Evaluation of acute and long-term outcomes of lysis therapy of arterial occlusions with tissue-specific plasminogen activator (rt-PA).
- Conditions
- I70.20
- Registration Number
- DRKS00030930
- Lead Sponsor
- niversitäts-Herzzentrum Freiburg-Bad Krozingen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 1238
Inclusion Criteria
All patients treated with lysis therapy for peripheral arterial disease of the lower extremities
Exclusion Criteria
- Patients in whom lysis therapy has not been used.
- Patients in whom lysis therapy has been used for recanalization of deep vein thrombosis or upper extremity vascular occlusion.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method -Peri-interventional complication rate defined as complications that affected therapy or required surgical or other correction, or prolonged hospital stay. Complications are divided into Serious Adverse Event (SAE) and (Adverse Event) AE. <br>- Acute Intervention Success, i.e., establishment of blood flow in the lysed vessel area defined as complete clearance of the occlusion or sufficient clearance to reveal an underlying etio- logical factor that was responsible for the occlusion.
- Secondary Outcome Measures
Name Time Method - Predictors of complication<br>- Leg preservation acutely and after 6, 12 and 24 months<br>- Re-intervention rate at the target lesion (target lesion revascularization, TLR) and at the target vessel (target vessel revascularization, TVR)<br>- Change in clinical symptoms using the Rutherford-Becker classification at 6, 12, and 24 months<br>- Change of the Ankle-Brachial-Index after 6, 12 and 24 months