Thermovision-controlled Lumbar Sympathetic Blockade in Chronic Limb-threatening Ischemia Treatment (Tevi-LuSy)

E

Europainclinics z.ú.

Status

Enrolling

Conditions

Chronic Limb-Threatening Ischemia

Treatments

Procedure: lumbar sympathetic blockade

Study type

Interventional

Funder types

Other

Identifiers

NCT06111599
4/2023/VUSCH/EK

Details and patient eligibility

About

Thermovision-controlled lumbar sympathetic blockade in chronic limb-threatening ischemia treatment

Full description

Chronic limb-threatening ischemia (CLTI), the end-stage of lower extremity artery disease (LEAD), occurs with growing prevalence around the globe and is associated with increased healthcare costs. CLTI is defined by the presence of LEAD in combination with rest pain, gangrene, or lower limb ulceration lasting more than two weeks. Despite unclear results of abdominal surgical lumbar sympathectomy, novel interventional minimally invasive fluoroscopy-guided procedures seem to be promising. A prospective interventional study will be conducted, primarily targeting patients afflicted by critical limb ischemia, with the incorporation of thermal vision control and tissue oxygen monitoring.

Enrollment

60 estimated patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Chronic limb-threatening ischemia-Patients with chronic leg pain for at least 6 months with intensity (VAS >=5)
  • those who (only if a signature was obtainable), or whose legal guardian,fully understood the clinical trial -details and signed the informed consent form

Exclusion criteria

  • Chronic Venous Insufficiency
  • women with positive a pregnancy tests before the trial or who planned to become pregnant within the following 3 years
  • other patients viewed as inappropriate by the staff
  • disagreement with participation in the study

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 3 patient groups

Group A
Experimental group
Description:
Proximal arterial obliteration
Treatment:
Procedure: lumbar sympathetic blockade
Group B
Experimental group
Description:
Distal arterial obliteration
Treatment:
Procedure: lumbar sympathetic blockade
Group C
Experimental group
Description:
Complex arterial obliteration
Treatment:
Procedure: lumbar sympathetic blockade

Trial contacts and locations

1

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Central trial contact

Ladislav Kočan, MD, PhD, FIPP

Data sourced from clinicaltrials.gov

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