Percutaneous Transluminal Angioplasty Registry

Percutaneous Transluminal Angioplasty Clinical Trial

Official title:

PTA Registry - an Observational Study of Percutaneous Transluminal Angioplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02728479
• Other study ID #: PTA Registry
• Status: Recruiting
• Start date: January 2014
• Est. completion date: January 2030

Study information

• Verified date: February 2020
• Source: Heinrich-Heine University, Duesseldorf
• Contact: Christian Heiss, MD
• Phone: +49 211 8118800
• Email: christian.heiss[@]med.uni-duesseldorf.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: January 2030
• Est. primary completion date: January 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing PTA

Exclusion Criteria:

• < 18 years

Related Conditions & MeSH terms

• Percutaneous Transluminal Angioplasty

Locations

Country	Name	City	State
Germany	Division of Cardiology, Pulmonary Disease and Vascular Medicine	Düsseldorf

Sponsors (1)

Lead Sponsor	Collaborator
Klinik für Kardiologie, Pneumologie und Angiologie

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patency rate		6 months
Primary	Creatinine level		2 Days after PTA
Secondary	Mortality		30 days
Secondary	Days of Hospitalization	Days of Hospitalization at 12 months	12 months
Secondary	Ankle-Brachial Index	Clinical Improvement measured by Ankle-Brachial Index	6 months and 12 months
Secondary	walking distance	Clinical Improvement measured by walking distance	6 months and 12 months
Secondary	Restenosis rate	Percentage of patients with restenosis at 12 months	12 months