Treatment of Acute Lower Limb Ischaemia in Sweden 1994-2014

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Treatment of Acute Lower Limb Ischaemia in Sweden 1994-2014

Conditions
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Acute Ischemia of Lower Limb

Intervention / Treatment
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* Procedure: Open versus endovascular surgery


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Open versus endovascular surgery|Treatment for acute ischemia|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amputation-free survival | 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 | Major amputation is defined as amputation above foot-level. Either the leg is amputated or not. | 1-22 years | 
| Survival | Either the patient is dead or alive | 1-22 years | 
| Complications 30 days after surgery | Bleeding, myocardial infarction, stroke, occlusion, compartment syndrome, etc | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute limb ischaemia(ALI), Acute ischaemia of the lower extremity, Thrombosis, Emboli, Endovascular surgery, Surgery, Amputation free survival, Long time survival, Demographics