RECRUITING

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

Conditions

Chronic Total Occlusion of Artery of the Extremities Chronic Total Occlusion Peripheral CTO FastWire System FastWire wire intra-luminal Active wire Procedure Device

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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)

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).

Quick Facts

Study Start:2024-11-05

Study Completion:2025-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06492733

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. The patient 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.	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. Known sensitivity to nickel, titanium, or their alloys. 7. Evidence of active infection, including but not limited to the target limb. 8. Current use of cocaine or other substances of abuse. 9. Patients who have received any thrombolytic therapy in the last two weeks. 10. History of severe allergy or contraindication, to contrast medium or other medications used during or after endovascular therapy. 11. Subject participating in another study involving an investigational drug or device. 12. Patient has surgery or vascular intervention planned within 30 days of the index procedure. 13. Patient has had a previous peripheral bypass that includes the target vessel. 14. Patient has had a previous intervention in the target CTO (angioplasty, stenting) including previous attempt at time of index procedure. 15. Patient tests positive for coronavirus disease (COVID-2019), as per site standard practice. 16. Estimated Glomerular Filtration Rate (eGFR) of less than 30 ml/min or creatine level \>2.5mg/ml. 17. Platelet count \< 50,000/μL. 1. 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. 2. Has an acute or sub-acute intraluminal thrombus within the target vessel. 3. Aneurysm distal to puncture access site at least twice the reference vessel diameter, located in the index vessel, abdominal aorta, iliac, or popliteal. 4. 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.

Inclusion Criteria

Exclusion Criteria

1. The patient 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.

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. Known sensitivity to nickel, titanium, or their alloys.
7. Evidence of active infection, including but not limited to the target limb.
8. Current use of cocaine or other substances of abuse.
9. Patients who have received any thrombolytic therapy in the last two weeks.
10. History of severe allergy or contraindication, to contrast medium or other medications used during or after endovascular therapy.
11. Subject participating in another study involving an investigational drug or device.
12. Patient has surgery or vascular intervention planned within 30 days of the index procedure.
13. Patient has had a previous peripheral bypass that includes the target vessel.
14. Patient has had a previous intervention in the target CTO (angioplasty, stenting) including previous attempt at time of index procedure.
15. Patient tests positive for coronavirus disease (COVID-2019), as per site standard practice.
16. Estimated Glomerular Filtration Rate (eGFR) of less than 30 ml/min or creatine level \>2.5mg/ml.
17. Platelet count \< 50,000/μL.
1. 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.
2. Has an acute or sub-acute intraluminal thrombus within the target vessel.
3. Aneurysm distal to puncture access site at least twice the reference vessel diameter, located in the index vessel, abdominal aorta, iliac, or popliteal.
4. 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.

Contacts and Locations

Study Contact

Chief Technology Officer

CONTACT

12122522059

hugh.odonoghue@versono.life

Study Locations (Sites)

Vascular Institute of the Midwest

Davenport, Iowa, 52807

United States

Cardiovascular Institute of the South-ASC

Gray, Louisiana, 70359

United States

Vascular Institute of Chattanooga

Chattanooga, Tennessee, 37421

United States

Collaborators and Investigators

Sponsor: Versono Medical Ltd

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-05

Study Completion Date2025-10

Study Record Updates

Study Start Date2024-11-05

Study Completion Date2025-10

Terms related to this study

Keywords Provided by Researchers

Chronic Total Occlusion
Peripheral
CTO
FastWire System
FastWire wire
intra-luminal
Active wire
Procedure
Device

Additional Relevant MeSH Terms

Chronic Total Occlusion of Artery of the Extremities