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

Michael D. Dake, Dierk Scheinert, Gunnar Tepe, Jörg Tessarek, Fabrizio Fanelli, Marc Bosiers, Christof Ruhlmann, Zaza Kavteladze, Aaron E. Lottes, Anthony O. Ragheb, Thomas Zeller

Research output: Contribution to journalArticle

141 Scopus citations

Abstract

Purpose: To report a prospective, single-arm, multicenter clinical study evaluating the Zilver PTX drug-eluting stent for treating the above-the-knee femoropopliteal segment (NCT01094678; http://www.clinicaltrials.gov). Methods: The Zilver PTX drug-eluting stent is a self-expanding nitinol stent with a polymer-free paclitaxel coating. Patients with symptomatic (Rutherford category 2-6) de novo or restenotic lesions (including in-stent stenosis) of the above-the-knee femoropopliteal segment were eligible for enrollment. Between April 2006 and June 2008, 787 patients (578 men; mean age 66.6±9.5 years) were enrolled at 30 international sites. Results: Nine hundred lesions (24.3% restenotic lesions of which 59.4% were in-stent stenoses) were treated with 1722 Zilver PTX stents; the mean lesion length was 99.5682.1 mm. The 12-month Kaplan-Meier estimates included an 89.0% event-free survival rate, an 86.2% primary patency rate, and a 90.5% rate of freedom from target lesion revascularization. There were no paclitaxel-related adverse events reported. The 12-month stent fracture rate was 1.5%. The ankle-brachial index, Rutherford score, and walking distance/speed scores significantly improved (p<0.001) from baseline to 12 months. Conclusions: These results indicate that the Zilver PTX drug-eluting stent is safe for treatment of patients with de novo and restenotic lesions of the above-the-knee femoropopliteal segment. At 1 year, the overall anatomical and clinical effectiveness results suggest that this stent is a promising endovascular therapy.

Original languageEnglish (US)
Pages (from-to)613-623
Number of pages11
JournalJournal of Endovascular Therapy
Volume18
Issue number5
DOIs
StatePublished - Oct 1 2011
Externally publishedYes

Keywords

  • Drug-eluting stent
  • In-stent stenosis
  • Paclitaxel-eluting stent
  • Peripheral vascular disease
  • Popliteal artery
  • Restenosis
  • Stenosis
  • Superficial femoral artery

ASJC Scopus subject areas

  • Surgery
  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

Fingerprint Dive into the research topics of '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'. Together they form a unique fingerprint.

  • Cite this