual): April 3, 2019
• Last Update Submitted That Met QC Criteria: March 22, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; PERCUTANEOUS CORONARY INTERVENTION (PCI); MYOCARDIAL INFARCTION (MI); TARGET VESSEL REVASCULARIZATION (TVR); TARGET LESION REVASCULARIZATION (TLR); STENT THROMBOSIS; TARGET LESION FAILURE (TLF)
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: IP 126