Clinical trial NCT01913600: Resolute Integrity US Extended Length Sub-Study(RI US XL)
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: 2013-08-01
Enrollment: 56
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: 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.

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 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.

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) ≤ 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

Primary outcomes:
measure: Composite Rate of Cardiac Death and Target Vessel Myocardial Infarction (MI)
timeFrame: 12 months
Secondary outcomes:
measure: Composite Endpoint: Major Adverse Cardiac Events (MACE)
timeFrame: 30 days, 6 months, 12 months
measure: Composite Endpoint: Target Lesion Failure (TLF)
timeFrame: 30 days, 6 months, 12 months
measure: Composite Endpoint: Target Vessel Failure (TVF),
timeFrame: 30 days, 6 months, 12 months
measure: Composite Endpoint: Cardiac Death and Target Vessel MI
timeFrame: 30 days, 6 months, 12 months
measure: Composite Endpoint: Target Vessel MI
timeFrame: 30 days, 6 months, 12 months
measure: Clinical Endpoint: Death
timeFrame: 30 days, 6 months, 12 months
measure: Clinical Endpoint: Myocardial Infarction (MI)
timeFrame: 30 days, 6 months, 12 months
measure: Clinical Endpoint: Target Lesion Revascularization (TLR)
timeFrame: 30 days, 6 months, 12 months
measure: Clinical Endpoint: Target Vessel Revascularization (TVR)
timeFrame: 30 days, 6 months, 12 months
measure: Clinical Endpoint: Stent Thrombosis
timeFrame: Early Thrombosis (<=30 days), Late Thrombosis (31-360 days)
measure: Clinical Endpoint: Stroke
timeFrame: 30 days, 6 months, 12 months
measure: Clinical Endpoint: Bleeding Complications in General
timeFrame: 30 days, 6 months, 12 months
measure: Dual Antiplatelet Therapy (DAPT) Compliance
timeFrame: 30 days, 6 months, 12 months
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: St. Joseph's Hospital Health Center
state: New York
Study officials:
References: