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

NCT01913600 | Completed Results

• 1 other identifier: IP 126 1D
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

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)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Composite Endpoint: Major Adverse Cardiac Events (MACE)

  30 days, 6 months, 12 months

• Composite Endpoint: Target Lesion Failure (TLF)

  30 days, 6 months, 12 months

• Composite Endpoint: Target Vessel Failure (TVF),

  30 days, 6 months, 12 months

• Composite Endpoint: Cardiac Death and Target Vessel MI

  30 days, 6 months, 12 months

• Composite Endpoint: Target Vessel MI

  30 days, 6 months, 12 months

Study Arms (1)

Resolute Integrity

OTHER

Resolute Integrity Stent

Device: Resolute Integrity Stent

Interventions

Resolute Integrity Stent DEVICE

Drug eluting stent (DES)

Resolute Integrity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Vascular: lead

Study Sites (1)

St. Joseph's Hospital Health Center

Syracuse, New York, 13203, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Infarction

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Results Point of Contact

• Title: Lisa Bousquette, Clinical Research Director
• Organization: Medtronic, Coronary & Structural Heart Clinical

rs.medtroniccardiovascularclinicaltrials@medtronic.com

707-591-2967

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2013
• First Posted: August 1, 2013
• Study Start: July 1, 2013
• Primary Completion: October 1, 2016
• Study Completion: December 1, 2018
• Last Updated: May 8, 2019
• Results First Posted: November 17, 2017

Record last verified: 2019-04

Locations

US (1)