Chronic Limb-Threatening IschemiaNCT06879561
Pressure Wire Guidance for Infrapopliteal Artery Interventions
A study testing Angiography-guided angioplasty and Pressure wire-guided angioplasty in people with Chronic Limb-Threatening Ischemia, run by Yonsei University at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic Limb-Threatening Ischemia
- What is being tested?
- Angiography-guided angioplasty and Pressure wire-guided angioplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Oct 2025to 29 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with chronic limb threatening ischemia (Rutherford 5)
- Anterior tibial artery or posterior tibial artery lesions ≥ 10 cm Age ≥19 years
Who cannot join
- Acute limb ischemia
- Contraindication to antiplatelet or anticoagulation agents:
- 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
- Life expectancy < 1 year
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Division of Cardiology, Severance Cardiovascular hospital Department of Internal Medicine, Yonsei University College of Medicine
Seoul
young Guk ko, MD, 82-02-2228-8451, ygkp@yuhs.ac
About this study
Official title: Impact of Pressure Wire-guidance Versus Angiography-guidance for Infrapopliteal Artery Interventions on Post-procedural Perfusion Status and Wound Healing in Patients With Chronic Limb Threatening Ischemia (PERFECT-CLI)
"• 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."
Read the detailed description
- Prospective, singlecenter, open label, randomized controlled study
- 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.
- 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.
- The primary efficacy endpoint is attainment of skin perfusion pressure ≥50 mmHg within 1-3 days after the procedure.
- Clinical follow-up will occur at 1, 3, and 6 months to assess wound healing and clinical events.
- Conditions
- Chronic Limb-Threatening Ischemia
- Being tested
- Angiography-guided angioplasty, Pressure wire-guided angioplasty
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angiography-guided angioplastyProcedure or surgery
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.
Pressure wire-guided angioplastyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Angiography-guided angioplasty | Active comparator | In this group, 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. Receives: Procedure: Angiography-guided angioplasty |
| Pressure wire-guided angioplasty | Experimental | In this gorup, 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. Receives: Procedure: Pressure wire-guided angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attainment rate of postprocedural skin perfusion pressure ≥50 mmHg
within 3 days after the index endovascular therapy
Measured: Attainment rate of postprocedural skin perfusion pressure≥50 mmHg within 3 days after the indez endovascular therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start2 Oct 2025
- Primary completion29 Dec 2027 (estimated)
- Study completion29 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Limb-Threatening IschemiaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06879561
- Sponsor's protocol ID
- 1-2024-0068
- Status last verified
- Nov 2025
- First submitted
- 11 Mar 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pressure Wire-guidance Versus Angiography-guidance for Infrapopliteal Artery Interventions on Post-procedural Perfusion Status and Wound Healing in Patients With Chronic Limb Threatening Ischemia (PERFECT-CLI)
- ClinicalTrials.gov ID
- NCT06879561
- Acronym / sponsor ID
- 1-2024-0068
- Conditions
- Chronic Limb-Threatening Ischemia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 2 Oct 2025 (actual)
- Primary completion
- 29 Dec 2027 (estimated)
- Study completion
- 29 Aug 2028 (estimated)
- First posted
- 17 Mar 2025 (actual)
- 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.
"• 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
- Prospective, singlecenter, open label, randomized controlled study
- 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.
- 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.
- The primary efficacy endpoint is attainment of skin perfusion pressure ≥50 mmHg within 1-3 days after the procedure.
- Clinical follow-up will occur at 1, 3, and 6 months to assess wound healing and clinical events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Angiography-guided angioplasty | Active comparator | Procedure: Angiography-guided angioplastyIn this group, 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. |
| Pressure wire-guided angioplasty | Experimental | Procedure: Pressure wire-guided angioplastyIn this gorup, 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient with chronic limb threatening ischemia (Rutherford 5)
- Anterior tibial artery or posterior tibial artery lesions ≥ 10 cm Age ≥19 years
Key exclusion criteria (6 listed)
- Acute limb ischemia
- Contraindication to antiplatelet or anticoagulation agents:
- Pregnant women or women with potential childbearing
- Life expectancy < 1 year
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 |
|---|---|---|
| Angiography-guided angioplastyBalloon 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. | Procedure or surgery | Angiography-guided angioplasty |
| Pressure wire-guided angioplastyBalloon 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. | Procedure or surgery | Pressure wire-guided angioplasty |
Primary outcome
Attainment rate of postprocedural skin perfusion pressure ≥50 mmHg
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Angiography-guided angioplasty and Pressure wire-guided angioplasty in people with Chronic Limb-Threatening Ischemia, run by Yonsei University at 1 site in South Korea.
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 2 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Young-Guk Ko, MD. Division of Cardiology (+82-2-228-8451, ygko@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attainment rate of postprocedural skin perfusion pressure ≥50 mmHg (time frame: Attainment rate of postprocedural skin perfusion pressure≥50 mmHg within 3 days after the indez endovascular therapy). 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 2 Dec 2025.