Clincosm LogoSign in Get a demo

Percutaneous Transluminal Angioplasty Registry

Sponsor
Klinik für Kardiologie, Pneumologie und Angiologie (Other)
Overall Status
Recruiting
CT.gov ID
NCT02728479
Collaborator
(none)
1,000
Enrollment
1
Location
192
Duration (Months)
5.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Percutaneous transluminal angioplasty (PTA) is a minimally invasive procedure for dilating blood vessels in the treatment of peripheral artery disease.

The aim of this registry is to collect prospectively and systematically clinical research data from patients undergoing PTA. This registry is an open-end observational study to assess the characteristics and outcomes in patients with undergoing PTA.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    PTA Registry - an Observational Study of Percutaneous Transluminal Angioplasty
    Study Start Date :
    Jan 1, 2014
    Anticipated Primary Completion Date :
    Jan 1, 2030
    Anticipated Study Completion Date :
    Jan 1, 2030

    Outcome Measures

    Primary Outcome Measures

    1. Patency rate [6 months]

    2. Creatinine level [2 Days after PTA]

    Secondary Outcome Measures

    1. Mortality [30 days]

    2. Days of Hospitalization [12 months]

      Days of Hospitalization at 12 months

    3. Ankle-Brachial Index [6 months and 12 months]

      Clinical Improvement measured by Ankle-Brachial Index

    4. walking distance [6 months and 12 months]

      Clinical Improvement measured by walking distance

    5. Restenosis rate [12 months]

      Percentage of patients with restenosis at 12 months

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients undergoing PTA
    Exclusion Criteria:
    • < 18 years

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Division of Cardiology, Pulmonary Disease and Vascular Medicine Düsseldorf Germany 40225

    Sponsors and Collaborators

    • Klinik für Kardiologie, Pneumologie und Angiologie

    Investigators

    • Principal Investigator: Christian Heiss, MD, Division of Cardiology, Pulmonary Disease and Vascular Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Klinik für Kardiologie, Pneumologie und Angiologie, Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
    ClinicalTrials.gov Identifier:
    NCT02728479
    Other Study ID Numbers:
    • PTA Registry
    First Posted:
    Apr 5, 2016
    Last Update Posted:
    Feb 7, 2020
    Last Verified:
    Feb 1, 2020

    Study Results

    No Results Posted as of Feb 7, 2020