Status:
COMPLETED
Resolute Integrity US Extended Length Sub-Study(RI US XL)
Lead Sponsor:
Medtronic Vascular
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Prospective, multi-center, non-randomized, single-arm, open-label study to assess the safety and efficacy of the Resolute Integrity Stent for the treatment of de novo lesions in native coronary arteri...
Detailed Description
The purpose of this postapproval study is to conduct a prospective, multi-center evaluation of the procedural and clinical outcomes of subjects that are treated with the commercially available 34 mm a...
Eligibility Criteria
Inclusion
- 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) ≤ 35 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 Myocardial Infarction (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
Exclusion
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT01913600
Start Date
July 1 2013
End Date
December 1 2018
Last Update
May 8 2019
Active Locations (1)
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1
St. Joseph's Hospital Health Center
Syracuse, New York, United States, 13203