Zilver® PTX™ Global Registry

Conditions

Peripheral Arterial Disease, Peripheral Vascular Disease

Keywords

Peripheral Aterial Disease (PAD), Peripheral Vascular Disease, Drug-Eluting Stent, Drug-Coated Stent, Vascular Diseases, Cardiovascular Diseases

Brief summary

The Zilver PTX Registry Study is a prospective, non-randomized, open-label, multicenter single-arm study enrolling patients in Europe, Asia, and North America with de novo or restenotic (including in-stent restenosis) lesions of the above-the-knee femoropopliteal artery (SFA). The primary endpoint of the study is event-free survival (EFS) at 6 months.

Michael D. Dake, Fabrizio Fanelli, Aaron E. Lottes, Erin E. O’Leary, Heidi Reichert et al. (12 authors)

CardioVascular and Interventional Radiology2020-10-0614 citations

10.1007/s00270-020-02648-6

Sustained safety and effectiveness of paclitaxel-eluting stents for femoropopliteal lesions: 2-year follow-up from the Zilver PTX randomized and single-arm clinical studies.

Dake MD, Ansel GM, Jaff MR, Ohki T, Saxon RR, Smouse HB, Snyder SA, O'Leary EE, Tepe G, Scheinert D, Zeller T, Zilver PTX Investigators.

2013-04-10238 citations

10.1016/j.jacc.2013.03.034

Treatment of femoropopliteal in-stent restenosis with paclitaxel-eluting stents.

Zeller T, Dake MD, Tepe G, Brechtel K, Noory E, Beschorner U, Kultgen PL, Rastan A.

2013-03-0189 citations

10.1016/j.jcin.2012.12.118

Nitinol stents with polymer-free paclitaxel coating for lesions in the superficial femoral and popliteal arteries above the knee: twelve-month safety and effectiveness results from the Zilver PTX single-arm clinical study.

Dake MD, Scheinert D, Tepe G, Tessarek J, Fanelli F, Bosiers M, Ruhlmann C, Kavteladze Z, Lottes AE, Ragheb AO, Zeller T, Zilver PTX Single-Arm Study Investigators.

2011-10-01112 citations

10.1583/11-3560.1

Interventions

DEVICEZilver® PTX™ Stent

Stenting of the superfemoropopliteal artery.

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* stenosis of the above-the-knee femoropopliteal artery * appropriate size and location of the lesion

Exclusion criteria

* pregnant or breast feeding * failure or inability to give informed consent * simultaneously participating in another drug or device study

Design outcomes

Primary

Measure	Time frame
Event-free Survival	6 months

Countries

Germany, Italy

Outcome results

None listed