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Safety And Efficacy Results of Percutaneous Renal Stent Implantation in Ectatic and Aneurysmatic Coronary Arteries

Primary Purpose

Coronary Artery Ectasia

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Renal stent
Sponsored by
Bursa Postgraduate Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Ectasia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Acute coronary syndrome patients

    • 18 year age
  • ectatic/aneurysmatic coronary arteries

Exclusion Criteria:

  • Patients who underwent elective procedures,
  • experienced unsuccessful attempts
  • referred to surgical revascularization

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    renal stent group

    BMCS group

    Arm Description

    Acute coronary patients treatment with renal stent

    Acute coronary patients treatment with bare-metal stent

    Outcomes

    Primary Outcome Measures

    primary endpoints
    Rate of myocardial infarction and cardiovascular mortality

    Secondary Outcome Measures

    secondary endpoints
    Rate of restenosis and all-cause mortality

    Full Information

    First Posted
    June 4, 2022
    Last Updated
    June 7, 2022
    Sponsor
    Bursa Postgraduate Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05410678
    Brief Title
    Safety And Efficacy Results of Percutaneous Renal Stent Implantation in Ectatic and Aneurysmatic Coronary Arteries
    Official Title
    Safety And Efficacy Results of Percutaneous Renal Stent Implantation in Patients With Acute Coronary Syndrome With Ectatic and Aneurysmatic Coronary Arteries
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1, 2015 (Actual)
    Primary Completion Date
    January 1, 2022 (Actual)
    Study Completion Date
    April 1, 2022 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Bursa Postgraduate Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of this study was to evaluate the efficacy and safety of renal stents implanted in ectatic/aneurysmatic coronary arteries.
    Detailed Description
    In total, 18 patients (renal stent group) who underwent renal stent implantation in ectatic/aneurysmatic coronary arteries requiring percutaneous coronary intervention (PCI) and 45 patients who underwent large-sized bare metal coronary stent (BMCS) implantation (BMCS group) at our centre between 2015 and 2020 were included in the study. Control coronary angiography (CAG) was performed during the follow-up of these patients, and angiography-guided quantitative measurements were performed during PCI. The primary endpoints were myocardial infarction and cardiovascular mortality, and the secondary endpoints were restenosis and all-cause mortality.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronary Artery Ectasia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    63 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    renal stent group
    Arm Type
    Experimental
    Arm Description
    Acute coronary patients treatment with renal stent
    Arm Title
    BMCS group
    Arm Type
    Active Comparator
    Arm Description
    Acute coronary patients treatment with bare-metal stent
    Intervention Type
    Drug
    Intervention Name(s)
    Renal stent
    Other Intervention Name(s)
    Renal stent for coronary artery
    Intervention Description
    renal stent implantation in ectatic/aneurysmatic coronary arteries
    Primary Outcome Measure Information:
    Title
    primary endpoints
    Description
    Rate of myocardial infarction and cardiovascular mortality
    Time Frame
    2 year
    Secondary Outcome Measure Information:
    Title
    secondary endpoints
    Description
    Rate of restenosis and all-cause mortality
    Time Frame
    2 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Acute coronary syndrome patients 18 year age ectatic/aneurysmatic coronary arteries Exclusion Criteria: Patients who underwent elective procedures, experienced unsuccessful attempts referred to surgical revascularization

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Safety And Efficacy Results of Percutaneous Renal Stent Implantation in Ectatic and Aneurysmatic Coronary Arteries

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