- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02835027
Treatment of Acute Lower Limb Ischaemia in Sweden 1994-2014
Study of acute lower ischemia therapies based on data collected from the Swedish Vascular Surgery Registry between 1994 and 2014.
Primary endpoint is long term amputation-free survival and secondary end-points are 30 days and 1 year amputation-free survival as well as different revascularization techniques results and time trends.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The prospective Swedish Vascular Registry (Swedvasc) started in 1987 and since 1994 it has included more than 95 percent of the vascular surgical procedures performed nationwide. The registry has received extensive high internal and external validation. Roughly 16000 open surgical and endovascular revascularisation procedures for acute limb ischemia have been performed during this period of time.
The fact that every Swedish citizen has a unique personal identification number makes it possible to obtain 100 percent accurate survival and amputation data. Survival data were obtained through crosschecking the personal identification number with the national population registry in June 2016.
This offers a unique opportunity to study a large population-based cohort of unselected patients.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients with acute limb ischemia
- Surgical procedure performed between 1 January 1994 and 31 December 2014 in Sweden and registered in the Swedvasc registry
- Infrainguinal occlusions
Exclusion Criteria:
- Acute limb ischemia secondary to trauma, bleedings, dissection or graft infections.
- Suprainguinal occlusions.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Amputation-free survival
Time Frame: 1-22 years
|
Combined endpoint with death and amputation.
Either the leg is amputated and/or the patient is dead or the patient is alive without major amputation.
|
1-22 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Amputation
Time Frame: 1-22 years
|
Major amputation is defined as amputation above foot-level.
Either the leg is amputated or not.
|
1-22 years
|
Survival
Time Frame: 1-22 years
|
Either the patient is dead or alive
|
1-22 years
|
Complications 30 days after surgery
Time Frame: 30 days
|
Bleeding, myocardial infarction, stroke, occlusion, compartment syndrome, etc
|
30 days
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Martin Björck, Professor, Uppsala University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Dnr2014/325
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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