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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Efficacy/Long-term Effectiveness Endovascular Therapy in PAD
- Sponsor
- Vascular Center Berlin
- Enrollment
- 1760
- Primary Endpoint
- death of any cause
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Prof. Dr. K.-L. Schulte
Head of Vascular Center Berlin
Vascular Center Berlin
Eligibility Criteria
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
Outcomes
Primary Outcomes
death of any cause
Time Frame: 2 years
revascularization (TLR, TVR)
Time Frame: 2 years
Secondary Outcomes
- minor or major amputation(2 years)
- major adverse cardiac events and stroke(2 years)
- quality of life(2 years)