Critical Limb Ischemia (CLI)VITAL-IT 1NCT07006467
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
A study testing Implantation of RFS in people with Critical Limb Ischemia (CLI), run by Stentit at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Limb Ischemia (CLI)
- What is being tested?
- Implantation of RFS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteAustria
- Study dates
- 3 Jun 2025to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- General inclusion criteria:
- 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.
- Anatomical inclusion criteria:
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- 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
Who cannot join
- General exclusion criteria:
- 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.
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- 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.
- Subject has previously had or requires surgical revascularization involving any vessel of the ipsilateral extremity.
- Subject has signs or symptoms of advanced limb infection or septicemia (fever > 38.5 degrees Celsius, WBC > 15,000 cells/microliter, hypotension) at the time of assessment.
- Subject with extensive tissue loss salvageable only with complex foot reconstruction or non-traditional transmetatarsal amputation.
- Anatomic exclusion criteria:
- Subject has tandem lesions at the target lesion site (plaque free zone < 2 cm)
- Pre-dilatation of the target lesion at the time of study intervention did not reach <50% residual diameter stenosis by angiography.
- Target lesion that has prior metallic stent implant.
- Failed PTA of target lesion ≤ 60 days prior to the procedure date.
- The target vessel has another significant lesion (≥50% diameter stenosis by angiography).
- Significant stenosis (≥50% stenosis) lesion in a distal outflow artery that would be perfused by the target vessel and that requires treatment at the time of the index procedure.
- Subject has angiographic evidence of, thrombus, thromboembolism or atheroembolism in the ipsilateral extremity.
- Unsuccessfully treated proximal inflow limiting arterial stenosis or inflow-limiting arterial lesions left untreated.
- Aneurysm in the iliac, common femoral, superficial femoral, popliteal or target artery of the ipsilateral extremity.
- Target lesion has a high probability that atherectomy will be required at the time of index procedure for treatment of the target vessel.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Medical Universiteit Graz
Graz, A-8036
Tanja Pflanzl, +43 316 385 12911, tanja.pflanzl@medunigraz.at
Marianne Brodmann, MD, Prof
About this study
Official title: Study to Evaluate the Feasibility of the Resorbable Fibrillated Scaffold (RFS) in Arterial Lesions Below the Knee, in Patients With Critical Limb Ischemia
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)
- Being tested
- Implantation of RFS
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of RFSDevice
Percutaneous transluminal implantation of the RFS in the infrapopliteal lesion
| Study group | Role | What they receive |
|---|---|---|
| RFS arm | Experimental | Peripheral transluminal angioplasty with the RFS of the below the knee vasculature Receives: Device: Implantation of RFS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start3 Jun 2025
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Limb Ischemia (CLI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stentit
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07006467
- Sponsor's protocol ID
- CT-10001 VITAL-IT 1
- Acronym
- VITAL-IT 1
- Status last verified
- Jul 2025
- First submitted
- 27 May 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate the Feasibility of the Resorbable Fibrillated Scaffold (RFS) in Arterial Lesions Below the Knee, in Patients With Critical Limb Ischemia
- ClinicalTrials.gov ID
- NCT07006467
- Acronym / sponsor ID
- VITAL-IT 1 / CT-10001 VITAL-IT 1
- Conditions
- Critical Limb Ischemia (CLI)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- StentitIndustry (pharma, biotech, devices)
- Study start
- 3 Jun 2025 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 5 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RFS arm | Experimental | Device: Implantation of RFSPeripheral transluminal angioplasty with the RFS of the below the knee vasculature |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- General inclusion criteria:
Key exclusion criteria (30 listed)
- General exclusion criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantation of RFSPercutaneous transluminal implantation of the RFS in the infrapopliteal lesion | Device | RFS arm |
Primary outcome
Safety: Freedom from Major Adverse Limb Event (MALE) + Perioperative Death (POD)
Time frame: 30 day follow-up
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
Performance: Number of patients with Technical Success
Time frame: perioperative
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantation of RFS in people with Critical Limb Ischemia (CLI), run by Stentit at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kim van Noort, PhD (+3125281513, k.vannoort@stentit.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Freedom from Major Adverse Limb Event (MALE) + Perioperative Death (POD) (time frame: 30 day follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.