NCT02835027

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16,287

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 1994

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1994

Completed
20.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 13, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 15, 2016

Completed
Last Updated

July 19, 2016

Status Verified

July 1, 2016

Enrollment Period

20.9 years

First QC Date

July 13, 2016

Last Update Submit

July 18, 2016

Conditions

Acute Ischemia of Lower Limb

Keywords

Acute limb ischaemia(ALI)Acute ischaemia of the lower extremityThrombosisEmboliEndovascular surgerySurgeryAmputation free survivalLong time survivalDemographics

Outcome Measures

Primary Outcomes (1)

  • Amputation-free survival

    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 Outcomes (3)

  • Amputation

    1-22 years

  • Survival

    1-22 years

  • Complications 30 days after surgery

    30 days

Interventions

Open versus endovascular surgeryPROCEDURE

Treatment for acute ischemia

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The entire Swedish population, thus no sampling.

You may qualify if:

  • 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

You may not qualify if:

  • Acute limb ischemia secondary to trauma, bleedings, dissection or graft infections.
  • Suprainguinal occlusions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ThrombosisEmbolism

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Martin Björck, Professor

    Uppsala University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
22 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Vascular Surgery

Study Record Dates

First Submitted

July 13, 2016

First Posted

July 15, 2016

Study Start

January 1, 1994

Primary Completion

December 1, 2014

Study Completion

June 1, 2016

Last Updated

July 19, 2016

Record last verified: 2016-07