Registry of First-line Treatments in Patients With Critical Limb Ischemia

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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National Registry Investigating the Effectiveness of Different First-line Treatment Strategies in Patients With Critical Limb Ischemia

Conditions
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Critical Limb Ischemia

Intervention / Treatment
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* Procedure: Surgical revascularization
* Procedure: Endovascular revascularization
* Other: No vascular intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Rest pain or tissue loss (Fontaine stages III-IV or Rutherford classes 4 to 6) and/or ankle-brachial index < 0.40 Exclusion Criteria: Acute limb-threatening ischemia Bone fractures in the relevant areas Non-atherosclerotic disease (e.g. arteriitis) Documented hypercoagulable diseases

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Endovascular treatment<br>Angioplasty +/- stent | Procedure: Endovascular revascularization<br> <br> * Other names: Lysis;|
| Open treatment<br>Bypass (vein or prosthetic) | Procedure: Surgical revascularization<br> <br> * Other names: Profunda patchplasty;|
| Patchplasty/Hybrid treatment<br>Femoral artery patchplasty +/- profundoplasty +/- endovascular treatment | Procedure: Surgical revascularization<br> <br> * Other names: Profunda patchplasty;Procedure: Endovascular revascularization<br> <br> * Other names: Lysis;|
| Conservative treatment<br>no vascular intervention | Other: No vascular intervention<br> <br> * Other names: Conservative treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amputation-free survival | Above-ankle amputation of the index limb or death (any cause), whichever occurred first | at 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative death |  | 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) | at 1 year, at 2 years | 
| Major adverse cardiovascular event (MACCE) | myocardial infarction, stroke or death (any cause) | 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) | 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 | at 30 days, at 1 year, at 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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critical limb ischemia, endovascular treatment, open surgical repair, diabetic foot