FastWire REvascularisation of Extremities, (For LOWer Limbs) - FREEFLOW
United States65 participantsStarted 2024-11-05
Plain-language 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)
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. 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 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 the total length from the beginning of the most proximal total occlusion to the end of the most distal total occlusion is less than 40 cm.)
✓. 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.
Exclusion criteria
✕. 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.