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Can a sound wave camera inside arteries save more legs?

NCT ID NCT07731997

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 212 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Jul 2030

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

Chronic Limb-Threatening Ischemia limb ischemia peripheral arterial disease

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.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Chi Mei Medical Center

    Tainan, 710, Taiwan

  • Linkou Chang Gung Memorial Hospital

    Taoyuan, 333, Taiwan

  • National Taiwan University Hospital

    Taipei, 100, Taiwan

  • Shin Kong Wu Ho-Su Memorial Hospital

    Taipei, 111, Taiwan

More trials for these conditions

Other studies related to the condition(s) this trial covers.