Serranator POINT FORCE Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCagent Vascular LLC
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 groupSponsors and collaborators
Cagent Vascular LLC
Lead sponsor
Yale Cardiovascular Research Group
Collaborator
Julius Clinical
Collaborator
Source ClinicalTrials.gov