Overview

This trial is active, not recruiting.

Condition coronary artery disease
Treatment resolute integrity stent
Sponsor Medtronic Vascular
Start date July 2013
End date December 2016
Trial size 56 participants
Trial identifier NCT01913600, IP 126 1D

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 arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm in patients who receive extended length stents (34 mm or 38 mm) referred to as the Extended Length Study.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Resolute Integrity Stent
resolute integrity stent
Drug eluting stent (DES)

Primary Outcomes

Measure
Composite rate of cardiac death and target vessel myocardial infarction (MI)
time frame: 30 days, 6 months, 12 months and 24 months, 3 years, 4 years, 5 years post-procedure

Secondary Outcomes

Measure
Composite endpoint: Major Adverse Cardiac Events (MACE)
time frame: 30 days, 6 months, 12 months and 24 months, 3 years, 4 years, 5 years post-procedure
Composite endpoint: Target Lesion Failure (TLF)
time frame: 30 days, 6 months, 12 months and 24 months, 3 years, 4 years, 5 years post-procedure
Composite endpoint: Target Vessel Failure (TVF),
time frame: 30 days, 6 months, 12 months and 24 months, 3 years, 4 years, 5 years post-procedure
Composite endpoint: Cardiac Death and Target Vessel MI
time frame: 30 days, 6 months, 12 months and 24 months, 3 years, 4 years, 5 years post-procedure
Composite endpoint: Target Vessel MI
time frame: 30 days, 6 months, 12 months and 24 months, 3 years, 4 years, 5 years post-procedure
Clinical endpoint: Death
time frame: 30 days, 6 months, 12 months and 24 months, 3 years, 4 years, 5 years post-procedure
Clinical endpoint: Myocardial Infarction (MI)
time frame: 30 days, 6 months, 12 months and 24 months, 3 years, 4 years, 5 years post-procedure
Clinical endpoint: Target Lesion Revascularization (TLR)
time frame: 30 days, 6 months, 12 months and 24 months, 3 years, 4 years, 5 years post-procedure
Clinical endpoint: Target Vessel Revascularization (TVR)
time frame: 12 months
Clinical endpoint: Stent Thrombosis
time frame: 30 days, 6 months, 12 months and 24 months, 3 years, 4 years, 5 years post-procedure
Clinical endpoint: Stroke
time frame: 30 days, 6 months, 12 months and 24 months, 3 years, 4 years, 5 years post-procedure
Clinical endpoint: Bleeding complications in general
time frame: 30 days, 6 months, 12 months and 24 months, 3 years, 4 years, 5 years post-procedure
Dual antiplatelet therapy (DAPT) compliance
time frame: 30 days, 6 months, 12 months and 24 months, 3 years, 4 years, 5 years post-procedure

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
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 and 38 mm Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System. Descriptive statistics and 95% confidence intervals will be calculated for clinically relevant variables as described in a separate statistical analysis plan.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Medtronic Vascular.