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Procedural Advantages of a Novel Drug-Eluting Coronary Stent

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Synergy Stent
Currently common drug-eluting stent (DES)
Sponsored by
University Hospital Heidelberg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • CAD for PCI, consecutive patients

Exclusion Criteria:

  • Age under 18
  • Bare Metal Stents or Scaffolds

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Common DES

    Synergy Stent

    Arm Description

    Group of Patients with narrowed coronary artery disease, who were treated with an implantation of currently established drug-eluting stents (Xience Prime, Promus Element plus, Resolute Integrity).

    Group of Patients with narrowed coronary artery disease, who were treated with Synergy stent implantation

    Outcomes

    Primary Outcome Measures

    In-hospital major cardiac adverse events
    In-hospital major cardiac adverse events were collected up to one week after procedure throughout the in-patients stay

    Secondary Outcome Measures

    Full Information

    First Posted
    August 15, 2016
    Last Updated
    August 25, 2016
    Sponsor
    University Hospital Heidelberg
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02881216
    Brief Title
    Procedural Advantages of a Novel Drug-Eluting Coronary Stent
    Official Title
    Procedural Advantages of a Novel Drug-Eluting Coronary Stent With Ultra-Thin Struts and Bioabsorbable Abluminal Polymer Coating in an All-Comers Registry
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2015 (undefined)
    Primary Completion Date
    December 2015 (Actual)
    Study Completion Date
    June 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Hospital Heidelberg

    4. Oversight

    5. Study Description

    Brief Summary
    This study sought to compare procedural performance of a new coronary stent generation, that is already available in Germany, with hitherto established current drug-eluting stents.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    814 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Common DES
    Arm Type
    Other
    Arm Description
    Group of Patients with narrowed coronary artery disease, who were treated with an implantation of currently established drug-eluting stents (Xience Prime, Promus Element plus, Resolute Integrity).
    Arm Title
    Synergy Stent
    Arm Type
    Other
    Arm Description
    Group of Patients with narrowed coronary artery disease, who were treated with Synergy stent implantation
    Intervention Type
    Device
    Intervention Name(s)
    Synergy Stent
    Other Intervention Name(s)
    Synergy Coronary Stent
    Intervention Description
    Patients with narrowed coronary artery disease qualifying for PCI were treated with Synergy stent implantation.
    Intervention Type
    Device
    Intervention Name(s)
    Currently common drug-eluting stent (DES)
    Other Intervention Name(s)
    DES including Xience Prime, Resolute Integrity, Promus Element Plus.
    Intervention Description
    Patients with narrowed coronary artery disease qualifying for PCI were treated with DES implantation (Xience Prime, Resolute Integrity, Promus Element Plus)
    Primary Outcome Measure Information:
    Title
    In-hospital major cardiac adverse events
    Description
    In-hospital major cardiac adverse events were collected up to one week after procedure throughout the in-patients stay
    Time Frame
    One week post-procedure

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: CAD for PCI, consecutive patients Exclusion Criteria: Age under 18 Bare Metal Stents or Scaffolds

    12. IPD Sharing Statement

    Learn more about this trial

    Procedural Advantages of a Novel Drug-Eluting Coronary Stent

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