Serranator POINT FORCE Registry

Cagent Vascular LLC500 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Peripheral Artery Disease (PAD)Dysfunctional AV Fistula Dysfunctional AV Graft

Interventions

Peripheral balloon angioplastyDEVICE

Serration balloon angioplasty of iliac, femoral, iliofemoral, popliteal, infrapopliteal and pedal arteries, or dysfunctional native or synthetic arteriovenous dialysis fistula

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

UT Southwestern

Dallas, Texas, United States

RECRUITING

Outcomes

Primary Outcomes

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-procedural

Secondary Outcomes

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-procedural

Central Contacts

Alexis Shewfelt

CONTACT

6502086743 ashewfelt33@cagentvascular.com

Data from ClinicalTrials.gov

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