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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by St. Franziskus Hospital
Sponsor:
Collaborators:
Deutsches Institut für Gefäßmedizinische Gesundheitsforschung gGmbH (DIGG)
Deutsche Gesellschaft für Gefäßchirurgie und Gefäßmedizin
Information provided by (Responsible Party):
Dr. Theodosios Bisdas, St. Franziskus Hospital
ClinicalTrials.gov Identifier:
NCT01877252
First received: May 20, 2013
Last updated: June 10, 2013
Last verified: June 2013
  Purpose

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


Condition Intervention
Critical Limb Ischemia
Procedure: Surgical revascularization
Procedure: Endovascular revascularization
Other: No vascular intervention

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: National Registry Investigating the Effectiveness of Different First-line Treatment Strategies in Patients With Critical Limb Ischemia

Resource links provided by NLM:


Further study details as provided by St. Franziskus Hospital:

Primary Outcome Measures:
  • Amputation-free survival [ Time Frame: at 2 years ] [ Designated as safety issue: Yes ]
    Above-ankle amputation of the index limb or death (any cause), whichever occurred first


Secondary Outcome Measures:
  • Perioperative death [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Major adverse limb event (MALE) [ Time Frame: at 1 year, at 2 years ] [ Designated as safety issue: Yes ]
    above ankle amputation of the index limb or major intervention (new bypass graft, jump/interposition graft revision, or thrombectomy/thrombolysis)

  • Major adverse cardiovascular event (MACCE) [ Time Frame: at 30 days, at 1 year, at 2 years ] [ Designated as safety issue: Yes ]
    myocardial infarction, stroke or death (any cause)

  • Sustained clinical improvement [ Time Frame: at 1 year, at 2 years ] [ Designated as safety issue: No ]
    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)

  • Hemodynamic failure [ Time Frame: at 30 days, at 1 year, at 2 years ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 1200
Study Start Date: January 2013
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Endovascular treatment
Angioplasty +/- stent
Procedure: Endovascular revascularization
Other Names:
  • Balloon angioplasty
  • Stent
  • 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: Surgical revascularization
Other Names:
  • Vein
  • PTFE
  • Dacron
  • Femoral artery patchplasty
  • Profunda patchplasty
Procedure: Endovascular revascularization
Other Names:
  • Balloon angioplasty
  • Stent
  • Drug-eluting balloon
  • Drug-eluting stent
  • Lysis
Conservative treatment
no vascular intervention
Other: No vascular intervention
Other Names:
  • Major amputation
  • Minor amputation
  • Sympatholysis
  • Conservative 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01877252

Contacts
Contact: Theodosios Bisdas, MD +492518345782 theodosios.bisdas@ukmuenster.de
Contact: Giovanni Torsello, MD, PhD +492518345782 giovanni.torsello@ukmuenster.de

Locations
Germany
Department of Vascular Surgery, St. Franziskus Hospital Recruiting
Muenster, Germany, 48145
Contact: Theodosios Bisdas, MD    +492518345782    theodosios.bisdas@ukmuenster.de   
Sponsors and Collaborators
St. Franziskus Hospital
Deutsches Institut für Gefäßmedizinische Gesundheitsforschung gGmbH (DIGG)
Deutsche Gesellschaft für Gefäßchirurgie und Gefäßmedizin
  More Information

Additional Information:
Publications:

Responsible Party: Dr. Theodosios Bisdas, Dr. med., St. Franziskus Hospital
ClinicalTrials.gov Identifier: NCT01877252     History of Changes
Other Study ID Numbers: CRITISCH132105
Study First Received: May 20, 2013
Last Updated: June 10, 2013
Health Authority: Germany: German Society of Vascular Surgery and Medicine (DGG) and Deutsches Insitut für Gefäßmedizinische Gesundheitsforschung gGmbH (DIGG)

Keywords provided by St. Franziskus Hospital:
critical limb ischemia
endovascular treatment
open surgical repair
diabetic foot

Additional relevant MeSH terms:
Ischemia
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014