search
Back to results

Safety and Efficacy of the Percutaneous Intervention Performed With Devices of a Single-brand (Tsunami)

Primary Purpose

Atherosclerotic Heart Disease, Coronary Heart Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Coronary stent - Tsunami
Sponsored by
Hospital Sao Lucas da PUCRS
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atherosclerotic Heart Disease

Eligibility Criteria

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

Inclusion Criteria:

The study included both male and female patients for stent implantation referred for angioplasty of coronary arteries with more than 18 years.

Exclusion Criteria:

  • chronic total occlusion angioplasty,
  • saphenous graft angioplasty,
  • bifurcation angioplasty (lateral branch greater than 1.5 mm)
  • plans to perform angioplasty on more than one vessel during the same procedure
  • and primary angioplasty in acute myocardial infarction

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Occurrence of: need to change the materials during the procedure (angioplasty).

    Secondary Outcome Measures

    Full Information

    First Posted
    June 26, 2012
    Last Updated
    July 2, 2012
    Sponsor
    Hospital Sao Lucas da PUCRS
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01632501
    Brief Title
    Safety and Efficacy of the Percutaneous Intervention Performed With Devices of a Single-brand
    Acronym
    Tsunami
    Official Title
    Safety and Efficacy of the Percutaneous Intervention Performed With Devices of a Single-brand
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2011 (undefined)
    Primary Completion Date
    March 2012 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital Sao Lucas da PUCRS

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The freedom of choice in medicine is based on the physician's ability to treat their patients with the best available therapy. The armamentarium for percutaneous intervention is frequently determined on the basis of subjective criteria and the experience of the interventional cardiologist. The evaluation of devices used in coronary intervention, especially angiography and its clinical outcomes, has rarely been investigated; the exceptions are studies on stents. Therefore, the freedom of choice for the interventional cardiologist has been challenged, especially because of cost restrictions. This way this study aims to assess the safety and efficacy of a device of a single brand in performing percutaneous transluminal coronary angioplasty (guide catheters, guidewires, balloons, and stents) in selected patients.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    84 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    Coronary stent - Tsunami
    Intervention Description
    A coronary angioplasty was done
    Primary Outcome Measure Information:
    Title
    Occurrence of: need to change the materials during the procedure (angioplasty).
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The study included both male and female patients for stent implantation referred for angioplasty of coronary arteries with more than 18 years. Exclusion Criteria: chronic total occlusion angioplasty, saphenous graft angioplasty, bifurcation angioplasty (lateral branch greater than 1.5 mm) plans to perform angioplasty on more than one vessel during the same procedure and primary angioplasty in acute myocardial infarction

    12. IPD Sharing Statement

    Learn more about this trial

    Safety and Efficacy of the Percutaneous Intervention Performed With Devices of a Single-brand

    We'll reach out to this number within 24 hrs