Treatment of Acute Lower Limb Ischaemia in Sweden 1994-2014

NCT ID: NCT02835027

Last Updated: 2016-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

16287 participants

Study Classification

OBSERVATIONAL

Study Start Date

1994-01-31

Study Completion Date

2016-06-30

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.

Conditions

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Acute Ischemia of Lower Limb

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Open versus endovascular surgery

Treatment for acute ischemia

Intervention Type PROCEDURE

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uppsala University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Martin Bjorck

Professor of Vascular Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Martin Björck, Professor

Role: STUDY_DIRECTOR

Uppsala University

Other Identifiers

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Dnr2014/325

Identifier Type: -

Identifier Source: org_study_id

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