National Registry Investigating the Effectiveness of Different First-line Treatment Strategies in Patients With Critical Limb Ischemia
Registry of First-line Treatments in Patients With Critical Limb Ischemia
Sponsors
Source
St. Franziskus Hospital
Oversight Info
Has Dmc
Yes
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
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.
Overall Status
Completed
Start Date
2013-01-01
Completion Date
2014-09-01
Primary Completion Date
2014-09-01
Study Type
Observational [Patient Registry]
Primary Outcome
Measure |
Time Frame |
|
Amputation-free survival |
at 2 years |
Secondary Outcome
Measure |
Time Frame |
|
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 |
Number Of Groups
4
Enrollment
1200
Condition
Intervention
Intervention Type
Procedure
Intervention Name
Arm Group Label
Open treatment
Patchplasty/Hybrid treatment
Other Name
Vein
PTFE
Dacron
Femoral artery patchplasty
Profunda patchplasty
Intervention Type
Procedure
Intervention Name
Arm Group Label
Endovascular treatment
Patchplasty/Hybrid treatment
Other Name
Balloon angioplasty
Stent
Drug-eluting balloon
Drug-eluting stent
Lysis
Intervention Type
Other
Intervention Name
Arm Group Label
Conservative treatment
Other Name
Major amputation
Minor amputation
Sympatholysis
Conservative treatment
Eligibility
Study Pop
The target population consists of patients suffering from critical limb ischemia lasting
more than 2 weeks
Sampling Method
Probability Sample
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
Gender
All
Minimum Age
18 Years
Maximum Age
N/A
Healthy Volunteers
No
Location
Facility |
|
Department of Vascular Surgery, St. Franziskus Hospital Muenster 48145 Germany |
Location Countries
Country
Germany
Verification Date
2014-11-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
St. Franziskus Hospital
Investigator Full Name
Dr. Theodosios Bisdas
Investigator Title
Dr. med.
Keywords
Has Expanded Access
No
Condition Browse
Arm Group
Arm Group Label
Endovascular treatment
Description
Angioplasty +/- stent
Arm Group Label
Open treatment
Description
Bypass (vein or prosthetic)
Arm Group Label
Patchplasty/Hybrid treatment
Description
Femoral artery patchplasty +/- profundoplasty +/- endovascular treatment
Arm Group Label
Conservative treatment
Description
no vascular intervention
Firstreceived Results Date
N/A
Reference
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.
PMID
22172473
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.
PMID
22172472
Citation
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.
PMID
16325694
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].
PMID
20435258
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.
PMID
19897335
Acronym
CRITISCH
Target Duration
2 Years
Firstreceived Results Disposition Date
N/A
Study Design Info
Observational Model
Cohort
Time Perspective
Prospective
Study First Submitted
May 20, 2013
Study First Submitted Qc
June 10, 2013
Study First Posted
June 13, 2013
Last Update Submitted
November 18, 2014
Last Update Submitted Qc
November 18, 2014
Last Update Posted
November 19, 2014
ClinicalTrials.gov processed this data on August 24, 2018
Conditions
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Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.