Post-Market Evaluation of Active Thrombectomy and Proximal Aspiration During Lower Extremity Tibial Interventions

NCT06929832 | Not Yet Recruiting

• 1 other identifier: PR-100
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Post-Market Evaluation of Active Thrombectomy and Proximal Aspiration during Lower Extremity Tibial Interventions

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Primary Endpoint

  The incidence, type, and severity of Protexus related major adverse events (MAEs) through 30-days defined as: * Death or organ injury * Thrombosis, pseudo-aneurysm, dissection (grade C or greater by visual assessment) or clinical perforation at the Protexus device location * Angiographically evident flow limiting distal embolization

  30 Days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects being treated for PAD with standard of care interventions

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Protexa Endovascular, Inc.: lead

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Central Study Contacts

Ryan Balko

CONTACT

612-251-2526; ryan@vdcmedtech.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 16, 2025
• Study Start: April 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 16, 2025

Record last verified: 2025-04