Treatment of Acute Lower Limb Ischaemia in Sweden 1994-2014

Acute Ischemia of Lower Limb Clinical Trial

Official title:

Treatment of Acute Lower Limb Ischaemia in Sweden 1994-2014

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02835027
• Other study ID #: Dnr2014/325
• Status: Completed
• Phase: N/A
• First received: July 13, 2016
• Last updated: July 18, 2016
• Start date: January 1994
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: Uppsala University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16287
• Est. completion date: June 2016
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Ischemia of Lower Limb
• Ischemia

Intervention

Procedure:
• Open versus endovascular surgery
Treatment for acute ischemia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University Hospital

Outcome

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