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Serranator POINT FORCE Registry

Recruitingn/aAges 18 Years - anyAllCagent Vascular LLC
NCT06687590 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The objective of this registry is to collect observational data under local standard of care and evaluate safety and performance of the Serranator® in treatment of peripheral artery disease (PAD), or dysfunctional native or synthetic arteriovenous dialysis fistulae in a real-world scenario. The data and conclusions derived from this study will be used to provide clinical evidence for the clinical evaluation process.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Subjects intended to be treated with Serranator® for de-novo or restenotic lesions of the iliac, femoral, iliofemoral, popliteal, infrapopliteal and pedal arteries or dysfunctional native or synthetic arteriovenous dialysis fistulae. * Subjects presenting with claudication or critical limb-threatening ischemia (CLTI) by Rutherford Clinical Category 3, 4, 5, or 6 of the target limb. * Age of subject is \> 18. * Subject or subject's legal representative has been informed of the nature of the study, agrees to participate and has signed the approved consent form. Exclusion Criteria: * Subjects with any medical condition that would make him/her an inappropriate candidate for treatment with Serranator® as per Instructions for Use (IFU) or investigator's opinion. * Subject already enrolled in other investigational (interventional) studies that would interfere with study endpoints.
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What it tests

  • Peripheral balloon angioplasty
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Where

19 sites
HonorHealth
Scottsdale, United States
Cedars-Sinai Medical Center
Los Angeles, United States
Hartford HealthCare
Hartford, United States
MedStar Washington Hospital / MedStar Montgomery
Washington D.C., United States
Manatee Memorial
Bradenton, United States
Radiology and Imaging Specialists
Lakeland, United States
Henry Ford Health
Detroit, United States
Barnes Jewish
St Louis, United States

…and 11 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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