Percutaneous Transluminal Angioplasty Registry

February 6, 2020 updated by: Klinik für Kardiologie, Pneumologie und Angiologie

PTA Registry - an Observational Study of Percutaneous Transluminal Angioplasty

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Düsseldorf, Germany, 40225
        • Recruiting
        • Division of Cardiology, Pulmonary Disease and Vascular Medicine
        • Contact:
          • Christian Heiss, MD
        • Sub-Investigator:
          • Yvonne Heinen, MD
        • Sub-Investigator:
          • Nana-Yaw Bimpong-Buta, MD
        • Sub-Investigator:
          • Lucas Busch, MD
        • Principal Investigator:
          • Christian Heiss, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing PTA

Description

Inclusion Criteria:

  • Patients undergoing PTA

Exclusion Criteria:

  • < 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patency rate
Time Frame: 6 months
6 months
Creatinine level
Time Frame: 2 Days after PTA
2 Days after PTA

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 30 days
30 days
Days of Hospitalization
Time Frame: 12 months
Days of Hospitalization at 12 months
12 months
Ankle-Brachial Index
Time Frame: 6 months and 12 months
Clinical Improvement measured by Ankle-Brachial Index
6 months and 12 months
walking distance
Time Frame: 6 months and 12 months
Clinical Improvement measured by walking distance
6 months and 12 months
Restenosis rate
Time Frame: 12 months
Percentage of patients with restenosis at 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Klinik für Kardiologie, Pneumologie und Angiologie

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

January 1, 2030

Study Completion (Anticipated)

January 1, 2030

Study Registration Dates

First Submitted

February 18, 2016

First Submitted That Met QC Criteria

March 30, 2016

First Posted (Estimate)

April 5, 2016

Study Record Updates

Last Update Posted (Actual)

February 7, 2020

Last Update Submitted That Met QC Criteria

February 6, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • PTA Registry

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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