Treatment of Acute Lower Limb Ischaemia in Sweden 1994-2014

July 18, 2016 updated by: Martin Bjorck, Uppsala University Hospital

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.

Study Overview

Status

Completed

Conditions

Acute Ischemia of Lower Limb

Intervention / Treatment

Procedure: Open versus endovascular surgery

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 Type

Observational

Enrollment (Actual)

16287

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The entire Swedish population, thus no sampling.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1-22 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University Hospital

Investigators

Study Director: Martin Björck, Professor, Uppsala University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1994

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

July 13, 2016

First Submitted That Met QC Criteria