Initial Feasibility Study of the STENTiT Resorbable Fibrillated Scaffold (RFS). The RFS is Intended to Restore Lumen Patency and Blood Flow to Infrapopliteal Arteries. The RFS is a Fully Electrospun Tubular Device With a Fibrillated Microarchitecture and Designed for Transcatheter Delivery

Recruiting N/A Interventional Study
Critical Limb Ischemia (CLI)
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
10 (estimated)
Sponsor
Stentit · Industry
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About This Trial
This is the First-In-Human feasibility study of the RFS for below the knee lesions in subjects who experience critical limb ischemia due to the peripheral artery disease. The aim of this study is to investigate if the RFS can be implanted safely and with technical success. Up to 10 subjects will be treated with the RFS at one investigational site. Lesions within the inflow trajectory or side branc…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * General inclusion criteria: 1. Subject must provide written informed consent prior to any clinical investigation related procedures. 2. Subject is willing and able to comply with the study procedures, and follow-up schedule. 3. Subject has Critical Limb Ischemia (CLI), …
Contacts

Kim van Noort, PhD

+3125281513

k.vannoort@stentit.com

CONTACT