Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-24 @ 9:25 PM
NCT ID:
NCT06929832
Eligibility Criteria:
Inclusion Criteria:
1. Subject is at least 18 years of age
2. Subject or authorized representative has signed a written Informed Consent
3. Subject is willing to comply with the protocol requirements
4. Rutherford classification 4-6
5. Planned intervention of the native infrapopliteal arteries using balloon angioplasty, atherectomy, and endovascular procedures.
6. Reference vessel diameter for intended location of the distal tip funnel deployment for the Protexus catheter is ≥3.5mm and ≤6.0mm by visual estimate
7. Inflow arteries have ≤30% stenosis. Inflow arteries can be treated at the time of the study procedure to achieve ≤30% stenosis
Exclusion Criteria:
1. Prior intervention within 30 days of treatment in the planned deployment site for the Protexus catheter
2. Presence of a stent in the planned deployment site for the Protexus catheter
3. Has perforation, dissection, or other injury of the access vessel or Protexus catheter deployment site requiring additional stenting or surgical intervention before enrollment
4. History of bleeding diathesis or coagulopathy and unable to receive standard anticoagulation during the index procedure
5. Acute limb ischemia defined as onset of symptoms within two weeks of the planned intervention
6. Inflow arteries have \>30% stenosis after treatment at the time of the study procedure
7. Pregnant female subject or subject that has a positive pregnancy test within the previous 7 days
8. Known hypersensitivity or allergy to nitinol
9. Target blood vessels are infected, have extreme tortuosity, or are occluded with calcified material
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06929832
Study Brief:
Protocol Section:
NCT06929832