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

Critical Limb Ischemia Clinical Trial

— CRITISCH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01877252
• Other study ID #: CRITISCH132105
• Status: Completed
• Phase: N/A
• First received: May 20, 2013
• Last updated: November 18, 2014
• Start date: January 2013
• Est. completion date: September 2014

Study information

• Verified date: November 2014
• Source: St. Franziskus Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: German Society of Vascular Surgery and Medicine (DGG) and Deutsches Insitut für Gefäßmedizinische Gesundheitsforschung gGmbH (DIGG)
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Critical Limb Ischemia
• Ischemia

Intervention

Procedure:
• Surgical revascularization

• Endovascular revascularization

Other:
• No vascular intervention

Locations

Country	Name	City	State
Germany	Department of Vascular Surgery, St. Franziskus Hospital	Muenster

Sponsors (3)

Lead Sponsor	Collaborator
St. Franziskus Hospital	Deutsche Gesellschaft für Gefäßchirurgie und Gefäßmedizin, Deutsches Institut für Gefäßmedizinische Gesundheitsforschung gGmbH (DIGG)

Country where clinical trial is conducted

Germany, 

References & Publications (5)

Adam DJ, Beard JD, Cleveland T, Bell J, Bradbury AW, Forbes JF, Fowkes FG, Gillepsie I, Ruckley CV, Raab G, Storkey H; BASIL trial participants. Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial. Lancet. 2005 Dec 3;366(9501):1925-34. — View Citation

Becker F, Robert-Ebadi H, Ricco JB, Setacci C, Cao P, de Donato G, Eckstein HH, De Rango P, Diehm N, Schmidli J, Teraa M, Moll FL, Dick F, Davies AH, Lepäntalo M, Apelqvist J. Chapter I: Definitions, epidemiology, clinical presentation and prognosis. Eur J Vasc Endovasc Surg. 2011 Dec;42 Suppl 2:S4-12. doi: 10.1016/S1078-5884(11)60009-9. Review. — View Citation

Bradbury AW, Adam DJ, Bell J, Forbes JF, Fowkes FG, Gillespie I, Ruckley CV, Raab GM; BASIL trial Participants. Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial: An intention-to-treat analysis of amputation-free and overall survival in patients randomized to a bypass surgery-first or a balloon angioplasty-first revascularization strategy. J Vasc Surg. 2010 May;51(5 Suppl):5S-17S. doi: 10.1016/j.jvs.2010.01.073. Erratum in: J Vasc Surg. 2010 Dec;52(6):1751. Bhattachary, V [corrected to Bhattacharya, V]. — View Citation

Conte MS, Geraghty PJ, Bradbury AW, Hevelone ND, Lipsitz SR, Moneta GL, Nehler MR, Powell RJ, Sidawy AN. Suggested objective performance goals and clinical trial design for evaluating catheter-based treatment of critical limb ischemia. J Vasc Surg. 2009 Dec;50(6):1462-73.e1-3. doi: 10.1016/j.jvs.2009.09.044. Epub 2009 Nov 7. Review. — View Citation

Setacci C, de Donato G, Teraa M, Moll FL, Ricco JB, Becker F, Robert-Ebadi H, Cao P, Eckstein HH, De Rango P, Diehm N, Schmidli J, Dick F, Davies AH, Lepäntalo M, Apelqvist J. Chapter IV: Treatment of critical limb ischaemia. Eur J Vasc Endovasc Surg. 2011 Dec;42 Suppl 2:S43-59. doi: 10.1016/S1078-5884(11)60014-2. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amputation-free survival	Above-ankle amputation of the index limb or death (any cause), whichever occurred first	at 2 years	Yes
Secondary	Perioperative death		30 days	Yes
Secondary	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	Yes
Secondary	Major adverse cardiovascular event (MACCE)	myocardial infarction, stroke or death (any cause)	at 30 days, at 1 year, at 2 years	Yes
Secondary	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	No
Secondary	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	No

External Links

•   Department of Vascular Surgery, St. Franziskus Hospital
•   Deutsches Institut für Gefäßmedizinische Gesundheitsforschung (DIGG)
•   German Society for Vascular Surgery and Medicine