Serranator POINT FORCE Registry

Cagent Vascular

Status: Not yet enrolling

Conditions: Peripheral Artery Disease (PAD); Dysfunctional AV Graft; Dysfunctional AV Fistula

Treatments: Device: Peripheral balloon angioplasty

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06687590

CSP-0696

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

500 participants in 1 patient group

Subjects

Description:

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.

Treatment:

Device: Peripheral balloon angioplasty