Serranator POINT FORCE Registry

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Jan 22, 2025

Status verified

May 2026

Primary completion

Jun 30, 2026

Completion

Aug 31, 2026

Study Design

Enrollment

500 participants (estimated)

Arms

• Arm: Subjects
  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.

Primary Outcome Measure

Performance Endpoint [ Time Frame: Peri-procedural ]

Central Contacts

• Alexis Shewfelt
  6502086743
  [email protected]

Locations (19)

Find similar trials in Scottsdale, AZ

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