Status:
NOT_YET_RECRUITING
Post-Market Evaluation of Active Thrombectomy and Proximal Aspiration During Lower Extremity Tibial Interventions
Lead Sponsor:
Protexa Endovascular, Inc.
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
18+ years
Brief Summary
Post-Market Evaluation of Active Thrombectomy and Proximal Aspiration during Lower Extremity Tibial Interventions
Detailed Description
This is a prospective, multi-center, non-randomized, open label, single arm post-market clinical study to gather data on the use of the Protexus catheter for temporary blood vessel occlusion while sta...
Eligibility Criteria
Inclusion
- Subject is at least 18 years of age
- Subject or authorized representative has signed a written Informed Consent
- Subject is willing to comply with the protocol requirements
- Rutherford classification 4-6
- Planned intervention of the native infrapopliteal arteries using balloon angioplasty, atherectomy, and endovascular procedures.
- 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
- Inflow arteries have ≤30% stenosis. Inflow arteries can be treated at the time of the study procedure to achieve ≤30% stenosis
Exclusion
- Prior intervention within 30 days of treatment in the planned deployment site for the Protexus catheter
- Presence of a stent in the planned deployment site for the Protexus catheter
- Has perforation, dissection, or other injury of the access vessel or Protexus catheter deployment site requiring additional stenting or surgical intervention before enrollment
- History of bleeding diathesis or coagulopathy and unable to receive standard anticoagulation during the index procedure
- Acute limb ischemia defined as onset of symptoms within two weeks of the planned intervention
- Inflow arteries have \>30% stenosis after treatment at the time of the study procedure
- Pregnant female subject or subject that has a positive pregnancy test within the previous 7 days
- Known hypersensitivity or allergy to nitinol
- Target blood vessels are infected, have extreme tortuosity, or are occluded with calcified material
Key Trial Info
Start Date :
April 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06929832
Start Date
April 1 2025
End Date
December 1 2025
Last Update
April 16 2025
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