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

NCT03045224 — Completed, 1760 participants, Vascular Center Berlin

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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

Registry	NCT03045224, acronym PTAReg
Status	Completed
Study type	Observational
Enrollment	1760 (Actual)
Sponsor	Vascular Center Berlin (Other); collaborators: BVMed - The German Medical Technology Association, German Society for Angiology - Society for Vascular Medicine (DGA)
Conditions	Efficacy/Long-term Effectiveness Endovascular Therapy in PAD
Interventions	PTA, balloon angioplasty, stent (Device)
Dates	start 2008-08-01, primary completion 2014-08-01, completion 2016-09-01, first posted 2017-02-07, last updated 2017-02-09

-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.

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+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.

+Arms and interventions

PTA, balloon angioplasty, stent (Device)

+Outcome measures

Primary outcomes

death of any cause [2 years]
revascularization (TLR, TVR) [2 years]

Secondary outcomes

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)

+Eligibility

Sex: All, ages: 18 Years to any

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 exclusion criteria and no age restriction