Resolute Integrity US Extended Length Sub-Study(RI US XL)

Not Applicable

Completed

Conditions: Coronary Artery Disease

Interventions: Device: Resolute Integrity Stent

Registration Number: NCT01913600

Lead Sponsor: Medtronic Vascular

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 56

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Resolute Integrity	Resolute Integrity Stent	Resolute Integrity Stent

Primary Outcome Measures

Name	Time	Method
Composite Rate of Cardiac Death and Target Vessel Myocardial Infarction (MI)	12 months	The combined clinical outcome of (all cause) mortality, MI or any revascularization

Secondary Outcome Measures

Name	Time	Method
Composite Endpoint: Major Adverse Cardiac Events (MACE)	30 days, 6 months, 12 months	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.
Clinical Endpoint: Target Vessel Revascularization (TVR)	30 days, 6 months, 12 months	Repeat PCI or CABG of the target vessel.
Clinical Endpoint: Stent Thrombosis	Early Thrombosis (<=30 days), Late Thrombosis (31-360 days)	All stent thrombosis data will be reported per Medtronic historical protocol definitions and according the Academic Research Consortium (ARC) definitions
Composite Endpoint: Cardiac Death and Target Vessel MI	30 days, 6 months, 12 months	Combined rate of cardiac death and target vessel MI post-procedure
Clinical Endpoint: Target Lesion Revascularization (TLR)	30 days, 6 months, 12 months	Repeat Percutaneous coronary intervention (PCI) or Coronary artery bypass grafting (CABG) to the target lesion.
Clinical Endpoint: Stroke	30 days, 6 months, 12 months	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.
Clinical Endpoint: Bleeding Complications in General	30 days, 6 months, 12 months	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.
Composite Endpoint: Target Lesion Failure (TLF)	30 days, 6 months, 12 months	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
Composite Endpoint: Target Vessel Failure (TVF),	30 days, 6 months, 12 months	The composite endpoint comprised of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization by percutaneous or surgical methods.
Clinical Endpoint: Myocardial Infarction (MI)	30 days, 6 months, 12 months	All myocardial infarction data will be reported per Medtronic historical protocol definitions and according the Academic Research Consortium (ARC) definitions.
Composite Endpoint: Target Vessel MI	30 days, 6 months, 12 months	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.
Clinical Endpoint: Death	30 days, 6 months, 12 months	All deaths including cardiac death, vasular death and non-cardiovascular death
Dual Antiplatelet Therapy (DAPT) Compliance	30 days, 6 months, 12 months	Protocol defined DAPT, Aspirin and Clopidogrel or Ticlopidine, at 30 days, 180 day and 360 days.