Chronic Total Occlusion of Artery of the ExtremitiesNCT06492733
FastWire REvascularisation of Extremities, (For LOWer Limbs) - FREEFLOW
A study testing FastWire System - Peripheral in people with Chronic Total Occlusion of Artery of the Extremities, run by Versono Medical Ltd at 6 sites in United States.
Trial summary
This study is to assess the safety and efficacy of the FastWire System. It is intended to assess that the FastWire System can facilitate the intra-luminal placement of conventional guidewires or treatment devices beyond peripheral artery chronic total occlusions (CTOs) Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Total Occlusion of Artery of the Extremities
- What is being tested?
- FastWire System - Peripheral
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 6 sitesUnited States
- Study dates
- 5 Nov 2024to Nov 2026
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Subjects who meet any of the following criteria are not eligible for this clinical investigation:
- Life expectancy of less than 12 months.
- Females who are pregnant or lactating (urine test for women of childbearing age).
- Myocardial infarction or stroke in two months prior to the index procedure.
- Known, unstable coronary artery disease or other, uncontrolled comorbidity.
- Any known haemorrhagic or coagulation deficiency.
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- Known sensitivity to nickel, titanium, or their alloys.
- Evidence of active infection, including but not limited to the target limb.
- Current use of cocaine or other substances of abuse.
- Patients who have received any thrombolytic therapy in the last two weeks.
- History of severe allergy or contraindication, to contrast medium or other medications used during or after endovascular therapy.
- Subject participating in another study involving an investigational drug or device.
- Patient has surgery or vascular intervention planned within 30 days of the index procedure.
- Patient has had a previous peripheral bypass that includes the target vessel.
- Patient has had a previous intervention in the target CTO (angioplasty, stenting) including previous attempt at time of index procedure.
- Patient tests positive for coronavirus disease (COVID-2019), as per site standard practice.
- Estimated Glomerular Filtration Rate (eGFR) of less than 30 ml/min or creatine level >2.5mg/ml.
- Platelet count < 50,000/μL.
- Angiographic Exclusion Criteria
- Unless otherwise specified, the Investigator performing the procedure bases angiographic exclusion on a visual determination of qualification imaging taken at the time of the procedure. Subject is excluded if ANY of the following angiographic exclusion criteria is met:
- For below-the-knee CTOs, a target limb without at least one patent (<50% stenosis) run-off vessel confirmed by angiography or magnetic resonance angiography at the time of the procedure.
- Has an acute or sub-acute intraluminal thrombus within the target vessel.
- Aneurysm distal to puncture access site at least twice the reference vessel diameter, located in the index vessel, abdominal aorta, iliac, or popliteal.
- Has perforation, dissection, or other injury of the access site or index vessel requiring stenting or surgical intervention prior to attempting crossing of the target lesion with the FastWire System.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Vascular Institute of Chattanooga
Chattanooga, Tennessee, 37421
Lacey Weeks, 423-602-2750, lweeks@vascularinstituteofchattanooga.com
Dr. Christopher LeSar, M.D.
- Recruiting
Vascular & Embolization Specialists
Cocoa, Florida, 32926
Brandon Galaviz, 210-990-5556, bgalaviz@orcaresearchgroup.com
Dr Derek Mittleider, MD
- Recruiting
Vascular Institute of the Midwest
Davenport, Iowa, 52807
Dr. Eric Dippel, M.D., 563-324-3818, dippel@vimidwest.com
Dr. Eric Dippel, M.D.
- Recruiting
Dearborn Cardiology
Dearborn, Michigan, 48126
Sam Rengade, 313-887-4011, Samruddhi.Rengade@amr-clinical.com
Dr Fadi Saab, MD
- Recruiting
Cardiovascular Institute of the South-ASC
Gray, Louisiana, 70359
Darla Patrick, RN, CCRC, 985-873-5684, Darla.partick@cardio.com
Dr. Craig Walker, M.D.
- Recruiting
EndoVascular Consultants
Wilmington, Delaware, 19805
Jas Kaur, 347-944-4694, jkaur@orcaresearchgroup.com
Dr. Mark Garcia, MD
About this study
Official title: A Pivotal, Single-arm, Multi-centre, Prospective Clinical Investigation to Assess the Efficacy and Safety of the FastWire REvascularisation of Extremities, (For LOWer Limbs) (FREEFLOW).
This study is to assess the safety and efficacy of the FastWire System. It is intended to assess that the FastWire System can facilitate the intra-luminal placement of conventional guidewires or treatment devices beyond peripheral artery chronic total occlusions (CTOs)
Read the detailed description
Single-arm, multi-center, pivotal study to assess the efficacy and safety of the FastWire System in patients who have a chronic total occlusion in their peripheral vasculature causing an ischemic limb. The enrollment will consist of up to 65 patients meeting the inclusion/exclusion criteria.
- Being tested
- FastWire System - Peripheral
- Keywords
- Chronic Total Occlusion, Peripheral, CTO, FastWire System, FastWire wire, intra-luminal, Active wire, Procedure, Device, peripheral vascular disease, critical limb ischemia, CLI, CLTI, critical limb threatening ischemia
- Medical subject headings
- Peripheral Vascular Diseases, Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FastWire System - PeripheralDevice
The Investigator can use the FastWire System during the procedure to cross CTO Caps and/or to cross multiple lesions.
| Study group | Role | What they receive |
|---|---|---|
| FastWire System - Peripheral | Experimental | This study is to assess the safety and efficacy of the FastWire System. It is intended to assess that the FastWire System can facilitate the intra-luminal placement of conventional guidewires or treatment devices beyond peripheral artery chronic total occlusions (CTOs). Receives: Device: FastWire System - Peripheral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success (On Day of Procedure)
Ability to facilitate treatment of the target lesion using the FastWire as a crossing device only and by allowing additional devices to cross the CTO as required. This will be angiographically confirmed.
Measured: Day 1
Freedom from Serious Adverse Events
Freedom from Serious Adverse Events related to the use of the FastWire System, at 30 days post procedure:
- Cardiovascular deaths.
- Vessel dissection (Grade C or greater) requiring an intervention to resolve.
- Unplanned index limb amputation.
- Symptomatic distal embolization is defined as clinical signs or symptoms of distal emboli detected in the treated limb distal to the treated lesion after the index procedure or noted angiographically after the index procedure and requiring mechanical or pharmacologic means to improve flow.
Measured: Up to Day 30
Secondary outcomes (6)
Technical success (On Day of Procedure)
Ability of the FastWire System to be successfully delivered to, cross through, and retrieved from angiographically confirmed chronic total occlusions.
Measured: Day 1
SADE (Up to Day 30)
Freedom from Serious Adverse Device Effects (SADE).
Measured: Up to Day 30
Vessel dissection or bleeding (Within 24 Hours, Max 36 hrs)
Freedom from Vessel dissection (Grade C or greater) or bleeding within 24 hours (maximum 36 hours) of the index procedure.
Measured: Within 24 Hours, Max 36 hrs
Traverse the CTO (On Day of Procedure)
Ability of the FastWire wire to fully traverse the CTO with entry into the distal true lumen without the need for additional guidewires and/or re-entry devices.
Measured: Day 1
Procedural success (On Day of Procedure)
Procedural success, defined as achievement of technical success together with post-procedural patency. Post-procedural patency is defined as less than or equal to 50% residual percent diameter stenosis assessed by visual estimate at the end of the revascularization procedure.
Measured: Day 1
Procedure-related mortality (Up to Day 7 & Day 30)
All procedure related mortality at day 7 post procedure, and all-cause mortality at 30 days post procedure.
Measured: Up to Day 7 & Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start5 Nov 2024
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Total Occlusion of Artery of the ExtremitiesStudies 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
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Versono Medical Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06492733
- Sponsor's protocol ID
- CIP002FREEFLOW PIVOTAL
- Status last verified
- Aug 2026
- First submitted
- 1 Jul 2024
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pivotal, Single-arm, Multi-centre, Prospective Clinical Investigation to Assess the Efficacy and Safety of the FastWire REvascularisation of Extremities, (For LOWer Limbs) (FREEFLOW).
- ClinicalTrials.gov ID
- NCT06492733
- Acronym / sponsor ID
- CIP002FREEFLOW PIVOTAL
- Keywords
- Chronic Total Occlusion, Peripheral, CTO, FastWire System, FastWire wire, intra-luminal, Active wire, Procedure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Versono Medical LtdIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 9 Jul 2024 (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 study is to assess the safety and efficacy of the FastWire System. It is intended to assess that the FastWire System can facilitate the intra-luminal placement of conventional guidewires or treatment devices beyond peripheral artery chronic total occlusions (CTOs)
Detailed description
Single-arm, multi-center, pivotal study to assess the efficacy and safety of the FastWire System in patients who have a chronic total occlusion in their peripheral vasculature causing an ischemic limb. The enrollment will consist of up to 65 patients meeting the inclusion/exclusion criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FastWire System - Peripheral | Experimental | Device: FastWire System - PeripheralThis study is to assess the safety and efficacy of the FastWire System. It is intended to assess that the FastWire System can facilitate the intra-luminal placement of conventional guidewires or treatment devices beyond peripheral artery chronic total occlusions (CTOs). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (24 listed)
- Subjects who meet any of the following criteria are not eligible for this clinical investigation:
- Life expectancy of less than 12 months.
- Females who are pregnant or lactating (urine test for women of childbearing age).
- Myocardial infarction or stroke in two months prior to the index procedure.
- Known, unstable coronary artery disease or other, uncontrolled comorbidity.
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 |
|---|---|---|
| FastWire System - PeripheralThe Investigator can use the FastWire System during the procedure to cross CTO Caps and/or to cross multiple lesions. | Device | FastWire System - Peripheral |
Primary outcome
Clinical success (On Day of Procedure)
Time frame: Day 1
Ability to facilitate treatment of the target lesion using the FastWire as a crossing device only and by allowing additional devices to cross the CTO as required. This will be angiographically confirmed.
Freedom from Serious Adverse Events
Time frame: Up to Day 30
Freedom from Serious Adverse Events related to the use of the FastWire System, at 30 days post procedure: * Cardiovascular deaths. * Vessel dissection (Grade C or greater) requiring an intervention to resolve. * Unplanned index limb amputation. * Symptomatic distal embolization is defined as clinical signs or symptoms of distal emboli detected in the treated limb distal to the treated lesion after the index procedure or noted angiographically after the index procedure and requiring mechanical or pharmacologic means to improve flow.
6 secondary outcomes
Technical success (On Day of Procedure)
Time frame: Day 1
SADE (Up to Day 30)
Time frame: Up to Day 30
Vessel dissection or bleeding (Within 24 Hours, Max 36 hrs)
Time frame: Within 24 Hours, Max 36 hrs
Traverse the CTO (On Day of Procedure)
Time frame: Day 1
Procedural success (On Day of Procedure)
Time frame: Day 1
Procedure-related mortality (Up to Day 7 & Day 30)
Time frame: Up to Day 7 & Day 30
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 20 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Chronic Total Occlusion of Artery of the Extremities
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FastWire System - Peripheral in people with Chronic Total Occlusion of Artery of the Extremities, run by Versono Medical Ltd at 6 sites in United States.
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 0 inclusion and 24 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 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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 Hugh O'Donoghue Chief Technology Officer (212-252-2059, hugh.odonoghue@versono.life), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical success (On Day of Procedure) (time frame: Day 1). 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 20 Aug 2026.