FastWire REvascularisation of Extremities, (For LOWer Limbs) - Feasibility Study (FREEFLOW)

Versono Medical

Status: Completed

Conditions: Chronic Total Occlusion of Arteries of the Extremities

Treatments: Device: FastWire System Device - Peripheral

Study type: Interventional

Funder types: Industry

Identifiers

NCT05869435

CIP001FREEFLOW

Details and patient eligibility

About

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)

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

FastWire System - Peripheral

Other group

Description:

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

Treatment:

Device: FastWire System Device - Peripheral