Post-Market Evaluation of Active Thrombectomy and Proximal Aspiration During Lower Extremity Tibial Interventions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Peripheral Arterial Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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).
Primary outcome measures
- Primary Endpoint [Time frame: 30 Days]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06929832 · PR-100