PTA-Registry, a Prospective, Multicenter Study With 24-Month Follow-up

Endovascular Treatment in Patients With Peripheral Artery Disease: Real Life Effectiveness Off the Road of Studies PTA-Registry, a Prospective, Multicenter Study With 24-Month Follow-up

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03045224

Acronym

PTAReg

Enrollment

1760

Registered

2017-02-07

Start date

2008-08-31

Completion date

2016-09-30

Last updated

2017-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Efficacy/Long-term Effectiveness Endovascular Therapy in PAD

Keywords

PAD, PTA, mortality, morbidity, amputation rate, quality of life, Percutaneous transluminal angioplasty (PTA), Stenting, balloon angioplasty

Brief summary

The PTA-Registry (PTA-REG) is a prospective health services research registry to monitor and follow-up patients with peripheral arterial disease undergoing endovascular peripheral intervention. The PTA-REG has an interdisciplinary approach: cardiologists, angiologists, and radiologists contributed actively to this registry.

Detailed description

The registry was created for the following purposes: evaluation of the clinical effectiveness, safety and quality of the endovascular therapy, and history of the disease after endovascular therapy. The resulting specific research questions were determination of the technical and clinical success of the procedure, monitoring of periinterventional complications, evaluation of vessel patency, amputation rate, mortality, and major adverse cardiac events during the follow-up. In addition, the quality of life after endovascular peripheral intervention over a period of two years was evaluated.

Interventions

DEVICEPTA, balloon angioplasty, stent

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* peripheral arterial disease of the iliac and lower extremity arteries and appropriate clinical indication for treatment with PTA according to current guidelines

Exclusion criteria

* no

Design outcomes

Primary

Measure	Time frame
death of any cause	2 years
revascularization (TLR, TVR)	2 years

Secondary

Measure	Time frame	Description
minor or major amputation	2 years	—
major adverse cardiac events and stroke	2 years	—
quality of life	2 years	The follow-up was performed at months 6, 12, 18, and 24. The follow-up consisted of a quality of life questionnaire (EQ-5D)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026