News | November 24, 2010

Trial Results Announced for Peripheral Drug-Eluting Stent

November 24, 2010 – Results for a trial comparing a drug-eluting stent to balloon angioplasty and bare metal stenting in treating restenosis after angioplasty were announced at the VEITHsymposium. The Zilver PTX drug-eluting stent met the trial's 12-month primary endpoints.

The stent has CE mark approval in Europe for the superficial femoral artery.

Michael Dake, professor of cardiothoracic surgery, Stanford University School of Medicine, said that 479 patients were enrolled at 56 institutions in the United States, Japan and Germany. Of those, 241 patients were randomized to the Zilver PTX group and 238 to the percutaneous transluminal angioplasty (PTA) group. Demographics and lesion characteristics were similar for the groups. Approximately half the PTA group experienced acute failure and underwent secondary randomization, assigning 59 and 61 patients to provisional stenting with Zilver BMS and Zilver PTX, respectively.

"The study results met the 12-month primary endpoint goals showing non-inferior EFS and superior patency for the Zilver PTX compared to PTA,” Dake said. “There was also significant clinical improvement with the Zilver PTX. Patients with de novo or artery re-narrowing, or restenosis, after angioplasty were randomized to PTA or Zilver PTX stent placement. PTA patients experiencing acute failure underwent secondary randomization to provisional stenting with Zilver BMS or Zilver PTX. Endpoints included event-free survival, stent integrity by radiographic core laboratory analysis, and primary patency by Duplex ultrasound core laboratory analysis.”

The results of this randomized, multicenter study support the safety and effectiveness of the stent.

For more information: www.VEITHpress.org

Related Content

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp
Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Cardiovascular Clinical Studies | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo
Lexington Begins HeartSentry Clinical Trial
News | Cardiovascular Clinical Studies | February 20, 2018
February 20, 2018 – Lexington Biosciences, Inc., a development-stage medical device company, announced the commenceme
Endologix Completes Patient Enrollment in the ELEVATE IDE Clinical Study
News | Cardiovascular Clinical Studies | February 06, 2018
February 6, 2018 – Endologix, a developer and marketer of treatments for aortic disorders, announced the completion o
12-Month Results from Veryan Medical's MIMICS-2 IDE Study Presented at LINC
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 – Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS
LimFlow Completes U.S. Feasibility Study Enrollment, Receives FDA Device Status
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 –  LimFlow SA, developer of minimally-inv
ESC 2017 late breaking trial hot line study presentations.
News | Cardiovascular Clinical Studies | September 12, 2017
September 12, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking C
U.K., NHS studies, weekend effect, hospital admission, atrial fibrillation, heart failure
News | Cardiovascular Clinical Studies | June 28, 2016
New research shows patients admitted to National Health Service (NHS) hospitals in the United Kingdom for atrial...
stroke risk
News | Cardiovascular Clinical Studies | August 28, 2015
Most people assume strokes only happen to octogenarians, but recent evidence suggests that survivors of childhood can
Overlay Init