Post-Market Evaluation of Active Thrombectomy and Proximal Aspiration During Lower Extremity Tibial Interventions (Protexus 1)

April 8, 2025 updated by: Protexa Endovascular, Inc.
Post-Market Evaluation of Active Thrombectomy and Proximal Aspiration during Lower Extremity Tibial Interventions

Study Overview

Status

Not yet recruiting

Conditions

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).

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects being treated for PAD with standard of care interventions

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Endpoint
Time Frame: 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
30 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Protexa Endovascular, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

April 8, 2025

First Submitted That Met QC Criteria

April 8, 2025

First Posted (Actual)

April 16, 2025

Study Record Updates

Last Update Posted (Actual)

April 16, 2025

Last Update Submitted That Met QC Criteria

April 8, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR-100

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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