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Which artery plug works best? trial pits proglide against femoseal

NCT ID NCT03192033

Disease control Sponsor: Nantes University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

People with peripheral arterial disease often need minimally invasive procedures that thread catheters through the femoral artery in the groin. Afterward, doctors use closure devices to stop bleeding at the puncture site. This trial randomly assigns participants to one of two devices, Proglide or Femoseal, and compares how well each seals the artery without major complications. Researchers also track walking recovery time and any artery-related problems.

What this could mean

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

Active substance
Arterial closure devices: Proglide and Femoseal
What this could lead to
If one device seals the artery more reliably, doctors could choose it to help patients walk sooner and avoid complications after leg artery procedures.
What could go wrong
This is a comparison of two existing devices, not a new treatment. Both are already used, and any difference between them may be small or limited to certain 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.

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

233 people

The number who actually took part.

Started

Dec 2017

Finished

Jun 2019

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: * Age \> 18 years, * Patient with peripheral arterial disease * Endovascular examination or treatment compatible with a 5F to 7F sheath * Walking ability * Patient affiliated with a social security scheme * Patient's signed informed consent form Exclusion Criteria: * Under-age patient * Patient of age, but under legal guardianship or care * Contraindication to endovascular treatment * Use of a 8F or greater sheath * Morbidity contraindicating same-day walking * History of ipsilateral open common femoral artery surgery * Stent at the puncture site * Radial or brachial puncture * Antegrade femoral puncture * Acute ischemia * Life expectancy of less than one month * Patient refusal to take part in the study * Participation in another therapeutic trial * Pregnant woman * Allergy to clopidogrel or aspirin

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Conditions

The condition(s) this trial relates to.

peripheral arterial disease

As listed by the trial registrant

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

Peripheral arterial disease

Contacts and locations

Locations

  • CH de Cholet

    Cholet, France

  • CHD La Roche-sur-Yon

    La Roche-sur-Yon, France

  • CHU Angers

    Angers, France

  • CHU Brest

    Brest, France

  • CHU de Poitiers

    Poitiers, France

  • CHU de Rennes

    Rennes, France

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