Actively Recruiting
FastWire REvascularisation of Extremities, (For LOWer Limbs) - FREEFLOW
Led by Versono Medical Ltd · Updated on 2025-12-11
65
Participants Needed
6
Research Sites
86 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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)
CONDITIONS
Official Title
FastWire REvascularisation of Extremities, (For LOWer Limbs) - FREEFLOW
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Age between 18 and 85 years inclusive
- Severe claudication (Rutherford category 3) or critical limb-threatening ischemia (Rutherford category 4 or 5)
- Angiographic confirmation of a new chronic total occlusion below the origin of the superficial femoral artery, above or below the knee
- Total occlusion length less than 40 cm if multiple CTOs are present
- 100% arterial blockage by visual angiography assessment at procedure
- For below-the-knee CTOs, at least one patent run-off vessel with less than 50% narrowing confirmed by angiography or magnetic resonance angiography at procedure
You will not qualify if you...
- Life expectancy less than 12 months
- Pregnant or lactating females
- Heart attack or stroke within two months before the procedure
- Known unstable coronary artery disease or uncontrolled other serious health conditions
- Any known bleeding or clotting disorder
- Known allergy to nickel, titanium, or their alloys
- Active infection including in the target limb
- Current use of cocaine or other abused substances
- Thrombolytic therapy within the last two weeks
- Severe allergy or contraindication to contrast medium or medications used during or after the procedure
- Participation in another investigational drug or device study
- Planned surgery or vascular intervention within 30 days of the procedure
- Previous peripheral bypass involving the target vessel
- Previous intervention in the target CTO including angioplasty, stenting, or prior attempt during the procedure
- Positive test for COVID-19
- Estimated glomerular filtration rate less than 30 ml/min or creatinine level over 2.5 mg/ml
- Platelet count below 50,000/µL
- For below-the-knee CTOs, absence of at least one patent run-off vessel
- Acute or sub-acute intraluminal thrombus in the target vessel
- Aneurysm twice the reference vessel diameter or larger in the index vessel or certain arteries
- Injury such as perforation or dissection of access or index vessel requiring stenting or surgery before attempting to cross the lesion with the FastWire System
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
EndoVascular Consultants
Wilmington, Delaware, United States, 19805
Actively Recruiting
2
Vascular & Embolization Specialists
Cocoa, Florida, United States, 32926
Actively Recruiting
3
Vascular Institute of the Midwest
Davenport, Iowa, United States, 52807
Actively Recruiting
4
Cardiovascular Institute of the South-ASC
Gray, Louisiana, United States, 70359
Actively Recruiting
5
Dearborn Cardiology
Dearborn, Michigan, United States, 48126
Actively Recruiting
6
Vascular Institute of Chattanooga
Chattanooga, Tennessee, United States, 37421
Actively Recruiting
Research Team
H
Hugh O'Donoghue Chief Technology Officer
CONTACT
L
Lea Doyle Head of Clinical & Regulatory Affairs
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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