Critical Limb IschemiaCRITISCHNCT01877252
Registry of First-line Treatments in Patients With Critical Limb Ischemia
An observational study of Critical Limb Ischemia, run by St. Franziskus Hospital at 1 site in Germany.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Limb Ischemia
- What is being tested?
- Surgical revascularization, Endovascular revascularization and No vascular intervention
- Type of treatment
- Surgery or procedure
- How many people
- 1,200 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2013to Sep 2014
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The target population consists of patients suffering from critical limb ischemia lasting more than 2 weeks
Who may be able to join
- Rest pain or tissue loss (Fontaine stages III-IV or Rutherford classes 4 to 6) and/or ankle-brachial index < 0.40
Who cannot join
- Acute limb-threatening ischemia
- Bone fractures in the relevant areas
- Non-atherosclerotic disease (e.g. arteriitis)
- Documented hypercoagulable diseases
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Vascular Surgery, St. Franziskus Hospital
Münster, 48145
About this study
Official title: National Registry Investigating the Effectiveness of Different First-line Treatment Strategies in Patients With Critical Limb Ischemia
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
Read the 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.
- Conditions
- Critical Limb Ischemia
- Being tested
- Surgical revascularization, Endovascular revascularization, No vascular intervention
- Keywords
- critical limb ischemia, endovascular treatment, open surgical repair, diabetic foot
- Medical subject headings
- Chronic Limb-Threatening Ischemia, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical revascularizationProcedure or surgery
Also called Vein, PTFE, Dacron, Femoral artery patchplasty
Endovascular revascularizationProcedure or surgery
Also called Balloon angioplasty, Stent, Drug-eluting balloon, Drug-eluting stent
No vascular interventionOther
Also called Major amputation, Minor amputation, Sympatholysis, Conservative treatment
| Study group | Role | What they receive |
|---|---|---|
| Endovascular treatment | Angioplasty +/- stent Receives: Procedure: Endovascular revascularization | |
| Open treatment | Bypass (vein or prosthetic) Receives: Procedure: Surgical revascularization | |
| Patchplasty/Hybrid treatment | Femoral artery patchplasty +/- profundoplasty +/- endovascular treatment Receives: Procedure: Surgical revascularization; Procedure: Endovascular revascularization | |
| Conservative treatment | no vascular intervention Receives: Other: No vascular intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amputation-free survival
Above-ankle amputation of the index limb or death (any cause), whichever occurred first
Measured: at 2 years
Secondary outcomes (5)
Perioperative death
Measured: 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)
Measured: at 1 year, at 2 years
Major adverse cardiovascular event (MACCE)
myocardial infarction, stroke or death (any cause)
Measured: 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)
Measured: 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
Measured: at 30 days, at 1 year, at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2013 (estimated)
- Study startJan 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Critical Limb IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- St. Franziskus Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsches Institut für Gefäßmedizinische Gesundheitsforschung gGmbH (DIGG), Deutsche Gesellschaft für Gefäßchirurgie und Gefäßmedizin
- Responsible party
- Principal investigator, Dr. Theodosios Bisdas, St. Franziskus Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01877252
- Sponsor's protocol ID
- CRITISCH132105
- Acronym
- CRITISCH
- Status last verified
- Nov 2014
- First submitted
- 20 May 2013
- Last updated
- 19 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22172473Becker 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.
PubMed 22172472Adam 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.
PubMed 16325694Bradbury 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.
PubMed 20435258Conte 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.
PubMed 19897335Stavroulakis 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.
PubMed 29968501Meyer 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.
PubMed 29598891Stavroulakis 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.
PubMed 28807382Uhl 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.
PubMed 28578624Bisdas 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.
PubMed 28007205Meyer 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.
PubMed 26843355Bisdas 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.
PubMed 26187290
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Registry Investigating the Effectiveness of Different First-line Treatment Strategies in Patients With Critical Limb Ischemia
- ClinicalTrials.gov ID
- NCT01877252
- Acronym / sponsor ID
- CRITISCH / CRITISCH132105
- Conditions
- Critical Limb Ischemia
- Keywords
- critical limb ischemia, endovascular treatment, open surgical repair, diabetic foot
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- St. Franziskus HospitalUniversity, hospital or other
- Collaborators
- Deutsches Institut für Gefäßmedizinische Gesundheitsforschung gGmbH (DIGG), Deutsche Gesellschaft für Gefäßchirurgie und Gefäßmedizin
- Study start
- Jan 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 13 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Endovascular treatment | – | Procedure: Endovascular revascularizationAngioplasty +/- stent |
| Open treatment | – | Procedure: Surgical revascularizationBypass (vein or prosthetic) |
| Patchplasty/Hybrid treatment | – | Procedure: Surgical revascularization, Procedure: Endovascular revascularizationFemoral artery patchplasty +/- profundoplasty +/- endovascular treatment |
| Conservative treatment | – | Other: No vascular interventionno vascular intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population consists of patients suffering from critical limb ischemia lasting more than 2 weeks
Key inclusion criteria (1 listed)
- Rest pain or tissue loss (Fontaine stages III-IV or Rutherford classes 4 to 6) and/or ankle-brachial index < 0.40
Key exclusion criteria (4 listed)
- Acute limb-threatening ischemia
- Bone fractures in the relevant areas
- Non-atherosclerotic disease (e.g. arteriitis)
- Documented hypercoagulable diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical revascularizationAlso: Vein, PTFE, Dacron, Femoral artery patchplasty | Procedure or surgery | Open treatment, Patchplasty/Hybrid treatment |
| Endovascular revascularizationAlso: Balloon angioplasty, Stent, Drug-eluting balloon, Drug-eluting stent | Procedure or surgery | Endovascular treatment, Patchplasty/Hybrid treatment |
| No vascular interventionAlso: Major amputation, Minor amputation, Sympatholysis, Conservative treatment | Other | Conservative treatment |
Primary outcome
Amputation-free survival
Time frame: at 2 years
Above-ankle amputation of the index limb or death (any cause), whichever occurred first
5 secondary outcomes
Perioperative death
Time frame: 30 days
Major adverse limb event (MALE)
Time frame: at 1 year, at 2 years
Major adverse cardiovascular event (MACCE)
Time frame: at 30 days, at 1 year, at 2 years
Sustained clinical improvement
Time frame: at 1 year, at 2 years
Hemodynamic failure
Time frame: at 30 days, at 1 year, at 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2014.
- Background: PubMed 22172473Setacci 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.
- Background: PubMed 22172472Becker 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.
- Background: PubMed 16325694Adam 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.
- Background: PubMed 20435258Bradbury 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.
- Background: PubMed 19897335Conte 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.
- Derived from this study: PubMed 29968501Stavroulakis 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.
- Derived from this study: PubMed 29598891Meyer 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.
- Derived from this study: PubMed 28807382Stavroulakis 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.
- Derived from this study: PubMed 28578624Uhl 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.
- Derived from this study: PubMed 28007205Bisdas 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.
- Derived from this study: PubMed 26843355Meyer 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.
- Derived from this study: PubMed 26187290Bisdas 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.
- German Society for Vascular Surgery and MedicineLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Limb Ischemia, run by St. Franziskus Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amputation-free survival (time frame: at 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01877252, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2014.