Serranator POINT FORCE Registry
POst-Market ClINical Follow-up STudy of the SerranatOR PTA Serration Balloon CathEter
Cagent Vascular LLC
500 participants
Jan 22, 2025
OBSERVATIONAL
Conditions
Summary
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
Inclusion Criteria4
- 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 Criteria2
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Serration balloon angioplasty of iliac, femoral, iliofemoral, popliteal, infrapopliteal and pedal arteries, or dysfunctional native or synthetic arteriovenous dialysis fistula
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06687590