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

Coronary Artery Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01913600
• Other study ID #: IP 126 1D
• Status: Completed
• Phase: N/A
• Start date: July 2013
• Est. completion date: December 2018

Study information

• Verified date: April 2019
• Source: Medtronic Vascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 2018
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Resolute Integrity Stent
Drug eluting stent (DES)

Locations

Country	Name	City	State
United States	St. Joseph's Hospital Health Center	Syracuse	New York

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Vascular

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite Rate of Cardiac Death and Target Vessel Myocardial Infarction (MI)	The combined clinical outcome of (all cause) mortality, MI or any revascularization	12 months
Secondary	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.	30 days, 6 months, 12 months
Secondary	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	30 days, 6 months, 12 months
Secondary	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.	30 days, 6 months, 12 months
Secondary	Composite Endpoint: Cardiac Death and Target Vessel MI	Combined rate of cardiac death and target vessel MI post-procedure	30 days, 6 months, 12 months
Secondary	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.	30 days, 6 months, 12 months
Secondary	Clinical Endpoint: Death	All deaths including cardiac death, vasular death and non-cardiovascular death	30 days, 6 months, 12 months
Secondary	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.	30 days, 6 months, 12 months
Secondary	Clinical Endpoint: Target Lesion Revascularization (TLR)	Repeat Percutaneous coronary intervention (PCI) or Coronary artery bypass grafting (CABG) to the target lesion.	30 days, 6 months, 12 months
Secondary	Clinical Endpoint: Target Vessel Revascularization (TVR)	Repeat PCI or CABG of the target vessel.	30 days, 6 months, 12 months
Secondary	Clinical Endpoint: Stent Thrombosis	All stent thrombosis data will be reported per Medtronic historical protocol definitions and according the Academic Research Consortium (ARC) definitions	Early Thrombosis (<=30 days), Late Thrombosis (31-360 days)
Secondary	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.	30 days, 6 months, 12 months
Secondary	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.	30 days, 6 months, 12 months
Secondary	Dual Antiplatelet Therapy (DAPT) Compliance	Protocol defined DAPT, Aspirin and Clopidogrel or Ticlopidine, at 30 days, 180 day and 360 days.	30 days, 6 months, 12 months