Post-Market Evaluation of Active Thrombectomy and Proximal Aspiration During Lower Extremity Tibial Interventions
NCT ID: NCT06929832
Last Updated: 2025-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
20 participants
OBSERVATIONAL
2025-04-30
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Protexa Endovascular, Inc.
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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PR-100
Identifier Type: -
Identifier Source: org_study_id
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