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Completed

NCT Number: NCT03045224

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

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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Key information

Conditions

Efficacy/Long-term Effectiveness Endovascular Therapy in PAD Aortopulmonary Septal Defect Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Heart Septal Defects Truncus Arteriosus, Persistent

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PTA, balloon angioplasty, stent

Device

Primary outcomes

  1. death of any cause

    Time frame: 2 years

  2. revascularization (TLR, TVR)

    Time frame: 2 years

Secondary outcomes

  1. minor or major amputation

    Time frame: 2 years

  2. major adverse cardiac events and stroke

    Time frame: 2 years

  3. quality of life

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Vascular Center Berlin

Other

Collaborators

  • BVMed - The German Medical Technology Association
  • German Society for Angiology - Society for Vascular Medicine (DGA)

Registry information

Official study title

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

Acronym: PTAReg

Important dates

Study start
2008
Primary completion
2014
Study completion
2016
First posted
Feb 7, 2017
Registry last updated
Feb 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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