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Super-Resolution ultrasound may spot hidden clues in leg artery disease

NCT ID NCT07374601

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a new ultrasound technique called super-resolution ultrasound microvascular imaging (SRUMI) to see if it can predict how peripheral artery disease (PAD) will progress. Researchers will scan the legs of 300 people with PAD and compare the images to standard tests. The goal is to find a better way to assess risk and guide treatment without using radiation.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SonoVue microbubble contrast agent
What this could lead to
If successful, this could provide a new, noninvasive way to predict disease progression and guide treatment for peripheral artery disease.
What could go wrong
This is an early-stage observational study, not a treatment trial. The new imaging method may not prove more useful than existing tests, and results may not apply to all patients.

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.

Participants

About 300 people

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

Started

Feb 2026

Expected to finish

Dec 2028

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.

Who is studied

\*\*Study Population Description:\*\* Participants will be recruited from the Department of Interventional Vascular Surgery at Peking University First Hospital. The cohort comprises two parallel groups: (i) patients hospitalized with a confirmed diagnosis of PAD, and (ii) control participants without PAD (i.e., non-atherosclerotic controls), matched for age and sex where feasible. Enrollment adheres strictly to the prespecified inclusion and exclusion criteria above. \*\*Sampling Method:\*\* Convenience sampling (a form of non-probability sampling), reflecting real-world clinical recruitment within a single tertiary academic medical center.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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. Adults aged ≥18 years and ≤100 years; 2. Diagnosis of peripheral artery disease (PAD) confirmed by comprehensive clinical assessment-including characteristic symptoms (e.g., intermittent claudication, rest pain), physical findings (e.g., diminished or absent distal pulses, bruits), ankle-brachial index (ABI) \< 0.9, and corroborating vascular imaging (e.g., duplex ultrasonography, CTA, or MRA); 3. Alternatively, healthy adults without PAD (i.e., ABI ≥ 0.9, absence of suggestive symptoms or signs, and no history of atherosclerotic cardiovascular disease) who meet all other eligibility requirements; 4. Willing and able to provide written informed consent. \*Exclusion Criteria:\* 1. Inability to complete study procedures due to: 1. Severe involuntary movement disorders (e.g., advanced Parkinson's disease or cerebellar ataxia) interfering with image acquisition; 2. Contraindication to contrast-enhanced ultrasound (e.g., documented hypersensitivity to sulfur hexafluoride microbubble contrast agent \[SonoVue®\]); 3. Active lower-limb infection (e.g., diabetic foot infection with systemic signs or osteomyelitis), which precludes safe or interpretable data collection; 2. Cognitive impairment or legal incapacity precluding autonomous informed consent; 3. Refusal-by the participant or their legally authorized representative-to provide informed consent.

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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.

  1. The places running it

    1 site. 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

  • Peking University First Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100034, China

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