RECRUITINGOBSERVATIONAL
Serranator POINT FORCE Registry
POst-Market ClINical Follow-up STudy of the SerranatOR PTA Serration Balloon CathEter
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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.
Who Should NOT Join This Trial:
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DEVICE
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