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Treatment of Acute Lower Limb Ischaemia in Sweden 1994-2014

Treatment of Acute Lower Limb Ischaemia in Sweden 1994-2014

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02835027
Enrollment
16287
Registered
2016-07-15
Start date
1994-01-31
Completion date
2016-06-30
Last updated
2016-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Ischemia of Lower Limb

Keywords

Acute limb ischaemia(ALI), Acute ischaemia of the lower extremity, Thrombosis, Emboli, Endovascular surgery, Surgery, Amputation free survival, Long time survival, Demographics

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.

Interventions

PROCEDUREOpen versus endovascular surgery

Treatment for acute ischemia

Sponsors

Uppsala University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Amputation-free survival1-22 yearsCombined 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

MeasureTime frameDescription
Amputation1-22 yearsMajor amputation is defined as amputation above foot-level. Either the leg is amputated or not.
Survival1-22 yearsEither the patient is dead or alive
Complications 30 days after surgery30 daysBleeding, myocardial infarction, stroke, occlusion, compartment syndrome, etc

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026