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New imaging tool may help doctors place stents more precisely in leg arteries

NCT ID NCT05057637

Knowledge-focused Sponsor: Rijnstate Hospital 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether using a high-detail imaging tool called optical coherence tomography (OCT) helps doctors make better decisions when placing stents to open blocked leg arteries. About 25 adults with leg artery narrowing will be enrolled. Doctors will first plan treatment using standard X-ray images, then use OCT to see if they change their plan. The goal is to see how often OCT leads to different stent size or position choices, which could improve long-term results.

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 25 people

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

Started

Mar 2022

Expected to finish

Apr 2027

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

Patients diagnosed with one or more stenotic lesions in the femoropopliteal tract that are scheduled for endovascular treatment with a Supera interwoven nitonol stent or Absolute nitinol stent.

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: * Aged 18 years of older * Written informed consent * Scheduled endovascular treatment of femoropopliteal stenotic lesions with a Supera interwoven nitinol stent or Absolute nitinol stent * Clinically and hemodynamically stable Exclusion Criteria: * Occluded superficial femoral artery or popliteal artery * Superficial femoral artery and/or popliteal artery diameter larger than 6.5 mm * Severely impaired renal function (eGFR \< 30 ml/min), end stage renal disease * Cardiac insufficiency (NYHA 3-4) * Hypersensitivity to iodinated contrast media * BMI \> 25 and contralateral approach not possible * Minimal lumen diameter of target lesion \< 1.5 mm * Presence of a hemodynamically significant inflow stenosis in the aorto-iliac tract or the common femoral artery * Participating in another trial with an investigational drug or medical device concerning the femoropopliteal tract interfering with the current study * Life expectancy of less than 24 months * Women of child-bearing age not on active birth control * Legally incapable

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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.

Femoropopliteal stenosis

Contacts and locations

Locations

  • Rijnstate

    Arnhem, Gelderland, 6815 AD, Netherlands

More trials for these conditions

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