Dissolvable scaffold for leg arteries under Real-World watch

NCT ID NCT06656364

Ongoing Disease control Sponsor: Abbott Medical Devices Source: ClinicalTrials.gov ↗

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.

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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

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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

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