Treatment of Acute Lower Limb Ischaemia in Sweden 1994-2014

Completed

• Conditions: Acute Ischemia of Lower Limb

• Registration Number: NCT02835027
• Lead Sponsor: Uppsala University Hospital

Brief Summary

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

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 Timeline

• Study Start: 1994-01
• Primary Completion: 2014-12
• Study Completion: 2016-06
• Status Verified: 2016-07
• Study First Submitted: 2016-07-13
• Study First Submitted QC: 2016-07-13
• Study First Posted: 2016-07-15
• Last Update Submitted: 2016-07-18
• Last Update Posted: 2016-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16287

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Amputation-free survival	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.

Secondary Outcome Measures

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