Status:
COMPLETED
Registry of First-line Treatments in Patients With Critical Limb Ischemia
Lead Sponsor:
St. Franziskus Hospital
Collaborating Sponsors:
Deutsches Institut für Gefäßmedizinische Gesundheitsforschung gGmbH (DIGG)
Deutsche Gesellschaft für Gefäßchirurgie und Gefäßmedizin
Conditions:
Critical Limb Ischemia
Eligibility:
All Genders
18+ years
Brief Summary
The principal research question is which treatment modality between open surgical, endovascular and conservative therapy is the most effective in terms of limb salvage, survival and reinterventions in...
Detailed Description
The target population consists of patients suffering from critical limb ischemia (CLI) lasting more than 2 weeks. CLI is defined as rest pain or tissue loss (Fontaine stages III-IV or Rutherford class...
Eligibility Criteria
Inclusion
- Rest pain or tissue loss (Fontaine stages III-IV or Rutherford classes 4 to 6) and/or ankle-brachial index \< 0.40
Exclusion
- Acute limb-threatening ischemia
- Bone fractures in the relevant areas
- Non-atherosclerotic disease (e.g. arteriitis)
- Documented hypercoagulable diseases
Key Trial Info
Start Date :
January 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT01877252
Start Date
January 1 2013
End Date
September 1 2014
Last Update
November 19 2014
Active Locations (1)
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1
Department of Vascular Surgery, St. Franziskus Hospital
Münster, Germany, 48145