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

Not Applicable

Completed

• Conditions: Chronic Total Occlusion of Arteries of the Extremities
• Interventions: Device: FastWire System Device - Peripheral

• Registration Number: NCT05869435
• Lead Sponsor: Versono Medical Ltd

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.

Study Timeline

• Study Start: 2022-12-14
• Primary Completion: 2022-12-16
• Study Completion: 2023-01-17
• Status Verified: 2023-05
• Study First Submitted: 2023-05-11
• Study First Submitted QC: 2023-05-11
• Study First Posted: 2023-05-22
• Last Update Submitted: 2024-05-16
• Last Update Posted: 2024-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FastWire System - Peripheral	FastWire System Device - Peripheral	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

Primary Outcome Measures

Name	Time	Method
Technical Success (On Procedure Day)	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)	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:	Up to Day 30	* Cardiovascular deaths.; * Vessel dissection requiring an intervention to resolve.; * Unplanned index limb amputation.; * Symptomatic distal embolization.

Secondary Outcome Measures

Name	Time	Method
Freedom from Serious Adverse Device Effects (SADE) (Up to Day 30)	Up to Day 30	Freedom from Serious Adverse Device Effects (SADE).
Procedural success (On Procedure Day)	Day 1	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.
Procedure related mortality (Up to Day 7 & Day 30)	Up to Day 7 & Day 30	All procedure related mortality at day 7 post procedure, and all-cause mortality at 30 days post procedure.
Freedom from Vessel dissection or bleeding (Within 24 Hours)	Within 24 Hours	Freedom from Vessel dissection or bleeding within 24 hours (16-36 hours) of index procedure.

Trial Locations

Locations (1)

INDEN; 🇩🇴 Santo Domingo, Dominican Republic