Serranator POINT FORCE Registry

Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Device: Peripheral balloon angioplasty
    Serration balloon angioplasty of iliac, femoral, iliofemoral, popliteal, infrapopliteal and pedal arteries, or dysfunctional native or synthetic arteriovenous dialysis fistula

Recruiting Locations

MedStar Washington Hospital / MedStar Montgomery
Washington D.C., District of Columbia 20010
Contact:
Kassaye Sesaba
202-877-8475
kassaye.s.sesaba@medstar.net

More Details

Status
Recruiting
Sponsor
Cagent Vascular LLC

Study Contact

Alexis Shewfelt
6502086743
ashewfelt33@cagentvascular.com