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Completed

NCT Number: NCT01877252

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

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

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Key information

Conditions

Critical Limb Ischemia Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Chronic Disease Chronic Limb-Threatening Ischemia Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Disease Attributes Endocrine System Diseases Foot Ulcer Ischemia Leg Ulcer Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Vascular Surgery, St. Franziskus Hospital

Münster, 48145, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgical revascularization

Procedure

Other names: Vein, PTFE, Dacron, Femoral artery patchplasty, Profunda patchplasty

Endovascular Revascularization

Procedure

Other names: Balloon angioplasty, Stent, Drug-eluting balloon, Drug-eluting stent, Lysis

No vascular intervention

Other

Other names: Major amputation, Minor amputation, Sympatholysis, Conservative treatment

Primary outcomes

  1. Amputation-free survival

    Time frame: at 2 years

    Above-ankle amputation of the index limb or death (any cause), whichever occurred first

Secondary outcomes

  1. Perioperative death

    Time frame: 30 days

  2. Major adverse limb event (MALE)

    Time frame: 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)

  3. Major adverse cardiovascular event (MACCE)

    Time frame: at 30 days, at 1 year, at 2 years

    myocardial infarction, stroke or death (any cause)

  4. Sustained clinical improvement

    Time frame: 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)

  5. Hemodynamic failure

    Time frame: 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

Sponsors and collaborators

Lead sponsor

St. Franziskus Hospital

Other

Collaborators

  • Deutsche Gesellschaft für Gefäßchirurgie und Gefäßmedizin
  • Deutsches Institut für Gefäßmedizinische Gesundheitsforschung gGmbH (DIGG)

Registry information

Official study title

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

Acronym: CRITISCH

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 13, 2013
Registry last updated
Nov 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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