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Could a simple device make shoulder artery procedures safer?

NCT ID NCT07714824

Disease control Sponsor: Pirogov Russian National Research Medical University Source: ClinicalTrials.gov ↗

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 20, 2026 · Last updated Jul 24, 2026 · Updated 2 times

Summary

This trial tests whether a special compression device called NewMan can reduce bleeding and bruising after a shoulder artery procedure compared to a standard pressure bandage. The study involves 229 adults with blocked leg arteries who need a catheter inserted through the arm. Doctors will check for complications like hematomas or artery blockages within 72 hours after the procedure.

What this could mean

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

Active substance
NewMan compression device
What this could lead to
If effective, this device could reduce bleeding and bruising after shoulder artery procedures, making them safer and lowering the need for emergency surgery.
What could go wrong
This is a single-center study with 229 participants, so results may not apply to all patients. The device may not reduce complications significantly compared to a standard bandage.

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

229 people

The number who actually took part.

Started

Aug 2024

Finished

Jun 2026

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: * arterial diameter at the access site of at least 3 mm * indications for endovascular intervention on the lower extremity arteries * age of 18 years or more, and patient consent to participate in the study Exclusion criteria: * inability to perform an access due to stenotic lesions of the above-mentioned arteries (axillary, subclavian arteries, and brachiocephalic trunk) * height exceeding 180 cm; presence of concomitant pathology that limits patient survival; pathology of the blood coagulation system (hemophilia, thrombocytopathies, etc.) * previous catheterizations performed through the access artery

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Conditions

The condition(s) this trial relates to.

arteriosclerosis obliterans peripheral arterial disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Access complication Atherosclerosis of the arteries of the lower extremities Brachial access Compression device Endovascular treatment of arteriosclerosis obliterans of lower extremities occlusion of the femoral-popliteal segment Hemostasis compression device

Contacts and locations

Locations

  • Central Clinical Hospital of St. Alexy Metropolitan of Moscow of the Moscow Patriarchate of the Russian Orthodox Church, Moscow

    Moscow, 117513, Russia

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