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Completed

NCT Number: NCT01913600

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Joseph's Hospital Health Center

Syracuse, New York, 13203, United States

About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resolute Integrity Stent

Device

Drug eluting stent (DES)

Primary outcomes

  1. Composite Rate of Cardiac Death and Target Vessel Myocardial Infarction (MI)

    Time frame: 12 months

    The combined clinical outcome of (all cause) mortality, MI or any revascularization

Secondary outcomes

  1. Composite Endpoint: Major Adverse Cardiac Events (MACE)

    Time frame: 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.

  2. Composite Endpoint: Target Lesion Failure (TLF)

    Time frame: 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

  3. Composite Endpoint: Target Vessel Failure (TVF),

    Time frame: 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.

  4. Composite Endpoint: Cardiac Death and Target Vessel MI

    Time frame: 30 days, 6 months, 12 months

    Combined rate of cardiac death and target vessel MI post-procedure

  5. Composite Endpoint: Target Vessel MI

    Time frame: 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.

  6. Clinical Endpoint: Death

    Time frame: 30 days, 6 months, 12 months

    All deaths including cardiac death, vasular death and non-cardiovascular death

  7. Clinical Endpoint: Myocardial Infarction (MI)

    Time frame: 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.

  8. Clinical Endpoint: Target Lesion Revascularization (TLR)

    Time frame: 30 days, 6 months, 12 months

    Repeat Percutaneous coronary intervention (PCI) or Coronary artery bypass grafting (CABG) to the target lesion.

  9. Clinical Endpoint: Target Vessel Revascularization (TVR)

    Time frame: 30 days, 6 months, 12 months

    Repeat PCI or CABG of the target vessel.

  10. Clinical Endpoint: Stent Thrombosis

    Time frame: 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

  11. Clinical Endpoint: Stroke

    Time frame: 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.

  12. Clinical Endpoint: Bleeding Complications in General

    Time frame: 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.

  13. Dual Antiplatelet Therapy (DAPT) Compliance

    Time frame: 30 days, 6 months, 12 months

    Protocol defined DAPT, Aspirin and Clopidogrel or Ticlopidine, at 30 days, 180 day and 360 days.

Sponsors and collaborators

Lead sponsor

Medtronic Vascular

Industry

Registry information

Official study 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

Acronym: RI-US XL

Important dates

Study start
2013
Primary completion
2016
Study completion
2018
First posted
Aug 1, 2013
Registry last updated
May 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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