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Dissolvable scaffold for leg arteries under Real-World watch

NCT ID NCT06656364

Disease control Sponsor: Abbott Medical Devices 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows about 200 people with chronic limb-threatening ischemia (CLTI) who receive the Esprit BTK System, a dissolvable scaffold coated with a drug to keep leg arteries open. The goal is to see how safe and effective it is in routine medical practice. Researchers will track whether patients need repeat procedures or experience major complications like limb loss or death.

What this could mean

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

Active substance
Esprit BTK System (a dissolvable scaffold coated with everolimus drug)
What this could lead to
If successful, this could confirm that the Esprit BTK scaffold is a safe and effective option to improve blood flow and prevent limb loss in people with severe leg artery disease.
What could go wrong
This is an observational study after approval, not a randomized trial, so results may be less definitive. Risks include possible need for repeat procedures, death, or limb loss.

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

200 people

The number who actually took part.

Started

Oct 2024

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: * General Inclusion Criteria 1. Subject must provide written informed consent prior to any study-specific procedures which are not considered standard of care at the site. 1. Informed consent can be obtained up to 3 days post-procedure or prior to discharge whichever comes first. 2. Subject, or a legally acceptable representative must provide written informed consent per site IRB/EC requirements. 2. Subject must be at least 18 years of age. 3. Subject has evidence of symptomatic Chronic Limb-Threatening Ischemia (CLTI) with infrapopliteal lesions. * Anatomic Inclusion Criteria 1. Subjects who have lesion(s) in an infrapopliteal vessel with reference vessel diameter ≥ 2.5 mm and ≤ 4.0 mm. 2. Target lesion(s) must have ≥ 70% stenosis, per visual assessment at the time of the procedure. If needed, quantitative imaging (angiography and intravascular imaging) can be used to aid accurate sizing of the vessels. Exclusion Criteria: * General Exclusion Criteria 1. Subjects who have contraindications to the Esprit BTK System per the instruction for use (IFU). 2. Subject is currently participating in another clinical investigation that has not yet completed its primary endpoint. 3. Subject or Legally Acceptable Representative (LAR) is unable or unwilling to provide written consent prior to enrollment. 4. Subject with life expectancy ≤ 1 year. 5. Subject with an unsalvageable limb (as per physician assessment at the time of the index procedure), who is likely to get a below-the-knee amputation. * Anatomic Exclusion Criteria 1. Subject has in-stent restenosis in the target vessel or requires a metallic stent as part of a planned treatment or a bailout in the target vessel during the index procedure. 2. Subject had been previously treated with Esprit BTK Scaffold(s) within the past 30 days in the same vessel.

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Conditions

The condition(s) this trial relates to.

Chronic Limb-Threatening Ischemia limb ischemia

As listed by the trial registrant

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

Chronic limb-threatening ischemia

Contacts and locations

Locations

  • Al Qassimi Hospital

    Sharjah city, Emirate of Sharjah, 3500, United Arab Emirates

  • Ansaarie Cardiac and Endovascular Center of Excellence

    Saint Augustine, Florida, 32080, United States

  • Ascension St. John Jane Phillips

    Bartlesville, Oklahoma, 74006, United States

  • Auckland City Hospital

    Auckland, 1003, New Zealand

  • Baylor All Saints Medical Center at Fort Worth

    Fort Worth, Texas, 76104, United States

  • Cardiovascular Consultants of South Georgia, LLC

    Thomasville, Georgia, 31792, United States

  • Carolinas Medical Center

    Charlotte, North Carolina, 28203, United States

  • Charlton Memorial Hospital

    Fall River, Massachusetts, 02720, United States

  • Christ Hospital

    Cincinnati, Ohio, 45255, United States

  • ClinRé 001-100 - Denver

    Denver, Colorado, 80220, United States

  • Erlanger Medical Center

    Chattanooga, Tennessee, 37403, United States

  • First Coast Cardiovascular Institute

    Jacksonville, Florida, 32256, United States

  • Good Samaritan Hospital

    Los Angeles, California, 90017, United States

  • Grady Clinical Research Center

    Atlanta, Georgia, 30303, United States

  • HCA Houston Healthcare Medical Center

    Houston, Texas, 77004, United States

  • Hendrick Medical Center

    Abilene, Texas, 79601, United States

  • Hightower Clinical

    Oklahoma City, Oklahoma, 73102, United States

  • HonorHealth

    Scottsdale, Arizona, 85258, United States

  • Jackson Heart Clinic

    Jackson, Mississippi, 39216, United States

  • Johnson City Medical Center Hospital

    Johnson City, Tennessee, 37604, United States

  • Medical City Arlington

    Arlington, Texas, 76014, United States

  • Mount Sinai Hospital

    New York, New York, 10019, United States

  • NYU Langone Health

    New York, New York, 10016, United States

  • New York Presbyterian Hospital-Cornell University

    New York, New York, 10021, United States

  • New York University Hospital

    New York, New York, 10016, United States

  • New York-Presbyterian/Columbia University Medical Center

    New York, New York, 10032, United States

  • North Mississippi Medical Center

    Tupelo, Mississippi, 38801, United States

  • Oklahoma Heart Hospital

    Oklahoma City, Oklahoma, 73120, United States

  • Pima Heart and Vascular Clinical Research

    Tucson, Arizona, 85718, United States

  • Queen Mary Hospital

    Hong Kong, HK SAR, 999077, Hong Kong

  • SIU School of Medicine

    Springfield, Illinois, 62794, United States

  • Sorin Medical

    New York, New York, 10005, United States

  • St. Francis Hospital

    Roslyn, New York, 11576, United States

  • St. Vincent Hospital

    Indianapolis, Indiana, 46260, United States

  • Staten Island University Hospital - North

    Staten Island, New York, 10305, United States

  • Tallahassee Research Institute

    Tallahassee, Florida, 32308, United States

  • UCSF Fresno

    Fresno, California, 93720, United States

  • University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas, 75390, United States

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010, United States

More trials for these conditions

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