POst-Market ClINical Follow-up STudy oF the SerranatOR PTA Serration Balloon CathEter
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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…
Interventions
- DevicePeripheral balloon angioplasty
Serration balloon angioplasty of iliac, femoral, iliofemoral, popliteal, infrapopliteal and pedal arteries, or dysfunctional native or synthetic arteriovenous dialysis fistula
Locations (19)
- HonorHealthScottsdale, Arizona
- Cedars-Sinai Medical CenterLos Angeles, California
- Hartford HealthCareHartford, Connecticut
- MedStar Washington Hospital / MedStar MontgomeryWashington D.C., District of Columbia
- Manatee MemorialBradenton, Florida
- Radiology and Imaging SpecialistsLakeland, Florida