NCT01877252

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2013

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 13, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

November 19, 2014

Status Verified

November 1, 2014

Enrollment Period

1.7 years

First QC Date

May 20, 2013

Last Update Submit

November 18, 2014

Conditions

Critical Limb Ischemia

Keywords

critical limb ischemiaendovascular treatmentopen surgical repairdiabetic foot

Outcome Measures

Primary Outcomes (1)

  • Amputation-free survival

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

    at 2 years

Secondary Outcomes (5)

  • Perioperative death

    30 days

  • Major adverse limb event (MALE)

    at 1 year, at 2 years

  • Major adverse cardiovascular event (MACCE)

    at 30 days, at 1 year, at 2 years

  • Sustained clinical improvement

    at 1 year, at 2 years

  • Hemodynamic failure

    at 30 days, at 1 year, at 2 years

Study Arms (4)

Endovascular treatment

Angioplasty +/- stent

Procedure: Endovascular revascularization

Open treatment

Bypass (vein or prosthetic)

Procedure: Surgical revascularization

Patchplasty/Hybrid treatment

Femoral artery patchplasty +/- profundoplasty +/- endovascular treatment

Procedure: Surgical revascularizationProcedure: Endovascular revascularization

Conservative treatment

no vascular intervention

Other: No vascular intervention

Interventions

Surgical revascularizationPROCEDURE
Also known as: Vein, PTFE, Dacron, Femoral artery patchplasty, Profunda patchplasty
Open treatmentPatchplasty/Hybrid treatment
Endovascular revascularizationPROCEDURE
Also known as: Balloon angioplasty, Stent, Drug-eluting balloon, Drug-eluting stent, Lysis
Endovascular treatmentPatchplasty/Hybrid treatment
No vascular interventionOTHER
Also known as: Major amputation, Minor amputation, Sympatholysis, Conservative treatment
Conservative treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Rest pain or tissue loss (Fontaine stages III-IV or Rutherford classes 4 to 6) and/or ankle-brachial index \< 0.40

You may not qualify if:

  • Acute limb-threatening ischemia
  • Bone fractures in the relevant areas
  • Non-atherosclerotic disease (e.g. arteriitis)
  • Documented hypercoagulable diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Vascular Surgery, St. Franziskus Hospital

Münster, 48145, Germany

Location

Related Publications (12)

  • 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, Lepantalo 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.

    PMID: 22172473BACKGROUND

  • 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, Lepantalo 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.

    PMID: 22172472BACKGROUND

  • 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. doi: 10.1016/S0140-6736(05)67704-5.

    PMID: 16325694BACKGROUND

  • 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.

    PMID: 20435258BACKGROUND

  • 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.

    PMID: 19897335BACKGROUND

  • Stavroulakis K, Borowski M, Torsello G, Bisdas T; CRITISCH Collaborators. One-Year Results of First-Line Treatment Strategies in Patients With Critical Limb Ischemia (CRITISCH Registry). J Endovasc Ther. 2018 Jun;25(3):320-329. doi: 10.1177/1526602818771383. Epub 2018 Apr 26.

    PMID: 29968501DERIVED

  • Meyer A, Fiessler C, Stavroulakis K, Torsello G, Bisdas T, Lang W; CRITISCH collaborators. Outcomes of dialysis patients with critical limb ischemia after revascularization compared with patients with normal renal function. J Vasc Surg. 2018 Sep;68(3):822-829.e1. doi: 10.1016/j.jvs.2017.12.048. Epub 2018 Mar 26.

    PMID: 29598891DERIVED

  • Stavroulakis K, Borowski M, Torsello G, Bisdas T; CRITISCH collaborators. Association between statin therapy and amputation-free survival in patients with critical limb ischemia in the CRITISCH registry. J Vasc Surg. 2017 Nov;66(5):1534-1542. doi: 10.1016/j.jvs.2017.05.115. Epub 2017 Aug 12.

    PMID: 28807382DERIVED

  • Uhl C, Steinbauer M, Torsello G, Bisdas T; The CRITISCH collaborators. Outcomes After Endovascular Revascularization in Octogenarians and Non-Octogenarians With Critical Limb Ischemia. J Endovasc Ther. 2017 Aug 1;24(4):471-477. doi: 10.1177/1526602817711424. Epub 2017 Jun 5.

    PMID: 28578624DERIVED

  • Bisdas T, Borowski M, Stavroulakis K, Torsello G; CRITISCH Collaborators. Endovascular Therapy Versus Bypass Surgery as First-Line Treatment Strategies for Critical Limb Ischemia: Results of the Interim Analysis of the CRITISCH Registry. JACC Cardiovasc Interv. 2016 Dec 26;9(24):2557-2565. doi: 10.1016/j.jcin.2016.09.039.

    PMID: 28007205DERIVED

  • Meyer A, Lang W, Borowski M, Torsello G, Bisdas T; CRITISCH collaborators. In-hospital outcomes in patients with critical limb ischemia and end-stage renal disease after revascularization. J Vasc Surg. 2016 Apr;63(4):966-73. doi: 10.1016/j.jvs.2015.10.009. Epub 2016 Feb 1.

    PMID: 26843355DERIVED

  • Bisdas T, Borowski M, Torsello G; First-Line Treatments in Patients With Critical Limb Ischemia (CRITISCH) Collaborators. Current practice of first-line treatment strategies in patients with critical limb ischemia. J Vasc Surg. 2015 Oct;62(4):965-973.e3. doi: 10.1016/j.jvs.2015.04.441. Epub 2015 Jul 14.

    PMID: 26187290DERIVED

Related Links

MeSH Terms

Conditions

Chronic Limb-Threatening IschemiaDiabetic Foot

Interventions

PolytetrafluoroethylenePolyethylene TerephthalatesAngioplasty, BalloonStentsDrug-Eluting StentsConservative Treatment

Condition Hierarchy (Ancestors)

Peripheral Arterial DiseaseAtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsIschemiaDiabetic AngiopathiesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Intervention Hierarchy (Ancestors)

Fluorocarbon PolymersPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and AgriculturePolyestersAngioplastyCatheterizationTherapeuticsEndovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresInvestigative TechniquesProstheses and ImplantsEquipment and Supplies

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med.

Study Record Dates

First Submitted

May 20, 2013

First Posted

June 13, 2013

Study Start

January 1, 2013

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

November 19, 2014

Record last verified: 2014-11

Locations

DE(1)