The Zilver PTX Drug-Eluting Peripheral Stent is proven in the most rigorous SFA studies ever conducted. The exhaustive registry study included 902 lesions, 791 patients, 30 sites, and 13 countries. As a result Zilver PTX was shown to reduce reinterventions by 50% over leading competitors. This is especially impressive considering these success rates remained consistent in challenging cases ranging from existing in-stent restenosis to long lesions to diabetic patients.

 

Largest Level I Randomized Study (480 patients)

1. United States, Japan and Germany
2. Patients treated with PTA or Zilver PTX stents
3. Enrollment complete
1. If PTA failure, 2nd randomization to Zilver PTX or Zilver Flex™

480 patients enrolled at 55 centers

Relatively simple SFA lesions

1. Lesions up to 14 cm
2. Up to 4 DES per patient
3. No previous stent in target vessel

Primary endpoint at 12 months

1. Follow-up for 5 years

Prospective study, closely monitored and independently adjudicated

 

Largest Level IIb Registry Study (791 patients)

1. Europe, Russia, Canada and Korea
2. Patients treated with Zilver PTX stents
3. Enrollment complete

Includes complex SFA lesions (nearly "all comers")

1. Rutherford category 2 or greater
2. No lesion length limitation
3. Up to 4 DES per patient
4. Multiple lesions per leg
5. All lesion types (including restenosis)

Target lesion revascularization (TLR) defined as: Clinically driven reintervention for ≥ 50% diameter stenosis within treated segment (including ± 5 mm), or surgical bypass of target vessel.

Next Section: Polymer-Free Paclitaxel Delivery »

 

TLR Registry Comparison

Registry Lesion Characteristics

Freedom from TLR