Clinical trial NCT01638507: An Evaluation of the Commercially Available Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: TARGET LESION REVASCULARIZATION (TLR)
TARGET VESSEL REVASCULARIZATION (TVR)
Coronary Artery Disease
MYOCARDIAL INFARCTION (MI)
PERCUTANEOUS CORONARY INTERVENTION (PCI)
STENT THROMBOSIS
TARGET LESION FAILURE (TLF)
Lead sponsor: Medtronic Vascular
Sponsor class: INDUSTRY
First posted: 2012-07-11
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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; 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

Primary outcomes:
measure: Composite Rate of Cardiac Death and Target Vessel Myocardial Infarction (MI)
timeFrame: 12 months
Secondary outcomes:
measure: Composite Endpoints: Major Adverse Cardiac Events (MACE), Target Lesion Failure (TLF), Target Vessel Failure (TVF), Cardiac Death and Target Vessel MI
timeFrame: 12 months
measure: Clinical Endpoint: Death
timeFrame: 12 months
measure: Dual Antiplatelet Therapy (DAPT) Compliance
timeFrame: 12 months
measure: Clinical Endpoint: TLR
timeFrame: 12 months
measure: Clinical Endpoint: TVR
timeFrame: 12 months
measure: Clinical Endpoint: MI
timeFrame: 12 months
measure: Clinical Endpoint: ST
timeFrame: 12 months
measure: Clinical Endpoint: Stroke
timeFrame: 12 months
measure: Clinical Endpoint: Bleeding Complications in General
timeFrame: 12 months
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: St. Joseph's Hospital Health Center
state: New York
Study officials:
affiliation: Unity Health Toronto
name: Ronald Caputo, MD
role: PRINCIPAL_INVESTIGATOR
References: