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Interim Report on the Zilver® PTX™ (Drug-Eluting Stenting in the SFA Position) Clinical Study

Michael Dake¹, Gary Ansel² for the Zilver® PTX™ Investigators.
¹University of Virginia Health System, Charlottesville, VA; ²Riverside Methodist Hospital, Columbus, OH.

Objective(s): The Zilver® PTX™ Drug-Eluting Peripheral Stent (DES) is undergoing clinical study to evaluate its potential for improving the treatment of femoropopliteal artery disease.  The clinical study will include more than1000 patients with the DES. Approximately 240 DES patients will be from the Randomized arm of the study, which is currently enrolling 480 patients. Approximately 760 DES patients will be from the Registry arm of the study. Enrollment in the Registry is complete and this is an interim report of outcomes.

Methods: The Zilver® PTX™ Registry is a prospective, multicenter, single-arm study with relatively broad inclusion criteria (e.g., no maximum lesion length, de novo or restentoic lesions, including in-stent restenosis). The endpoints include 6- and 12-month event-free survival (EFS) and freedom from target lesion revascularization (TLR). Imaging includes duplex ultrasound and stent x-ray at 6 and 12 months.
 
Results: The 6- and 12-month data include 435 patients (497 lesions) and 200 patients (245 lesions), respectively. The corresponding EFS rates were 94% and 84%, and freedom from TLR was 96% and 88%. Evaluation of stent x-rays is ongoing and currently suggests fractures in approximately 1% (8/825) of stents at 6 months and less than 2% (11/547) at 12 months.  Clinical measures (ABI, Rutherford score, walking distance and speed scores) showed significant improvement at 6 months, which was maintained through 12 months.

Conclusions: Interim results from the Registry indicate no safety concerns, low fracture rates, high rates of EFS and freedom from TLR, and clinical improvement with the DES.  Ongoing Registry follow-up, as well as the Randomized study, will continue to evaluate the performance of the Zilver® PTX™ Drug-Eluting Stent.

Disclosure Block:
M. Dake, Cook, W.L. Gore, Medtronic, Abbot Vascular; G. Ansel, Abbot/Guidant Vascular, Access Closure, AngioSlide Ltd., Atheromed, Bacchus, Inc, BARD Inc, Biocardia, Boston Scientific, Cook, Inc., Cordis Johnson & Johnson, Edwards Lifesciences, ev3, ICON Interventional Systems, Inc., Invatec, Lumen Biomedical, Medical Simulation, MEDRAD, Medtronic, Nellix, Inc., Omnisonics, Ostial Solutions, Paragon IP, Pathway Medical, Possis Medical, Inc, SimSuite, Spectranetics, Square One, Vascular Performance Products, VIVA Physicians, Inc., Wind Crest LLC, W.L. Gore.