Clinical trial NCT05869435: FastWire REvascularisation of Extremities, (For LOWer Limbs) - Feasibility Study (FREEFLOW)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Total Occlusion of Arteries of the Extremities
Keywords: Chronic Total Occlusion
Peripheral
CTO
FastWire System
FastWire Guidewire
intra-luminal
Active wire
Procedure
Device
Lead sponsor: Versono Medical Ltd
Sponsor class: INDUSTRY
First posted: 2023-05-22
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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)

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.

Eligibility criteria: Inclusion Criteria:

1. The patient, or the patient's legal guardian has signed and dated an Informed Consent Form.
2. Aged between 18 years and 85 years (inclusive).
3. Severe claudication assessed as Rutherford category 3 or CLTI assessed as Rutherford category 4 or 5 LEAD.
4. Angiographic confirmation of a de novo, CTO, infrainguinal ligament including above the knee, below the knee, or below the ankle vessels.

Exclusion Criteria:

1. Life expectancy of less than 12 months.
2. Females who are pregnant or lactating (urine test for women of childbearing age).
3. Myocardial infarction or stroke in two months prior to the index procedure.
4. Known, unstable coronary artery disease or other, uncontrolled comorbidity.
5. Any known haemorrhagic or coagulation deficiency.
6. Evidence of active infection, including but not limited to the target limb.
7. Current use of cocaine or other substance of abuse.
8. Patients who have received any thrombolytic therapy in the last two weeks.
9. History of severe allergy or contraindication, to contrast medium or other medications used during or after endovascular therapy.
10. Subject participating in another study involving an investigational drug or device
11. Patient has surgery or vascular intervention planned within 30 days of the index procedure.
12. Patient has had a previous peripheral bypass that includes the target vessel.
13. Patient has had a previous intervention in the target CTO (angioplasty, stenting) including at time of index procedure.
14. Patient tests positive for coronavirus disease (COVID-2019), as per site standard practice.
15. Estimated Glomerular Filtration Rate (eGFR) of less than 30 ml/min.
16. Platelet count \< 50,000.

Primary outcomes:
measure: Technical Success (On Procedure Day)
timeFrame: Day 1
measure: Clinical success (On Procedure Day)
timeFrame: Day 1
measure: Freedom from Serious Adverse Events related to the use of FastWire, at 30 days post procedure:
timeFrame: Up to Day 30
Secondary outcomes:
measure: Freedom from Serious Adverse Device Effects (SADE) (Up to Day 30)
timeFrame: Up to Day 30
measure: Freedom from Vessel dissection or bleeding (Within 24 Hours)
timeFrame: Within 24 Hours
measure: Procedural success (On Procedure Day)
timeFrame: Day 1
measure: Procedure related mortality (Up to Day 7 & Day 30)
timeFrame: Up to Day 7 & Day 30
Other outcomes:
Locations:
city: Santo Domingo
country: Dominican Republic
facility: INDEN
Study officials:
References: