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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT01638507
First received: July 9, 2012
Last updated: July 31, 2013
Last verified: July 2013
  Purpose

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 Intervention
Coronary Artery Disease
Procedure: Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System (Resolute Integrity Stent)

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Medtronic Vascular:

Primary Outcome Measures:
  • Composite rate of cardiac death and target vessel myocardial infarction (MI) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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: ] [ Designated as safety issue: Yes ]
  • 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: ] [ Designated as safety issue: Yes ]
  • Dual antiplatelet therapy (DAPT) compliance [ Time Frame: 30 days, 6 months, 12 months and 24 months post-procedure ] [ Designated as safety issue: No ]

Enrollment: 230
Study Start Date: July 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Resolute Integrity
Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System (Resolute Integrity Stent)
Procedure: Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System (Resolute Integrity Stent)
Other Name: 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 tow groups of patients, specifically those patients receiving stents less than or equal to 30mm in length.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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; 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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01638507

Locations
United States, New York
St. Joseph's Hospital Health Center
Syracuse, New York, United States, 13203
Sponsors and Collaborators
Medtronic Vascular
  More Information

No publications provided

Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT01638507     History of Changes
Other Study ID Numbers: IP 126
Study First Received: July 9, 2012
Last Updated: July 31, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Medtronic Vascular:
TARGET LESION REVASCULARIZATION (TLR)
TARGET VESSEL REVASCULARIZATION (TVR)
Coronary Artery Disease
MYOCARDIAL INFARCTION (MI)
PERCUTANEOUS CORONARY INTERVENTION (PCI)
STENT THROMBOSIS
TARGET LESION FAILURE (TLF)

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014