Registry for the Serranator device in treating peripheral artery disease and dialysis fistula issues

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This registry collects observational data on the safety and performance of the Serranator® device used in treating peripheral artery disease (PAD) and dysfunctional arteriovenous dialysis fistulae. Participants will receive peripheral balloon angioplasty as part of their standard care, and the data gathered will help evaluate the device's effectiveness in real-world scenarios. The study aims to provide clinical evidence that can support future evaluations of the Serranator® in medical practice.

Why it matters

Who can join: the full rules

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.

Where it's running

• HonorHealth
  Scottsdale, Arizona, United States Recruiting
• Cedars-Sinai Medical Center
  Los Angeles, California, United States Recruiting
• Hartford HealthCare
  Hartford, Connecticut, United States Recruiting
• MedStar Washington Hospital / MedStar Montgomery
  Washington D.C., District of Columbia, United States Recruiting
• Manatee Memorial
  Bradenton, Florida, United States Recruiting
• Radiology and Imaging Specialists
  Lakeland, Florida, United States Recruiting

Study contacts

• Study coordinator: Alexis Shewfelt
• Email: ashewfelt33@cagentvascular.com
• Phone: 6502086743

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.