An interventional study of Intravascular ultrasound-guided EVT and Angiography-guided EVT in Chronic Limb-Threatening Ischemia, sponsored by Shin Kong Wu Ho-Su Memorial Hospital. Not yet recruiting at 4 sites in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-28.
Sponsored by Shin Kong Wu Ho-Su Memorial Hospital · Not applicable, Interventional, and Treatment
Chronic limb-threatening ischemia (CLTI) is a severe form of peripheral artery disease in which very poor blood flow in the arteries below the knee can cause rest pain, non-healing wounds, and even loss of the limb. It is often treated with endovascular therapy (EVT), a minimally invasive procedure that opens the blocked artery, but the artery frequently narrows or closes again afterward. These procedures are usually guided by X-ray pictures taken with dye (angiography). Intravascular ultrasound (IVUS) is an imaging tool that uses a small catheter inside the artery to give a more detailed view of the vessel, which may help doctors open it more completely. It is not yet clear whether adding IVUS improves results below the knee.
This study is testing whether guiding treatment with IVUS plus angiography keeps the artery open better than angiography alone. Adults aged 18 or older with CLTI who are having endovascular therapy for a blocked artery below the knee may take part. Participants are assigned by chance to be treated with either both imaging methods or angiography alone, and are followed for 12 months. The main question is how well the treated artery stays open at 6 months; researchers will also compare repeat procedures, amputation, complications, wound healing, survival, and quality of life.
356 studies on the registry are indexed under Chronic Limb-Threatening Ischemia; 71 are open to participants now.
This study's planned enrollment of 212 is above the median of 40 across 239 interventional studies indexed under Chronic Limb-Threatening Ischemia.
Browse Chronic Limb-Threatening Ischemia studies →Shin Kong Wu Ho-Su Memorial Hospital is the lead sponsor of 65 studies on the registry; 16 are open to participants now.
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Documented chronic limb-threatening ischemia, meeting the following criteria according to guidelines(13):
Absence of occlusive upstream disease, defined by the following:
:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Intravascular ultrasound-guided EVT
Procedure: Angiography-guided EVT
Endovascular therapy of the below-the-knee artery is guided by intravascular ultrasound (IVUS) imaging in addition to X-ray angiography, with IVUS used to assess the lesion, size and select devices, optimize treatment, and confirm the final result.
Endovascular therapy of the below-the-knee artery is guided by X-ray angiography with contrast dye alone, without the use of intravascular ultrasound, to assess the lesion, size and select devices, and judge the final result.
Primary patency at 6 months
Freedom from clinically driven target lesion revascularization (CD-TLR), total occlusion of the target vessel, or binary restenosis of the target lesion. Binary restenosis is defined as a peak systolic velocity ratio \>2.0 on duplex ultrasound. Reported as the proportion of participants meeting all three criteria.
Time frame: 6 months after the index procedure
Major amputation of the study limb
Proportion of participants undergoing major (above-the-ankle) amputation of the study limb.
Time frame: 12 months
Major adverse limb events (MALE)
Proportion of participants with a major adverse limb event, defined as a composite of above-ankle amputation of the study limb, CD-TLR, or all-cause mortality.
Time frame: 12 months
Composite freedom from limb events
Proportion of participants free from all of the following: major amputation of the study limb, total occlusion of the target vessel, CD-TLR, and binary restenosis of the target lesion (peak systolic velocity ratio \>2.0 on duplex ultrasound).
Time frame: 12 months
Wound healing (Rutherford class 5 participants)
Wound healing rate, reported as the proportion of Rutherford class 5 participants with complete healing of the index wound.
Time frame: 1, 3, 6, 9, and 12 months
Time to complete wound healing (Rutherford class 5 participants)
Time to complete wound healing, reported as the time since the index procedure to complete healing of the index wound in Rutherford class 5 participants.
Time frame: From the index procedure to 12 months
Major adverse cardiovascular events (MACE)
Proportion of participants with a major adverse cardiovascular event, defined as a composite of non-fatal myocardial infarction, non-fatal stroke, or cardiovascular death, and each component reported individually.
Time frame: 12 months
Acute limb ischemia
Proportion of participants with an acute limb ischemia event in the study limb.
Time frame: 12 months
Limb-related mortality
Proportion of participants who die from a limb-related cause.
Time frame: 12 months
All-cause mortality
Proportion of participants who die from any cause.
Time frame: 12 months
Periprocedural complications
Proportion of participants with any periprocedural complication (e.g., dissection, perforation, distal embolization, access-site complication, or contrast-related event) related to the index procedure.
Time frame: During the index procedure through 30 days
Disagreement in imaging findings between angiography and IVUS
Proportion of treated lesions in which intravascular ultrasound (IVUS) findings differ from angiographic findings, as assessed by the core laboratory (including differences in vessel diameter, lesion length, degree of stenosis, plaque or calcium characterization, or identification of dissection or under-expansion).
Time frame: During the index procedure (Day 0)
Procedural success
Proportion of participants achieving procedural success, defined as successful revascularization of the target lesion with residual stenosis below the pre-specified threshold and no major periprocedural complication.
Time frame: During the index procedure (Day 0)
Procedure time
Total time of the index endovascular procedure, in minutes.
Time frame: During the index procedure (Day 0)
Contrast use
Total volume of iodinated contrast used during the index procedure, in milliliters.
Time frame: During the index procedure (Day 0)
Change in quality of life
Change from baseline in health-related quality of life, measured with one generic and two disease-specific instruments: 1. EQ-5D-5L (EuroQol 5-Dimension 5-Level): the descriptive system yields an index value ranging from less than 0 to 1 (1 = full health; higher scores = better quality of life), accompanied by the EQ Visual Analogue Scale scored 0 to 100 (higher = better health). 2. VascuQoL-6 (Vascular Quality of Life Questionnaire, 6-item): total score ranges from 6 to 24 (higher scores = better quality of life). 3. WIQ (Walking Impairment Questionnaire): score ranges from 0 to 100 (higher scores = better, i.e., less walking impairment).
Time frame: Baseline, 1, 3, 6 and 12 months
Change in ankle-brachial index
Change from baseline in ankle-brachial index (ABI)
Time frame: Baseline, 1, 3, 6, 9 and 12 months
Change in toe-brachial index
Change from baseline in toe-brachial index (TBI)
Time frame: Baseline, 1, 3, 6, 9 and 12 months
Change in transcutaneous oxygen pressure
Change from baseline in transcutaneous oxygen pressure (TcPO2)
Time frame: Baseline, 1, 3, 6, 9 and 12 months
Plan to share: No
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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Chronic Limb-Threatening Ischemia →
Shin Kong Wu Ho-Su Memorial Hospital