PTA-Registry, a Prospective, Multicenter Study With 24-Month Follow-up
- Conditions
- Efficacy/Long-term Effectiveness Endovascular Therapy in PAD
- Registration Number
- NCT03045224
- Lead Sponsor
- Vascular Center Berlin
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1760
- peripheral arterial disease of the iliac and lower extremity arteries and appropriate clinical indication for treatment with PTA according to current guidelines
- no exclusion criteria and no age restriction
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method death of any cause 2 years revascularization (TLR, TVR) 2 years
- Secondary Outcome Measures
Name Time Method 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)
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