Chronic Limb-Threatening Ischemia
Conditions
Brief summary
• A prospective, single-center randomized controlled comparison trial. * A total of 100 patients with symptoms of chronic limb-threatening ischemia (Rutherford category 5) undergoing endovascular treatment for anterior tibial artery or posterior tibial artery lesions will be included if they meet the inclusion criteria and do not meet any exclusion criteria. * Patients will be randomized in a 1:1 open-label manner either to the pressure wire-guided group or the angiography-guided group. * Patients will be treated with balloon angioplasty for anetrior tibial artery or posterior tibial artery lesions. * In the angiography-guided group, balloon angioplasty will be performed to achieve an optimal procedural result, as determined by angiography. Optimal results are defined as antegrade blood flow without residual stenosis \>50% or flow-limiting dissection. * In the Pressure Wire-guided gorup, balloon angioplasty will be performed to obtain optimal procedural result based on both angiography and a pressure gradient over the target lesion. Optimal pressure gradient is less than 10 mmHg by measurement using a Pressure Wire. * The primary efficacy endpoint is defined by attaiment of skin perfusion pressure ≥50 mmHg within 1-3 days after the index procedure. * Patients will be followed at 1, 3, and 6 months after the procdure to assess wound healing status, and clinical events.
Detailed description
1. Prospective, singlecenter, open label, randomized controlled study 2. Eligible patients with chronic limb-threatening ischemia (Rutherford category 5) undergoing endovascular treatment for anterior tibial artery or posterior tibial artery lesions will be randomized to pressure wire-guided or angiography-guided groups. 3. All patients will undergo balloon angioplasty for anterior or posterior tibial artery lesions, with the angiography-guided group aiming for optimal procedural results based on angiography, and the pressure wire-guided group aiming for optimal results based on both angiography and pressure gradient measurements. 4. The primary efficacy endpoint is attainment of skin perfusion pressure ≥50 mmHg within 1-3 days after the procedure. 5. Clinical follow-up will occur at 1, 3, and 6 months to assess wound healing and clinical events.
Interventions
PROCEDUREAngiography-guided angioplasty
Balloon angioplasty will be performed on the target infrapopliteal artery lesion to achieve an optimal procedural result, as determined by angiography. Optimal results are defined as antegrade blood flow without residual stenosis \>50% or any flow-limiting dissection.
PROCEDUREPressure wire-guided angioplasty
Balloon angioplasty will be performed on the target infrapopliteal artery lesions to achieve an optimal procedural result, as determined by the pressure gradient across the target lesion. An optimal procedural result is defined as pressure gradient less than 10 mmHg, measured using a Pressure Wire.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient with chronic limb threatening ischemia (Rutherford 5) * Anterior tibial artery or posterior tibial artery lesions ≥ 10 cm Age ≥19 years
Exclusion criteria
* Acute limb ischemia * Contraindication to antiplatelet or anticoagulation agents: 1. Thrombocytopenia (platelet \<100,000/uL) 2. Previous cerebral hemorrhage, GI bleeding, other reasons for increased bleeding risk within 6 months * Pregnant women or women with potential childbearing * Life expectancy \< 1 year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Attainment rate of postprocedural skin perfusion pressure ≥50 mmHg | Attainment rate of postprocedural skin perfusion pressure≥50 mmHg within 3 days after the indez endovascular therapy | within 3 days after the index endovascular therapy |
Countries
South Korea
Contacts
Primary ContactYoung-Guk Ko, MD. Division of Cardiology
Outcome results
None listed