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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01638507
First Posted: July 11, 2012
Last Update Posted: May 22, 2017
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.
Information provided by (Responsible Party):
Medtronic Vascular
July 9, 2012
July 11, 2012
October 23, 2015
November 25, 2015
May 22, 2017
July 2012
June 2014   (Final data collection date for primary outcome measure)
Composite Rate of Cardiac Death and Target Vessel Myocardial Infarction (MI) [ Time Frame: 12 months ]
Same as current
Complete list of historical versions of study NCT01638507 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Clinical Endpoint: Death [ Time Frame: 12 months ]
  • Dual Antiplatelet Therapy (DAPT) Compliance [ Time Frame: 12 months ]
  • Clinical Endpoint: TLR [ Time Frame: 12 months ]
  • Clinical Endpoint: TVR [ Time Frame: 12 months ]
  • Clinical Endpoint: MI [ Time Frame: 12 months ]
  • Clinical Endpoint: ST [ Time Frame: 12 months ]
  • Clinical Endpoint: Stroke [ Time Frame: 12 months ]
  • Clinical Endpoint: Bleeding Complications in General [ Time Frame: 12 months ]
  • Composite Endpoints: Major Adverse Cardiac Events (MACE), Target Lesion Failure (TLF), Target Vessel Failure (TVF), Cardiac Death and Target Vessel MI [ Time Frame: 30 days, 6 months, 12 months and 24 months post-procedure: ]
  • Clinical endpoints: Death, Myocardial Infarction, Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), Stent Thrombosis, Stroke, Bleeding complications in general [ Time Frame: 30 days, 6 months, 12 months and 24 months post-procedure: ]
  • Dual Antiplatelet Therapy (DAPT) Compliance [ Time Frame: 30 days, 6 months, 12 months and 24 months post-procedure ]
Not Provided
Not Provided
 
An Evaluation of the Commercially Available Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System
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.
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.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Coronary Artery Disease
Device: Resolute Integrity Stent
Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System
Resolute Integrity
Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System (Resolute Integrity Stent)
Intervention: Device: Resolute Integrity Stent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
230
June 2015
June 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01638507
IP 126
No
Not Provided
Not Provided
Medtronic Vascular
Medtronic Vascular
Not Provided
Principal Investigator: Ronald Caputo, MD St. Joseph Hospital Health Center
Medtronic Vascular
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP