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

NCT07006467 | Recruiting

• 1 other identifier: CT-10001 VITAL-IT 1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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 branches may be treated with institutions standard of care prior to treatment of the target lesion. This may include usage of POBA, BMS, DCB, or DES. The target lesion will be predilated with POBA. Device safety will be assessed throughout the clinical investigation, with primary safety endpoints defined as freedom from Major Adverse Limb Events (MALE) at 30 days follow-up. In addition, MALE at 3-, 6-, 12-, and 24- months follow-up, all adverse events, serious adverse events and all device deficiencies will be captured as secondary endpoints. Device performance will be based on technical success of the implantation defined as successful delivery and deployment with a residual area stenosis of ≤50% as determined on final perioperative IVUS. Primary patency at day of discharge, 30-days, 3-, 6-, 12-, and 24- months follow up will be captured as secondary performance endpoint and are based on duplex ultrasound for all timepoints and angiography and IVUS at 6-months follow-up.

Conditions

Critical Limb Ischemia (CLI)

Outcome Measures

Primary Outcomes (2)

• Safety: Freedom from Major Adverse Limb Event (MALE) + Perioperative Death (POD)

  Safety: Freedom from Major Adverse Limb Event (MALE) + Perioperative Death (POD) * MALE includes: * Above ankle amputation in index limb or Any target lesion re-intervention at 30-day follow-up * POD includes: Mortality at 30 days follow-up

  30 day follow-up

• Performance: Number of patients with Technical Success

  Technical success is defined as successful delivery and deployment of the RFS to the target lesion resulting in a final residual area stenosis of ≤50% as assessed on intravascular ultrasound (IVUS). * Successful delivery is defined as reaching the target lesion and successful withdrawal of the delivery catheter. * Successful deployment is determined by the achieved pressure (in atm) on the balloon combined with visual assessment of the balloon inflation on angiography. * ≤50% residual area stenosis is verified by independent Core Lab analysis of perioperative IVUS measurements. If IVUS is not available or insufficient, ≤30% final residual diameter stenosis at perioperative angiography will be used to assess Technical Success.

  perioperative

Study Arms (1)

RFS arm

EXPERIMENTAL

Peripheral transluminal angioplasty with the RFS of the below the knee vasculature

Device: Implantation of RFS

Interventions

Implantation of RFS DEVICE

Percutaneous transluminal implantation of the RFS in the infrapopliteal lesion

RFS arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must provide written informed consent prior to any clinical investigation related procedures.
• Subject is willing and able to comply with the study procedures, and follow-up schedule.
• Subject has Critical Limb Ischemia (CLI), Rutherford Becker Clinical Category 4 or 5
• Subject must be at least 18 years of age.
• Target lesion located in the tibioperoneal trunk, or 2/3 proximal part of the anterior tibial artery, posterior tibial artery or peroneal artery.
• Only one target lesion per subject is included, other lesions can be treated per institution's standard of care.
• At least one infrapopliteal branch without an angiographic significant lesion (≥50% diameter stenosis by angiography).
• Vessel diameter of 3.0 mm to 3.4 mm. Quantitative imaging (IVUS and angiography) will be used to aid accurate sizing of the vessels.
• Target lesion length ≤ 18 mm.
• Target lesion of ≥70% diameter stenosis, per angiographic assessment at the time of the procedure.
• Target lesion is in an area that may be stented without blocking access to subject main branches, i.e ≥2 mm distanced from any bifurcation.
• Successful antegrade crossing of the target lesion

You may not qualify if:

• Subject is currently participating in another clinical investigation that has not yet reached the primary endpoint.
• Pregnant or nursing subjects or with planned pregnancy during the clinical investigation follow-up period.
• Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements.
• Incapacitated individuals, as defined as persons who are mentally ill, mentally handicapped, or individuals without legal authority, are excluded from the study population.
• Subject has known hypersensitivity or contraindication to device material and its degradants (poly (L-lactide), poly (glycolic acid), lactic acid, and glycolic acid) that cannot be adequately pre-medicated. Subject has known contrast sensitivity that cannot be adequately pre-medicated.
• Subject has known allergy hypersensitivity or contraindication to aspirin; or to ADP antagonists such clopidogrel, prasugrel or ticagrelor; or to anticoagulants such as heparin or bivalirudin, and therefore cannot be adequately treated with study medications.
• Subject with planned surgery or procedure necessitating discontinuation of antiplatelet medications, within 3 months after index procedure.
• Subject has life expectancy ≤ 1 year.
• Subject has had a stroke within the previous 3 months with residual Rankin score of ≥2.
• Subject has renal insufficiency as defined as an estimated GFR \< 30ml/min per 1.73m2
• Subject has platelet count \< 100,000 cells/mm3 or \> 700,000 cells/mm3, a WBC \< 3,000 cells/mm3, or hemoglobin \< 9.0 g/dl.
• Subject has known serious immunosuppressive disease (e.g. human immunodeficiency virus), or has severe autoimmune disease, that requires chronic immunosuppressive therapy (e.g. systemic lupus erythematosus, etc.), or subject is receiving immunosuppression therapy for other conditions. Subjects treated for HIV (Human Immunodeficiency Virus) and who have undetectable viral load, such that their immune system is not considered compromised, are eligible.
• Subject has Body Mass Index (BMI) \< 18.
• Subject has a known coagulation disorder with increased risk of arterial thrombosis. Subject with deep vein thrombosis and disorders that increase the risk of deep vein thrombosis can be included in the study.
• Subject who requires thrombolysis as a primary treatment modality or requires other treatment for acute limb ischemia of the target limb.

Sponsors & Collaborators

• Stentit: lead

Study Sites (1)

Medical Universiteit Graz

Graz, A-8036, Austria

RECRUITING

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Central Study Contacts

Kim van Noort, PhD

CONTACT

+3125281513; k.vannoort@stentit.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 5, 2025
• Study Start: June 3, 2025
• Primary Completion: September 30, 2025
• Study Completion (Estimated): August 31, 2027
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

AU (1)