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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01638507
Recruitment Status : Completed
First Posted : July 11, 2012
Results First Posted : November 25, 2015
Last Update Posted : May 22, 2017
Information provided by (Responsible Party):
Medtronic Vascular

Brief 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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: Resolute Integrity Stent Not Applicable

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  (Clinical Trial)
Actual Enrollment : 230 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : July 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Composite Rate of Cardiac Death and Target Vessel Myocardial Infarction (MI) [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Composite Endpoints: Major Adverse Cardiac Events (MACE), Target Lesion Failure (TLF), Target Vessel Failure (TVF), Cardiac Death and Target Vessel MI [ Time Frame: 12 months ]
  2. Clinical Endpoint: Death [ Time Frame: 12 months ]
  3. Dual Antiplatelet Therapy (DAPT) Compliance [ Time Frame: 12 months ]
  4. Clinical Endpoint: TLR [ Time Frame: 12 months ]
  5. Clinical Endpoint: TVR [ Time Frame: 12 months ]
  6. Clinical Endpoint: MI [ Time Frame: 12 months ]
  7. Clinical Endpoint: ST [ Time Frame: 12 months ]
  8. Clinical Endpoint: Stroke [ Time Frame: 12 months ]
  9. Clinical Endpoint: Bleeding Complications in General [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01638507

United States, New York
St. Joseph's Hospital Health Center
Syracuse, New York, United States, 13203
Sponsors and Collaborators
Medtronic Vascular
Principal Investigator: Ronald Caputo, MD St. Joseph Hospital Health Center

Responsible Party: Medtronic Vascular Identifier: NCT01638507     History of Changes
Other Study ID Numbers: IP 126
First Posted: July 11, 2012    Key Record Dates
Results First Posted: November 25, 2015
Last Update Posted: May 22, 2017
Last Verified: April 2017

Keywords provided by Medtronic Vascular:
Coronary Artery Disease

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs