Chronic Total Occlusion of Arteries of the ExtremitiesNCT05869435
FastWire REvascularisation of Extremities, (For LOWer Limbs) - Feasibility Study (FREEFLOW)
A study testing FastWire System Device - Peripheral in people with Chronic Total Occlusion of Arteries of the Extremities, run by Versono Medical Ltd at 1 site in Dominican Republic.
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 Arteries of the Extremities
- What is being tested?
- FastWire System Device - Peripheral
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteDominican Republic
- Study dates
- 14 Dec 2022to 17 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- The patient, or the patient's legal guardian has signed and dated an Informed Consent Form.
- Aged between 18 years and 85 years (inclusive).
- Severe claudication assessed as Rutherford category 3 or CLTI assessed as Rutherford category 4 or 5 LEAD.
- Angiographic confirmation of a de novo, CTO, infrainguinal ligament including above the knee, below the knee, or below the ankle vessels.
Who cannot join
- 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.
- Evidence of active infection, including but not limited to the target limb.
Show all 16Show fewer
- Current use of cocaine or other substance 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 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.
- Platelet count < 50,000.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A First-in-human, Single-arm, Single-center, Feasibility Study 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
A first-in-human, single-arm, single-center, feasibility 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 10 patients meeting the inclusion/exclusion criteria.
- Being tested
- FastWire System Device - Peripheral
- Keywords
- Chronic Total Occlusion, Peripheral, CTO, FastWire System, FastWire Guidewire, intra-luminal, Active wire, Procedure, Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FastWire System Device - 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 | Other | 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). This is a First in Human study Receives: Device: FastWire System Device - Peripheral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Success (On Procedure Day)
Ability of the FastWire to successfully cross angiographically confirmed chronic total occlusions and provide a platform for delivery of other treatment devices.
Measured: Day 1
Clinical success (On Procedure Day)
Clinical success is assessed as the angiographically confirmed passage of the FastWire tip through the lesion and the successful delivery and retrieval of FastWire and the delivery of a treatment device to the target site.
Measured: Day 1
Freedom from Serious Adverse Events related to the use of FastWire, at 30 days post procedure:
- Cardiovascular deaths.
- Vessel dissection requiring an intervention to resolve.
- Unplanned index limb amputation.
- Symptomatic distal embolization.
Measured: Up to Day 30
Secondary outcomes (4)
Freedom from Serious Adverse Device Effects (SADE) (Up to Day 30)
Freedom from Serious Adverse Device Effects (SADE).
Measured: Up to Day 30
Freedom from Vessel dissection or bleeding (Within 24 Hours)
Freedom from Vessel dissection or bleeding within 24 hours (16-36 hours) of index procedure.
Measured: Within 24 Hours
Procedural success (On Procedure Day)
Procedural success, defined as achievement of technical success together with post procedure patency (less than 50% residual diameter stenosis of target vessel patent as assessed by angiographic imaging post device retrieval.
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 posted22 May 2023
- Study start14 Dec 2022
- Primary completion16 Dec 2022
- Study completion17 Jan 2023
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 Arteries 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Versono Medical Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05869435
- Sponsor's protocol ID
- CIP001FREEFLOW
- Status last verified
- Dec 2025
- First submitted
- 11 May 2023
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-human, Single-arm, Single-center, Feasibility Study to Assess the Efficacy and Safety of the FastWire REvascularisation of Extremities, (For LOWer Limbs) (FREEFLOW)
- ClinicalTrials.gov ID
- NCT05869435
- Acronym / sponsor ID
- CIP001FREEFLOW
- Keywords
- Chronic Total Occlusion, Peripheral, CTO, FastWire System, FastWire Guidewire, intra-luminal, Active wire, Procedure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Versono Medical LtdIndustry (pharma, biotech, devices)
- Study start
- 14 Dec 2022 (actual)
- Primary completion
- 16 Dec 2022 (actual)
- Study completion
- 17 Jan 2023 (actual)
- First posted
- 22 May 2023 (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
A first-in-human, single-arm, single-center, feasibility 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 10 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 | Other | Device: FastWire System Device - 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). This is a First in Human study |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patient, or the patient's legal guardian has signed and dated an Informed Consent Form.
- Aged between 18 years and 85 years (inclusive).
- Severe claudication assessed as Rutherford category 3 or CLTI assessed as Rutherford category 4 or 5 LEAD.
- Angiographic confirmation of a de novo, CTO, infrainguinal ligament including above the knee, below the knee, or below the ankle vessels.
Key exclusion criteria (16 listed)
- 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.
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 Device - 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
Technical Success (On Procedure Day)
Time frame: Day 1
Ability of the FastWire to successfully cross angiographically confirmed chronic total occlusions and provide a platform for delivery of other treatment devices.
Clinical success (On Procedure Day)
Time frame: Day 1
Clinical success is assessed as the angiographically confirmed passage of the FastWire tip through the lesion and the successful delivery and retrieval of FastWire and the delivery of a treatment device to the target site.
Freedom from Serious Adverse Events related to the use of FastWire, at 30 days post procedure:
Time frame: Up to Day 30
* Cardiovascular deaths. * Vessel dissection requiring an intervention to resolve. * Unplanned index limb amputation. * Symptomatic distal embolization.
4 secondary outcomes
Freedom from Serious Adverse Device Effects (SADE) (Up to Day 30)
Time frame: Up to Day 30
Freedom from Vessel dissection or bleeding (Within 24 Hours)
Time frame: Within 24 Hours
Procedural success (On Procedure Day)
Time frame: Day 1
Procedure related mortality (Up to Day 7 & Day 30)
Time frame: Up to Day 7 & Day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Chronic Total Occlusion of Arteries of the Extremities
Not yet recruiting
Rotational Atherectomy and Drug-Coated Balloon Angioplasty With Embolic Protection for Superficial Femoral Artery Occlusions
Peripheral Artery Disease, Atherectomy in Diseased Lower Extremity Arteries
Recruiting
FastWire REvascularisation of Extremities, (For LOWer Limbs) - FREEFLOW
Chronic Total Occlusion of Artery of the Extremities
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FastWire System Device - Peripheral in people with Chronic Total Occlusion of Arteries of the Extremities, run by Versono Medical Ltd at 1 site in Dominican Republic.
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 4 inclusion and 16 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: finished, as of the sponsor's last update on 11 Dec 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 Dominican Republic. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical Success (On Procedure Day) (time frame: Day 1). The study lists 3 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 11 Dec 2025.