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New treatment option for Chronic Total Occlusion of Artery of the Extremities
Official title FastWire REvascularisation of Extremities, (For LOWer Limbs) - FREEFLOW
ClinicalTrials.gov ID: NCT06492733
What this study is testing
- What it's testing
- 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)
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- General people who meet all the following criteria are eligible for this clinical investigation:
- The patient signed and dated an Informed Consent Form.
- Aged between 18 years and 85 years (inclusive).
- Severe claudication assessed as Rutherford category 3 or CLTI assessed as Rutherford category 4 or 5 LEAD. Angiographic Unless otherwise specified...
- Angiographic confirmation at the time of the procedure of a de novo CTO below the origin of the superficial femoral artery (SFA) including above the...
You likely can't join if
- people who meet any of the following criteria are not eligible for this clinical investigation:
- Life expectancy of less than 12 months.
- Females who are pregnant or lactating (urine test for women of childbearing age).
- Myocardial infarction or stroke in two months prior to the index procedure.
- Known, unstable coronary artery disease or other, uncontrolled comorbidity.
- Any known haemorrhagic or coagulation deficiency.
See the full eligibility criteria
- General people who meet all the following criteria are eligible for this clinical investigation:
- The patient signed and dated an Informed Consent Form.
- Aged between 18 years and 85 years (inclusive).
- Severe claudication assessed as Rutherford category 3 or CLTI assessed as Rutherford category 4 or 5 LEAD. Angiographic Unless otherwise specified, the Investigator performing the procedure bases angiographic inclusion...
- Angiographic confirmation at the time of the procedure of a de novo CTO below the origin of the superficial femoral artery (SFA) including above the knee or below the knee. (Note: Multilevel CTOs are included as long as...
- 100% stenosis by a visual estimate of angiography at the time of procedure.
- For below-the-knee CTOs, the target limb shall have at least one patent (\<50% stenosis) run-off vessel confirmed by angiography or magnetic resonance angiography at the time of the procedure.
- people who meet any of the following criteria are not eligible for this clinical investigation:
- Life expectancy of less than 12 months.
- Females who are pregnant or lactating (urine test for women of childbearing age).
- Myocardial infarction or stroke in two months prior to the index procedure.
- Known, unstable coronary artery disease or other, uncontrolled comorbidity.
- Any known haemorrhagic or coagulation deficiency.
- Known sensitivity to nickel, titanium, or their alloys.
- Evidence of active infection, including but not limited to the target limb.
- Current use of cocaine or other substances of abuse.
- Patients who have received any thrombolytic therapy in the last two weeks.
- History of severe allergy or contraindication, to contrast medium or other medications used during or after endovascular therapy.
- Subject participating in another study involving an investigational drug or device.
- Patient has surgery or vascular intervention planned within 30 days of the index procedure.
- Patient has had a previous peripheral bypass that includes the target vessel.
- Patient has had a previous intervention in the target CTO (angioplasty, stenting) including previous attempt at time of index procedure.
- Patient tests positive for coronavirus disease (COVID-2019), as per site standard practice.
- Estimated Glomerular Filtration Rate (eGFR) of less than 30 ml/min or creatine level \>2.5mg/ml.
- Platelet count \< 50,000/μL. Angiographic Exclusion Criteria Unless otherwise specified, the Investigator performing the procedure bases angiographic exclusion on a visual determination of qualification imaging taken at...
- 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.
- Has an acute or sub-acute intraluminal thrombus within the target vessel.
- Aneurysm distal to puncture access site at least twice the reference vessel diameter, located in the index vessel, abdominal aorta, iliac, or popliteal.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Wilmington, Delaware, United States
- Cocoa, Florida, United States
- Davenport, Iowa, United States
- Gray, Louisiana, United States
- Dearborn, Michigan, United States
- Chattanooga, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wilmington, Delaware, United States; Cocoa, Florida, United States; Davenport, Iowa, United States; Gray, Louisiana, United States; Dearborn, Michigan, United States; Chattanooga, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.