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

November 18, 2014 updated by: Dr. Theodosios Bisdas, St. Franziskus Hospital

National Registry Investigating the Effectiveness of Different First-line Treatment Strategies 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Muenster, Germany, 48145
        • Department of Vascular Surgery, St. Franziskus Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The target population consists of patients suffering from critical limb ischemia lasting more than 2 weeks

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Endovascular treatment
Angioplasty +/- stent
Procedure: Endovascular revascularization
Other Names:
  • Stent
  • Balloon angioplasty
  • Drug-eluting balloon
  • Drug-eluting stent
  • Lysis
Open treatment
Bypass (vein or prosthetic)
Procedure: Surgical revascularization
Other Names:
  • Vein
  • PTFE
  • Dacron
  • Femoral artery patchplasty
  • Profunda patchplasty
Patchplasty/Hybrid treatment
Femoral artery patchplasty +/- profundoplasty +/- endovascular treatment
Procedure: Endovascular revascularization
Other Names:
  • Stent
  • Balloon angioplasty
  • Drug-eluting balloon
  • Drug-eluting stent
  • Lysis
Procedure: Surgical revascularization
Other Names:
  • Vein
  • PTFE
  • Dacron
  • Femoral artery patchplasty
  • Profunda patchplasty
Conservative treatment
no vascular intervention
Other: No vascular intervention
Other Names:
  • Conservative treatment
  • Major amputation
  • Minor amputation
  • Sympatholysis

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Franziskus Hospital

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

May 20, 2013

First Submitted That Met QC Criteria

June 10, 2013

First Posted (Estimate)

June 13, 2013

Study Record Updates

Last Update Posted (Estimate)

November 19, 2014

Last Update Submitted That Met QC Criteria

November 18, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRITISCH132105

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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