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Serranator POINT FORCE Registry
Sponsor: Cagent Vascular LLC
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.
Official title: POst-Market ClINical Follow-up STudy of the SerranatOR PTA Serration Balloon CathEter
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
500
Start Date
2025-01-22
Completion Date
2026-12-31
Last Updated
2025-02-13
Healthy Volunteers
No
Interventions
Peripheral balloon angioplasty
Serration balloon angioplasty of iliac, femoral, iliofemoral, popliteal, infrapopliteal and pedal arteries, or dysfunctional native or synthetic arteriovenous dialysis fistula
Locations (1)
UT Southwestern
Dallas, Texas, United States