Contact information
Type
Scientific
Primary contact
Prof Friedhelm Beyersdorf
ORCID ID
Contact details
Department of Cardiovascular Surgery
University Hospital Freiburg
Hugstetterstr. 55
Freiburg
79106
Germany
+49 761 2702818
beyers@chir.ukl.uni-freiburg.de
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
NCT00567801
Protocol/serial number
S 991228
Study information
Scientific title
Randomised, controlled multicentre-trial for the optimised therapy of the acutely ischaemic limb with controlled reperfusion
Acronym
CRAIL
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Acutely ischaemic limb
Intervention
Embolectomy/Thrombectomy vs controlled reperfusion after Embolectomy/Thrombectomy
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2004
Overall trial end date
31/12/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patient >18 years
2. Acute arterial occlusion of one or both lower limbs (Rutherford IIa-III)
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
Not provided at time of registration
Total final enrolment
174
Participant exclusion criteria
1. Patients having undergone an attempt at recanalisation (Lyse etc.)
2. Heart failure (New York Heart Association [NYHA] IV)
3. Terminal kidney failure
4. Patients with a known aneurysm of the arteria poplitea
Recruitment start date
01/01/2004
Recruitment end date
31/12/2007
Locations
Countries of recruitment
Germany
Trial participating centre
Department of Cardiovascular Surgery
Freiburg
79106
Germany
Sponsor information
Organisation
University Hospital Freiburg (Germany)
Sponsor details
Department of Cardiovascular Surgery
University Hospital Freiburg
Hugstetterstr.55
Freiburg
79106
Germany
+49 761 2702818
beyers@chir.ukl.uni-freiburg.de
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Deutsche Forschungsgemeinschaft, Bonn, Germany
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Dr. Köhler-Chemie, Alsbach-Hähnlein, Germany
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Local research commission, University hospital Freiburg, Germany
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2005 preliminary study on http://www.ncbi.nlm.nih.gov/pubmed/16242556
2. 2013 results in: https://www.ncbi.nlm.nih.gov/pubmed/23881815 (added 31/05/2019)
Publication citations
-
Preliminary study
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, 42, 4, 690-694, doi: 10.1016/j.jvs.2005.05.055.