Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Deutsches Institut für Gefäßmedizinische Gesundheitsforschung gGmbH (DIGG) | UNKNOWN |
| Deutsche Gesellschaft für Gefäßchirurgie und Gefäßmedizin | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endovascular treatment | Angioplasty +/- stent |
| |
| Open treatment | Bypass (vein or prosthetic) |
| |
| Patchplasty/Hybrid treatment | Femoral artery patchplasty +/- profundoplasty +/- endovascular treatment |
| |
| Conservative treatment | no vascular intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical revascularization | Procedure |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Amputation-free survival | Above-ankle amputation of the index limb or death (any cause), whichever occurred first | at 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative death | 30 days | |
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
The target population consists of patients suffering from critical limb ischemia lasting more than 2 weeks
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Vascular Surgery, St. Franziskus Hospital | Münster | 48145 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22172473 | Background | 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. | |
| 22172472 | Background |
| Label | URL |
|---|---|
| German Society for Vascular Surgery and Medicine | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D000089802 | Chronic Limb-Threatening Ischemia |
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D011138 | Polytetrafluoroethylene |
| D011093 | Polyethylene Terephthalates |
| D000800 | Angioplasty, Balloon |
| D015607 | Stents |
| D054855 | Drug-Eluting Stents |
| D000072700 | Conservative Treatment |
| ID | Term |
|---|---|
| D005465 | Fluorocarbon Polymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
Not provided
Not provided
Not provided
Not provided
Not provided
| Endovascular revascularization | Procedure |
|
|
| No vascular intervention | Other |
|
|
| at 1 year, at 2 years |
| Major adverse cardiovascular event (MACCE) | myocardial infarction, stroke or death (any cause) | at 30 days, at 1 year, at 2 years |
| 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 |
| 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 |
| 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. |
| 16325694 | Background | 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. |
| 20435258 | Background | 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. |
| 19897335 | Background | 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. |
| 29968501 | Derived | 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. |
| 29598891 | Derived | 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. |
| 28807382 | Derived | 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. |
| 28578624 | Derived | 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. |
| 28007205 | Derived | 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. |
| 26843355 | Derived | 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. |
| 26187290 | Derived | 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. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007511 | Ischemia |
| D003925 | Diabetic Angiopathies |
| D016523 | Foot Ulcer |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D011091 | Polyesters |
| D017130 | Angioplasty |
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |