Clinical evaluation of the Zilver vascular stent for symptomatic iliac artery disease

Journal of Vascular and Interventional Radiology : JVIR
Katharine L KrolBarry T Katzen

Abstract

To evaluate the safety and effectiveness of the Zilver vascular stent in the treatment of de novo or restenotic lesions in the external and common iliac arteries. Regardless of the results of an initial percutaneous transluminal angioplasty (PTA), 151 consecutive patients were implanted with Zilver vascular stents (Cook, Bloomington, Ind) in up to two stenotic (< or =10 cm) or occluded (< or =5 cm) atherosclerotic lesions of the external or common iliac arteries. The primary endpoint was the rate of major adverse events within 9 months after the procedure. Major adverse events were defined as death, myocardial infarction, target lesion revascularization, and limb loss. Secondary endpoints included acute procedural success, 30-day clinical success, 9-month patency rate, 9-month functional status (on the basis of the validated Walking Impairment Questionnaire), and ankle-brachial index (ABI). of 1-, 6-, and 9-month follow-up are reported. Results The 9-month device and/or procedural-related major adverse event rate (adjudicated by an independent clinical events committee) was 2.7%. The all-cause major adverse event rate was 7.5%. Both rates were substantially below the prespecified objective performance criterion of 16%. The acut...Continue Reading

References

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Citations

Aug 31, 2010·Journal of Vascular and Interventional Radiology : JVIR·Michael R Jaff, Barry T Katzen
Jul 12, 2013·The British Journal of Surgery·S D GoodeA J Sims
Apr 24, 2014·Journal of Endovascular Therapy : an Official Journal of the International Society of Endovascular Specialists·Daniel G ClairKeith D Dawkins
Feb 9, 2013·Journal of Endovascular Therapy : an Official Journal of the International Society of Endovascular Specialists·Robert G MolnarUNKNOWN ACTIVE Trial Investigators
Aug 21, 2016·Journal of Vascular and Interventional Radiology : JVIR·Mark W BurketMichael R Jaff
Mar 30, 2017·Journal of Endovascular Therapy : an Official Journal of the International Society of Endovascular Specialists·John H RundbackPeter L Faries
Oct 14, 2010·Journal of Endovascular Therapy : an Official Journal of the International Society of Endovascular Specialists·Luc StockxUNKNOWN MELODIE Investigators

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