Peripheral Arterial Disease
Conditions
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 standard of care treatment with other therapeutic devices is conducted in patients undergoing infrapopliteal treatment for peripheral arterial disease (PAD).
Interventions
None listed
Sponsors
Protexa Endovascular, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Endpoint | 30 Days | 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 |
Contacts
Primary ContactRyan Balko
Outcome results
None listed