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Dissolvable scaffolds could save legs from amputation in major new trial

NCT ID NCT07270575

Disease control Sponsor: Cardiovascular and Interventional Radiological Society of Europe 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jul 08, 2026 · Updated 3 times

Summary

This Europe-wide study will follow 400 people with severe leg artery disease (chronic limb-threatening ischemia) to see if a new dissolvable, drug-coated scaffold can keep leg arteries open better than standard treatments. The scaffold releases medication to prevent re-blockage and then dissolves over time, avoiding the long-term risks of permanent metal stents. Participants must have heavily calcified arteries in the lower leg and be willing to undergo the procedure.

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 400 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

Dec 2032

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

Adult CLTI patients treated with the Esprit BTK everolimus-eluting resorbable scaffold following adequate vessel preparation for infrapopliteal artery disease.

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. Rutherford classification category ≥4; 2. Treatment of infrapopliteal lesions with the Esprit BTK everolimus eluting resorbable scaffold system following adequate vessel preparation; 3. Calcification of target lesions must be visible on fluoroscopy or CT-angiography; 4. Patients competent and willing to provide informed consent. Exclusion Criteria: 1. Minors and other vulnerable populations who may not be able to give informed consent freely or for whom participation is not essential to the study (incapacitated and unconscious individuals, persons deprived of liberty, pregnant and breastfeeding women, etc.); 2. Inadequate inflow (\>30% stenosis) following optimization; 3. Insufficient direct outflow (less than 1 run-off vessel); 4. Endovascular procedure(s) on the treatment site within 4 weeks before index procedure; 5. Patients planned to receive an above ankle amputation of the target limb; 6. Patients enrolled in ORACLE (ClinicalTrials.gov ID NCT07270562).

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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.

Chronic limb-threatening ischemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. 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 ↗

  2. 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.

More trials for these conditions

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