NCT02728479

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
45mo left

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Jan 2014Jan 2030

Study Start

First participant enrolled

January 1, 2014

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 5, 2016

Completed
13.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

February 7, 2020

Status Verified

February 1, 2020

Enrollment Period

16 years

First QC Date

February 18, 2016

Last Update Submit

February 6, 2020

Conditions

Percutaneous Transluminal Angioplasty

Outcome Measures

Primary Outcomes (2)

  • Patency rate

    6 months

  • Creatinine level

    2 Days after PTA

Secondary Outcomes (5)

  • Mortality

    30 days

  • Days of Hospitalization

    12 months

  • Ankle-Brachial Index

    6 months and 12 months

  • walking distance

    6 months and 12 months

  • Restenosis rate

    12 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing PTA

You may qualify if:

  • Patients undergoing PTA

You may not qualify if:

  • \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Cardiology, Pulmonary Disease and Vascular Medicine

Düsseldorf, 40225, Germany

RECRUITING

Related Publications (2)

  • Baasen S, Stern M, Wischmann P, Schremmer J, Sansone R, Spieker M, Wolff G, Bonner F, Quast C, Heiss C, Kelm M, Busch L. Endovascular Treatment of Flow-Limiting Iliofemoral Stenosis Improves Left Ventricular Diastolic Function in Patients With HFpEF by Reducing Aortic Pulsatile Load. Circ Heart Fail. 2024 Sep;17(9):e011258. doi: 10.1161/CIRCHEARTFAILURE.123.011258. Epub 2024 Sep 9.

    PMID: 39247971DERIVED

  • Busch L, Heinen Y, Stern M, Wolff G, Ozaslan G, Tzetou K, Sansone R, Heiss C, Kelm M. Angioplasty of Flow-Limiting Stenosis Reduces Aortic and Brachial Blood Pressure in Patients With Peripheral Artery Disease. J Am Heart Assoc. 2021 Jul 20;10(14):e019724. doi: 10.1161/JAHA.120.019724. Epub 2021 Jul 6.

    PMID: 34227407DERIVED

Study Officials

  • Christian Heiss, MD

    Division of Cardiology, Pulmonary Disease and Vascular Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian Heiss, MD

CONTACT

+49 211 8118800christian.heiss@med.uni-duesseldorf.de

Rabea Wagstaff, BSc., M.A.

CONTACT

+49 211 8118800rabea.wagstaff@med.uni-duesseldorf.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Klinik für Kardiologie, Pneumologie und Angiologie

Study Record Dates

First Submitted

February 18, 2016

First Posted

April 5, 2016

Study Start

January 1, 2014

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Last Updated

February 7, 2020

Record last verified: 2020-02

Locations

DE(1)