Can a sound wave camera inside arteries save more legs?
NCT ID NCT07731997
First seen Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time
Summary
This study compares two ways to guide a minimally invasive procedure that opens blocked arteries below the knee in people with chronic limb-threatening ischemia, a severe form of peripheral artery disease. One group receives standard X-ray guidance (angiography) alone; the other also gets intravascular ultrasound, which uses a tiny camera on a catheter to give a detailed inside view of the artery. The main question is whether adding ultrasound helps keep the artery open longer and reduces the need for repeat procedures or amputation.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Intravascular ultrasound (IVUS) imaging added to standard X-ray angiography during endovascular therapy
- What this could lead to
- If IVUS proves better, it could become the new standard for guiding leg-artery procedures, potentially reducing repeat blockages and amputations.
- What could go wrong
- This is a single-center trial with 212 participants, so results may not apply broadly. IVUS adds cost and procedure time, and it is not yet clear whether the extra detail translates into better outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 212 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥18 years. 2. Documented chronic limb-threatening ischemia, meeting the following criteria according to guidelines(13): * Presence of ischemic symptoms compatible with CLTI, defined as arterial insufficiency with gangrene, non-healing ischemic ulcer, or rest pain consistent with Rutherford classes 4-5 AND * Imaging evidence within the past 12 months showing atherosclerotic PAD, including CTA, MRA, angiography or duplex ultrasound AND * Ankle-Brachial Index (ABI) ≤0.80 or Toe-Brachial Index (TBI) ≤0.60 for patients who never underwent revascularization; ABI ≤0.85 or TBI ≤0.65 for those with history of prior revascularization procedures OR * Ischemic rest pain alone (Rutherford class 4) with ankle systolic pressure \<50 mmHg, toe pressure of \<30 mmHg, transcutaneous PO2 of \<30 mmHg, or flat-line transtarsal pulse volume recording OR * Tissue loss with or without ischemic rest pain (Rutherford class 5) with ankle systolic pressure \<70 mmHg, toe pressure of \<50 mmHg, transcutaneous PO2 of \<30 mmHg, or flatline transtarsal pulse volume recording 3. Absence of occlusive upstream disease, defined by the following: * Demonstrated vascular patency from the aorta to the second segment of the popliteal artery (P2), either by angiography, duplex ultrasound, CTA or MRA within the last 7 days prior to randomization * In patients who underwent prior treatment for upstream disease, there are no restrictions in treatment modalities received as long as patency is demonstrated as previously defined * If upstream disease is planned to be treated in the same index procedure, technically successful treatment of the upstream vessels must be achieved before randomization, defined as less than 30% residual stenosis and no flow-limiting dissections 4. Informed Consent: * Demonstrated ability and willingness to adhere to the study protocol and provide written informed consent Exclusion Criteria: 1. Age \<18 years 2. Asymptomatic or mild disease: patients who underwent revascularization for disease graded Rutherford classes 0-3 3. Patients with major tissue loss (Rutherford 6) in whom major amputation was planned at the time of screening 4. Patient with a history of prior major (above-the-ankle) amputation of the study limb 5. Unable to tolerate any antiplatelet agent or with severe bleeding diathesis 6. Clinical signs of active, uncontrolled, severe limb infection or septicemia, defined as fever exceeding 38.5°C, a white blood cell count above 15,000 cells/µL, or hypotension, at the time of screening (this does not include osteomyelitis confined to the phalanges or metatarsal heads or foot cellulitis treatable with IV antibiotics at the time of revascularization) 7. Acute coronary syndrome or acute stroke within 30 days of screening 8. Active hepatitis or severe liver cirrhosis (Child Pugh C) 9. Advanced CKD (defined with eGFR\<30 mL/min/1.73m2) or end-stage renal disease 10. Pregnancy, breastfeeding, or women of childbearing potential who are not using an effective method of contraception 11. Previous (within 30 days) or concomitant participation in another clinical study with investigational medicinal product(s) that has not yet reached its primary endpoint 12. Life expectancy \<1 year
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Chi Mei Medical Center
Tainan, 710, Taiwan
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Linkou Chang Gung Memorial Hospital
Taoyuan, 333, Taiwan
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National Taiwan University Hospital
Taipei, 100, Taiwan
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Shin Kong Wu Ho-Su Memorial Hospital
Taipei, 111, Taiwan
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Other studies related to the condition(s) this trial covers.
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