Heart and Vascular Care
The cardiologists and cardiovascular surgeons at Main Line Health work together to improve the detection and prevention of heart disease with the latest treatment options.
Clinical Trials
Clinical Trial Number: POINT FORCE
| Study ID: | POINT FORCE |
|---|---|
| Phase | N/A |
| Physician Investigator(s) | |
| Study Locations |
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.