Esprit BTK Post-Approval Study (PAS)

Clinical Trial Details

The purpose of this research is to assess the continued safety and efficacy of the Esprit BTK system, which was recently approved by the U.S. Food and Drug Administration (FDA) for the treatment of narrowed arteries below the knee in patients with Chronic Limb-Threatening Ischemia (CLTI).

Participants may enroll in the study if this stent is used during their procedure.

Study participation will last for three years, with follow-up visits (after the procedure) at 30 days, 90 days, 180 days, 1 year, 2 years, and 3 years.

Key Eligibility:

Open to men and women above the age of 18 with arterial narrowing in infrapopliteal lesions causing chronic limb-threatening ischemia.
Participants must not have been previously treated with Esprit BTK Scaffold or any other metallic stent in target limb

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Study contact by location

Upper East Side - Manhattan

Contact(s)

Rosa Aurora Chu
roc2025@med.cornell.edu

Primary Investigator(s)

Brian DeRubertis, MD

Protocol ID(s)

Weill Cornell Medicine IRB #:

2407027761

ClinicalTrials.gov:

NCT06656364

Status

Open to Enrollment

Age Group

Adult

Disease

Chronic Limb-Threatening Ischemia

Surgery