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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
56
Drug eluting stent (DES)
St. Joseph's Hospital Health Center
Syracuse, New York, United States
Composite Rate of Cardiac Death and Target Vessel Myocardial Infarction (MI)
The combined clinical outcome of (all cause) mortality, MI or any revascularization
Time frame: 12 months
Composite Endpoint: Major Adverse Cardiac Events (MACE)
Defined as death, myocardial infarction (Q wave and non-Q wave), emergent coronary bypass surgery, or clinically-driven repeat target lesion revascularization by percutaneous or surgical methods.
Time frame: 30 days, 6 months, 12 months
Composite Endpoint: Target Lesion Failure (TLF)
Defined as cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or clinically-driven target lesion revascularization (TLR) by percutaneous or surgical methods
Time frame: 30 days, 6 months, 12 months
Composite Endpoint: Target Vessel Failure (TVF),
The composite endpoint comprised of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization by percutaneous or surgical methods.
Time frame: 30 days, 6 months, 12 months
Composite Endpoint: Cardiac Death and Target Vessel MI
Combined rate of cardiac death and target vessel MI post-procedure
Time frame: 30 days, 6 months, 12 months
Composite Endpoint: Target Vessel MI
Target-vessel MI is defined as a MI that occurs in a territory that cannot be clearly attributed to a vessel other than the target vessel.
Time frame: 30 days, 6 months, 12 months
Clinical Endpoint: Death
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All deaths including cardiac death, vasular death and non-cardiovascular death
Time frame: 30 days, 6 months, 12 months
Clinical Endpoint: Myocardial Infarction (MI)
All myocardial infarction data will be reported per Medtronic historical protocol definitions and according the Academic Research Consortium (ARC) definitions.
Time frame: 30 days, 6 months, 12 months
Clinical Endpoint: Target Lesion Revascularization (TLR)
Repeat Percutaneous coronary intervention (PCI) or Coronary artery bypass grafting (CABG) to the target lesion.
Time frame: 30 days, 6 months, 12 months
Clinical Endpoint: Target Vessel Revascularization (TVR)
Repeat PCI or CABG of the target vessel.
Time frame: 30 days, 6 months, 12 months
Clinical Endpoint: Stent Thrombosis
All stent thrombosis data will be reported per Medtronic historical protocol definitions and according the Academic Research Consortium (ARC) definitions
Time frame: Early Thrombosis (<=30 days), Late Thrombosis (31-360 days)
Clinical Endpoint: Stroke
Defined as sudden onset of vertigo, numbness, dysphasia, weakness, visual field defects, dysarthria or other focal neurological deficits due to vascular lesions of the brain such as hemorrhage, embolism, thrombosis, or rupturing aneurysm, that persists more than 24 hours.
Time frame: 30 days, 6 months, 12 months
Clinical Endpoint: Bleeding Complications in General
Bleeding complications in general including the GUSTO classification of Severe, Moderate \& Mild will be collected. The GUSTO scale defines clinical events that stratify bleeding episodes into mild, moderate or severe.
Time frame: 30 days, 6 months, 12 months
Dual Antiplatelet Therapy (DAPT) Compliance
Protocol defined DAPT, Aspirin and Clopidogrel or Ticlopidine, at 30 days, 180 day and 360 days.
Time frame: 30 days, 6 months, 12 months