Health Trials

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Peripheral balloon angioplasty

Treatment groups

500 Participants
are divided into 1 treatment group

Locations

19
Arizona
HonorHealth85251, Scottsdale United States
California
Cedars-Sinai Medical Center90048, Los Angeles United States
Connecticut
Hartford HealthCare06102, Hartford United States
District of Columbia
MedStar Washington Hospital / MedStar Montgomery20010, Washington D.C. United States

Sponsors and collaborators

Cagent Vascular LLC

Lead sponsor

Yale Cardiovascular Research Group

Collaborator

Julius Clinical

Collaborator

Source ClinicalTrials.gov