Acute Ischemia of Lower LimbNCT02835027
Treatment of Acute Lower Limb Ischaemia in Sweden 1994-2014
An observational study of Acute Ischemia of Lower Limb, run by Uppsala University Hospital.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Ischemia of Lower Limb
- What is being tested?
- Open versus endovascular surgery
- Type of treatment
- Surgery or procedure
- How many people
- 16,287 participants
- Where
- No sites listed yet
- Study dates
- Jan 1994to Jun 2016
- How long will I take part?
- 22 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The entire Swedish population, thus no sampling.
Who may be able to join
- 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
Who cannot join
- Acute limb ischemia secondary to trauma, bleedings, dissection or graft infections.
- Suprainguinal occlusions.
About this study
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.
Read the 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.
- Conditions
- Acute Ischemia of Lower Limb
- Being tested
- Open versus endovascular surgery
- Keywords
- Acute limb ischaemia(ALI), Acute ischaemia of the lower extremity, Thrombosis, Emboli, Endovascular surgery, Surgery, Amputation free survival, Long time survival, Demographics
- Medical subject headings
- Thrombosis, Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open versus endovascular surgeryProcedure or surgery
Treatment for acute ischemia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-22 years
Secondary outcomes (3)
Amputation
Major amputation is defined as amputation above foot-level. Either the leg is amputated or not.
Measured: 1-22 years
Survival
Either the patient is dead or alive
Measured: 1-22 years
Complications 30 days after surgery
Bleeding, myocardial infarction, stroke, occlusion, compartment syndrome, etc
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2016 (estimated)
- Study startJan 1994
- Primary completionDec 2014
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemia of Lower LimbStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16,287 participants (actual)
- Target duration
- 22 Years
Sponsor and investigators
- Lead sponsor
- Uppsala University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Bjorck, Uppsala University Hospital
- Investigators
- Martin Björck, Professor, Study director, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02835027
- Sponsor's protocol ID
- Dnr2014/325
- Status last verified
- Jul 2016
- First submitted
- 13 Jul 2016
- Last updated
- 19 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Acute Lower Limb Ischaemia in Sweden 1994-2014
- ClinicalTrials.gov ID
- NCT02835027
- Acronym / sponsor ID
- Dnr2014/325
- Conditions
- Acute Ischemia of Lower Limb
- Keywords
- Acute limb ischaemia(ALI), Acute ischaemia of the lower extremity, Thrombosis, Emboli, Endovascular surgery, Surgery, Amputation free survival, Long time survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16,287 participants (actual)
- Lead sponsor
- Uppsala University HospitalUniversity, hospital or other
- Study start
- Jan 1994
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 15 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 22 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The entire Swedish population, thus no sampling.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Acute limb ischemia secondary to trauma, bleedings, dissection or graft infections.
- Suprainguinal occlusions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open versus endovascular surgeryTreatment for acute ischemia | Procedure or surgery | – |
Primary outcome
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.
3 secondary outcomes
Amputation
Time frame: 1-22 years
Survival
Time frame: 1-22 years
Complications 30 days after surgery
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Ischemia of Lower Limb
RecruitingObservational study
A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System (STRIDE II)
Lower Extremity Acute Limb Ischemia, LE ALI
Active, not recruiting
Physician Clinical Trial Policy (CTP) Neurological Ischemia Lower Extremity Pain and Swelling
Lower Extremity Swelling Acute
RecruitingObservational study
Prognosis and Diagnosis of Spasticity in Acute-post Stroke Patients
Stroke, Acute, Stroke, Ischemic
Not yet recruitingObservational study
Ischemia Detection During Development of Acute Compartment Syndrome
Ischemia Limb, Blood Circulation Disorder
Active, not recruitingObservational study
Evaluation of Platelet Aggregability in Patients With Previous Acute Myocardial Infarction or Concomitant Lower Extremity Peripheral Artery Disease
Coronary Artery Disease, Peripheral Arterial Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Björck, Professor study director
Uppsala University
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemia of Lower Limb, run by Uppsala University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amputation-free survival (time frame: 1-22 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2016.