Lower Extremity IschemiaPhase 3CRAILNCT00567801
CRAIL - Controlled Reperfusion of the Acutely Ischemic Limb
A Phase 3 study testing conventional embolectomy/thrombectomy in people with Lower Extremity Ischemia, run by University Hospital Freiburg at 23 sites in 2 countries.
Trial summary
The purpose of this study is to prove the findings of a preliminary study which strongly suggest the hypothesis that the result of conventional embolectomy for acute, severe lower-limb ischemia can be improved by controlled reperfusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Extremity Ischemia
- What is being tested?
- conventional embolectomy/thrombectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 23 sitesin 2 countries
- Study dates
- Sep 2002to Sep 2010
- Phase
- Phase 3
- 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
Who may be able to join
- Patients aged 18 years or older
- Patients with arterial occlusion of one or both lower limbs with acute decompensated ischemia (Rutherford IIA to III)
- Informed consent of the patient
Who cannot join
- Previous attempt of recanalisation (e.g. lysis therapy)
- Known A. poplitea aneurysm of the affected extremity
- Severe heart failure NYHA IV
- Known atrial thrombus
- Terminal renal insufficiency (creatinine >10mg/dl or current dialysis therapy, previous transplantation of kidney)
- Hypersensitivity to allopurinol
Show all 11Show fewer
- Hypersensitivity to one component part of the reperfusion solution
- Participation in a clinical trial during the study or 30 days before
- Pregnancy or lactation
- Patient incapable of contracting or not able to understand the character, meaning and consequences of the clinical trial
- Abuse to drugs or alcohol
Trial locations and contacts
23 sites in 2 countries.
23 sites in 2 countries
Germany21 sites
Herzzentrum Bad Krozingen
Bad Krozingen
Universitätsklinikum Bonn
Bonn
Kreisklinikum Donaueschingen
Donaueschingen
St. Johannes-Hospital Dortmund
Dortmund
Marienhospital Altenessen
Essen
Universitätsklinikum Frankfurt
Frankfurt
University Medical Center Freiburg
Freiburg im Breisgau, Baden-Wurttemberg
St. Marien-Hospital Buer, Gelsenkirchen
Gelsenkirchen
Universitätsklinikum Giessen
Giessen
Herzzentrum Göttingen
Göttingen
Uniklinik Hamburg-Eppendorf
Hamburg
Städtisches Klinikum Karlsruhe
Karlsruhe, Baden-Wurttemberg
Universitätsklinikum Kiel
Kiel
Klinikum Lahr
Lahr, Baden-Wurttemberg
Park-Krankenhaus Leipzig
Leipzig
Universitätsklinikum Lübeck
Lübeck
Universitätsklinikum Mainz
Mainz
Klinikum E. v. Bergmann Potsdam
Potsdam
Universitätsklinikum Rostock
Rostock
Hegau-Klinikum Singen
Singen
Klinikum Villingen-Schwenningen
Villingen-Schwenningen, Baden-Wurttemberg
Austria2 sites
Universität Innsbruck
Innsbruck
St. Johanns-Spital Salzburg
Salzburg
About this study
Official title: Prospektive, Randomisierte Multicenter-Studie Zur Optimierung Der Therapie Der Akuten Ischämie Der Unteren Extremitäten Durch Die Kontrollierte Extremitätenreperfusion (Prospective, Randomized Multicenter - Study for Optimization of Therapy of the Acute Ischemic Limb by Controlled Reperfusion)
The purpose of this study is to prove the findings of a preliminary study which strongly suggest the hypothesis that the result of conventional embolectomy for acute, severe lower-limb ischemia can be improved by controlled reperfusion.
- Conditions
- Lower Extremity Ischemia
- Being tested
- conventional embolectomy/thrombectomy, embolectomy/thrombectomy with controlled reperfusion
- Keywords
- Lower Extremity, Ischemia
- Medical subject headings
- Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional embolectomy/thrombectomyProcedure or surgery
embolectomy/thrombectomy with controlled reperfusionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | conventional embolectomy/thrombectomy Receives: Procedure: conventional embolectomy/thrombectomy |
| 2 | Experimental | embolectomy/thrombectomy with controlled reperfusion Receives: Procedure: embolectomy/thrombectomy with controlled reperfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amputation-free survival
Measured: 28 days
Secondary outcomes (4)
Neurological status (motor function, sensor function) of ischemic limb
Measured: 4 weeks
Systemic complications in both therapy groups
Measured: 4 weeks
Tolerance of reperfusion solution
Measured: 4 weeks
Lethality
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2007 (estimated)
- Study startSep 2002
- Primary completionSep 2009 (estimated)
- Study completionSep 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lower Extremity 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Freiburg
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Köhler Chemie (Alsbach-Hähnlein, Germany), HP-Medica (Augsburg, Germany), GEA (Frederiksberg, Denmark), Kardialagut (München, Germany)
- Investigators
- Friedhelm Beyersdorf, Prof. Dr., Principal investigator, Department of Cardiovascular Surgery, University Medical Center Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00567801
- Sponsor's protocol ID
- S 991228
- Acronym
- CRAIL
- Status last verified
- Jul 2008
- First submitted
- 4 Dec 2007
- Last updated
- 28 Jul 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wilhelm MP, Schlensak C, Hoh A, Knipping L, Mangold G, Dallmeier Rojas D, Beyersdorf F. Controlled reperfusion using a simplified perfusion system preserves function after acute and persistent limb ischemia: a preliminary study. J Vasc Surg. 2005 Oct;42(4):690-4. doi: 10.1016/j.jvs.2005.05.055.
PubMed 16242556
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospektive, Randomisierte Multicenter-Studie Zur Optimierung Der Therapie Der Akuten Ischämie Der Unteren Extremitäten Durch Die Kontrollierte Extremitätenreperfusion (Prospective, Randomized Multicenter - Study for Optimization of Therapy of the Acute Ischemic Limb by Controlled Reperfusion)
- ClinicalTrials.gov ID
- NCT00567801
- Acronym / sponsor ID
- CRAIL / S 991228
- Conditions
- Lower Extremity Ischemia
- Keywords
- Lower Extremity, Ischemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University Hospital FreiburgUniversity, hospital or other
- Collaborators
- Dr. Köhler Chemie (Alsbach-Hähnlein, Germany), HP-Medica (Augsburg, Germany), GEA (Frederiksberg, Denmark), Kardialagut (München, Germany)
- Study start
- Sep 2002
- Primary completion
- Sep 2009 (estimated)
- Study completion
- Sep 2010 (estimated)
- First posted
- 5 Dec 2007 (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 purpose of this study is to prove the findings of a preliminary study which strongly suggest the hypothesis that the result of conventional embolectomy for acute, severe lower-limb ischemia can be improved by controlled reperfusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: conventional embolectomy/thrombectomyconventional embolectomy/thrombectomy |
| 2 | Experimental | Procedure: embolectomy/thrombectomy with controlled reperfusionembolectomy/thrombectomy with controlled reperfusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18 years or older
- Patients with arterial occlusion of one or both lower limbs with acute decompensated ischemia (Rutherford IIA to III)
- Informed consent of the patient
Key exclusion criteria (11 listed)
- Previous attempt of recanalisation (e.g. lysis therapy)
- Known A. poplitea aneurysm of the affected extremity
- Severe heart failure NYHA IV
- Known atrial thrombus
- Terminal renal insufficiency (creatinine >10mg/dl or current dialysis therapy, previous transplantation of kidney)
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 |
|---|---|---|
| conventional embolectomy/thrombectomy | Procedure or surgery | 1 |
| embolectomy/thrombectomy with controlled reperfusion | Procedure or surgery | 2 |
Primary outcome
Amputation-free survival
Time frame: 28 days
4 secondary outcomes
Neurological status (motor function, sensor function) of ischemic limb
Time frame: 4 weeks
Systemic complications in both therapy groups
Time frame: 4 weeks
Tolerance of reperfusion solution
Time frame: 4 weeks
Lethality
Time frame: 12 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2008.
- Background: PubMed 16242556Wilhelm MP, Schlensak C, Hoh A, Knipping L, Mangold G, Dallmeier Rojas D, Beyersdorf F. Controlled reperfusion using a simplified perfusion system preserves function after acute and persistent limb ischemia: a preliminary study. J Vasc Surg. 2005 Oct;42(4):690-4. doi: 10.1016/j.jvs.2005.05.055.
Related trials for Lower Extremity Ischemia
Recruiting
Effectiveness of Theta Burst Stimulation For Upper and Lower Extremity Recovery in Stroke
Ischemic Stroke
Recruiting
Postural Mobilization Compared to Noradrenaline Only in Off-Pump CABG Surgery
Coronary Artery Disease With Need for Bypass Surgery, Coronary Artery Disease(CAD)
Not yet recruiting
Nasal High Flow Oxygen in Patients With Lower-Limb Ischaemia
Lower Limb Ischaemia
Recruiting
The ArtixASCEND Study
Acute Lower Limb Arterial Occlusion
Not yet recruiting
Determining the Effects of Ischemic Conditioning and Neuromuscular Electrical Stimulation on Overall Function After Lower Limb Amputation
Lower Limb Amputation Above Knee, Below Knee Amputation
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.
Friedhelm Beyersdorf, Prof. Dr. principal investigator
Department of Cardiovascular Surgery, University Medical Center Freiburg
23 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing conventional embolectomy/thrombectomy in people with Lower Extremity Ischemia, run by University Hospital Freiburg at 23 sites in 2 countries.
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 3 inclusion and 11 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: stopped early, as of the sponsor's last update on 28 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Germany, Austria. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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: 28 days). 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 NCT00567801, which also lists 1 linked publication.
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 28 Jul 2008.