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Completed

NCT Number: 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.

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Key information

Conditions

Acute Ischemia of Lower Limb Cardiovascular Diseases Embolism Embolism and Thrombosis Thrombosis Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Open versus endovascular surgery

Procedure

Treatment for acute ischemia

Primary outcomes

  1. 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.

Secondary outcomes

  1. Amputation

    Time frame: 1-22 years

    Major amputation is defined as amputation above foot-level. Either the leg is amputated or not.

  2. Survival

    Time frame: 1-22 years

    Either the patient is dead or alive

  3. Complications 30 days after surgery

    Time frame: 30 days

    Bleeding, myocardial infarction, stroke, occlusion, compartment syndrome, etc

Sponsors and collaborators

Lead sponsor

Uppsala University Hospital

Other

Registry information

Important dates

Study start
1994
Primary completion
2014
Study completion
2016
First posted
Jul 15, 2016
Registry last updated
Jul 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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