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
This trial does not accept healthy volunteersQualifiers
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 population
The study population will consist of subjects with claudication or ischemic rest pain, with de novo or restenotic lesions in the iliac, femoral, iliofemoral, popliteal, infrapopliteal and pedal arteries, or dysfunctional native or synthetic arteriovenous dialysis fistulae.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Peripheral balloon angioplasty
DeviceSerration balloon angioplasty of iliac, femoral, iliofemoral, popliteal, infrapopliteal and pedal arteries, or dysfunctional native or synthetic arteriovenous dialysis fistula
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: Subjects1 intervention
Trial outcomes
Primary outcomes
1
Performance Endpoint
Device Success defined as the achievement of successful delivery, balloon inflation and deflation, and retrieval of the study device(s) with a post- Serranator® residual stenosis of ≤30% by angiographic core laboratory assessment at the intended target lesion.
Time frame
Peri-proceduralSecondary outcomes
1
Safety Endpoint
Major Adverse Events (MAE) until discharge, defined as all amputations and any re-intervention (surgical or endovascular) in the target limb.
Time frame
Peri-proceduralSponsors and contacts
Click on the lead sponsor to view all of their trials.
Cagent Vascular LLC
Lead sponsor
Yale Cardiovascular Research Group
Collaborator
Julius Clinical
Collaborator
Source ClinicalTrials.gov