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Coronary Artery DiseaseRI-US XLNCT01913600

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

A study testing Resolute Integrity Stent in people with Coronary Artery Disease, run by Medtronic Vascular at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
Resolute Integrity Stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteUnited States
Study dates
Jul 2013to Dec 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • St. Joseph's Hospital Health Center

    Syracuse, New York, 13203

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Resolute Integrity Stent
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)
Medical subject headings
Coronary Artery Disease, Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Resolute Integrity StentDevice

    Drug eluting stent (DES)

Study groups in NCT01913600
Study groupRoleWhat they receive
Resolute IntegrityOtherResolute Integrity Stent
Receives: Device: Resolute Integrity Stent

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 12 months

Secondary outcomes (13)

  1. 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.

    Measured: 30 days, 6 months, 12 months

  2. 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

    Measured: 30 days, 6 months, 12 months

  3. 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.

    Measured: 30 days, 6 months, 12 months

  4. Composite Endpoint: Cardiac Death and Target Vessel MI

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

    Measured: 30 days, 6 months, 12 months

  5. 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.

    Measured: 30 days, 6 months, 12 months

  6. Clinical Endpoint: Death

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

    Measured: 30 days, 6 months, 12 months

  7. 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.

    Measured: 30 days, 6 months, 12 months

  8. Clinical Endpoint: Target Lesion Revascularization (TLR)

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

    Measured: 30 days, 6 months, 12 months

  9. Clinical Endpoint: Target Vessel Revascularization (TVR)

    Repeat PCI or CABG of the target vessel.

    Measured: 30 days, 6 months, 12 months

  10. Clinical Endpoint: Stent Thrombosis

    All stent thrombosis data will be reported per Medtronic historical protocol definitions and according the Academic Research Consortium (ARC) definitions

    Measured: Early Thrombosis (<=30 days), Late Thrombosis (31-360 days)

  11. 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.

    Measured: 30 days, 6 months, 12 months

  12. 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.

    Measured: 30 days, 6 months, 12 months

  13. Dual Antiplatelet Therapy (DAPT) Compliance

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

    Measured: 30 days, 6 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2013 (estimated)
  2. Study startJul 2013
  3. Primary completionOct 2016
  4. Study completionDec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01913600
Sponsor's protocol ID
IP 126 1D
Acronym
RI-US XL
Status last verified
Apr 2019
First submitted
30 Jul 2013
Last updated
8 May 2019
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Resolute Integrity Stent in people with Coronary Artery Disease, run by Medtronic Vascular at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite Rate of Cardiac Death and Target Vessel Myocardial Infarction (MI) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01913600.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2019.

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