Pressure Wire Guidance for Infrapopliteal Artery Interventions
ConditionChronic Limb-Threatening Ischemia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorYonsei University
About this trial
"• 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."
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient with chronic limb threatening ischemia (Rutherford 5)
Anterior tibial artery or posterior tibial artery lesions ≥ 10 cm Age ≥19 years
Disqualifiers
Acute limb ischemia
Thrombocytopenia (platelet <100,000/uL)
Previous cerebral hemorrhage, GI bleeding, other reasons for increased bleeding risk within 6 months
Pregnant women or women with potential childbearing
Trial design
Design model
Parallel
Treatments tested in this trial
Angiography-guided angioplasty
Procedure/SurgeryBalloon 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.
Pressure wire-guided angioplasty
Procedure/SurgeryBalloon 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Angiography-guided angioplastyActive comparator 1 intervention
Group B: Pressure wire-guided angioplastyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Attainment rate of postprocedural skin perfusion pressure ≥50 mmHg
within 3 days after the index endovascular therapy
Time frame
Attainment rate of postprocedural skin perfusion pressure≥50 mmHg within 3 days after the indez endovascular therapySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov