NCT06687590

Serranator POINT FORCE Registry

POst-Market ClINical Follow-up STudy of the SerranatOR PTA Serration Balloon CathEter

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Cagent Vascular LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

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

Timeline

• Start date: 2025-01-22
• Primary completion: 2026-08-31
• Completion: 2026-12-31
• First posted: 2024-11-13
• Last updated: 2025-02-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study