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New wire device aims to unclog leg arteries without surgery
NCT ID NCT05869435
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early study tested a new tool called the FastWire System in 8 people with severely blocked leg arteries. The goal was to see if the device could safely cross the blockage and allow doctors to place other treatments to restore blood flow. The study focused on safety and whether the device worked as intended during the procedure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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8 people
The number who actually took part.
- Started
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Dec 2022
- Finished
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Jan 2023
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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INDEN
Santo Domingo, Dominican Republic