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 patients with critical limb ischemia
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 classes 4 to 6) and/or ankle-brachial index \< 0.40. Patient with acute limb-threatening ischemia, bone fractures in the relevant areas, nonatherosclerotic disease (e.g. arteriitis) and documented hypercoagulable diseases will be excluded from this study. There will be no experimental or control groups. The comparison groups will be: Group 1: Best endovascular treatment (angioplasty +/- stent) Group 2: Best surgical treatment \[bypass (vein or prosthetic)\] Group 3: Femoral artery patchplasty +/- profundoplasty (+/- endovascular treatment) Group 4: Best conservative treatment The proposed sample size amounts to 1200 patients. To be assessed for eligibility (n=1200) To be allocated to trial (n=1000) To be analysed (n=900) In CRITISCH registry, randomization or blinding is not feasible, because optimized standard care will be performed as established at each participating centre (best medical treatment). Data storage, validation, monitoring, update, backup and analysis will be performed centrally following established procedures. Web-based software will be used to develop a data model representing the data structure. The data validation will include standard data validation techniques such as the manual review of selected variables and the routine check of missing and outlying data points. Regional staff will be instructed and supervised by study nurse, who will perform the study monitoring. Assessment of relevant prognostic factors during the statistical analysis will prevent biased results due to the non-randomized design and the potential structural inequality.
Study Type
OBSERVATIONAL
Enrollment
1,200
Department of Vascular Surgery, St. Franziskus Hospital
Münster, Germany
Amputation-free survival
Above-ankle amputation of the index limb or death (any cause), whichever occurred first
Time frame: at 2 years
Perioperative death
Time frame: 30 days
Major adverse limb event (MALE)
above ankle amputation of the index limb or major intervention (new bypass graft, jump/interposition graft revision, or thrombectomy/thrombolysis)
Time frame: at 1 year, at 2 years
Major adverse cardiovascular event (MACCE)
myocardial infarction, stroke or death (any cause)
Time frame: at 30 days, at 1 year, at 2 years
Sustained clinical improvement
upward shift on the Rutherford or Fontaine classification to a level of intermittent claudication in amputation-free surviving patients without the need for repeated target lesion revascularization (TLR) (primary improvement) or after repeated TLR (secondary improvement)
Time frame: at 1 year, at 2 years
Hemodynamic failure
first occurrence of any of the following events in a time-to-event fashion: (a) major amputation (transtibial or above) and/or (b) reintervention to maintain vascular patency in the index limb and/or (c) failure to increase ankle-brachial-index (ABI) by at least 0.15 postprocedure\] and/or (d) decrease in ABI by 0.15
Time frame: at 30 days, at 1 year, at 2 years
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