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

Completed

• Conditions: Critical Limb Ischemia
• Interventions: Procedure: Surgical revascularization; Procedure: Endovascular revascularization; Other: No vascular intervention

• Registration Number: NCT01877252
• Lead Sponsor: St. Franziskus Hospital

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 patients with critical limb ischemia

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 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 Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-05-20
• Study First Submitted QC: 2013-06-10
• Study First Posted: 2013-06-13
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-18
• Last Update Posted: 2014-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Open treatment	Surgical revascularization	Bypass (vein or prosthetic)
Patchplasty/Hybrid treatment	Surgical revascularization	Femoral artery patchplasty +/- profundoplasty +/- endovascular treatment
Endovascular treatment	Endovascular revascularization	Angioplasty +/- stent
Patchplasty/Hybrid treatment	Endovascular revascularization	Femoral artery patchplasty +/- profundoplasty +/- endovascular treatment
Conservative treatment	No vascular intervention	no vascular intervention

Primary Outcome Measures

Name	Time	Method
Amputation-free survival	at 2 years	Above-ankle amputation of the index limb or death (any cause), whichever occurred first

Secondary Outcome Measures

Name	Time	Method
Perioperative death	30 days
Major adverse cardiovascular event (MACCE)	at 30 days, at 1 year, at 2 years	myocardial infarction, stroke or death (any cause)
Hemodynamic failure	at 30 days, at 1 year, at 2 years	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
Sustained clinical improvement	at 1 year, at 2 years	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)
Major adverse limb event (MALE)	at 1 year, at 2 years	above ankle amputation of the index limb or major intervention (new bypass graft, jump/interposition graft revision, or thrombectomy/thrombolysis)

Trial Locations

Locations (1)

Department of Vascular Surgery, St. Franziskus Hospital; 🇩🇪 Muenster, Germany