News | June 11, 2008

Cook's Drug-Eluting Peripheral Stent Shows Promising Preliminary Results

June 12, 2008 – The registry arm of a clinical study to assess the safety and effectiveness of Cook Medical’s Zilver PTX Drug-Eluting Peripheral Stent (DES) in treating peripheral arterial disease (PAD) has yielded positive interim results, trial investigators reported at the 2008 SVS Vascular Annual Meeting last week.

The findings, presented by Michael Dake, M.D., professor of Radiology, Internal Medicine and Surgery and chairman of the Department of Radiology at the University of Virginia Health System, reveal clinical improvement, excellent stent durability (i.e., fracture resistance), high rates of event-free survival (EFS) and freedom from target lesion revascularization (TLR). This preliminary information suggests no safety concerns, and promising effectiveness results.

“Cook's registry study and randomized trial are the first to use a paclitaxel-coated stent in the treatment of arterial blockages outside the heart,” said Dr. Dake, the trial’s global principal investigator. “They are designed to evaluate the safety and effectiveness of DES technology versus percutaneous transluminal angioplasty, and our initial findings in the registry arm give us every reason to believe that Zilver PTX may have the integrity, safety and durability needed to successfully address many of the well-known limitations of angioplasty alone for management of PAD.”

Interim data were compiled at six and 12 months for 435 patients and 200 patients respectively from the registry study, which enrolled a broad spectrum of patients, including those with complex lesions (e.g., long lesions, total occlusions, in-stent restenosis). The corresponding EFS rates were 94 percent and 84 percent, and freedom from TLR was 96 percent and 88 percent. Clinical measures that included ankle-brachial index, Rutherford score, and walking distance and speed scores showed significant improvement at six months and was maintained through 12 months.

Evaluation of stent x-rays is ongoing, and currently suggests stent fractures in only about one percent of cases at six months and less than two percent of cases at 12 months. Follow-up in the registry arm of the study will continue through two years.

“We are quite pleased with this first round of data from the registry portion of the study, and are optimistic we’ll encounter similar results throughout the duration of the Zilver PTX trial,” said Rob Lyles, global leader of Cook Medical's Peripheral Intervention products division. “At Cook, we are continually driving to improve the quality of our products and, in turn, improve the quality of patient outcomes. We are particularly excited about the potential benefits our self-expanding Zilver PTX stent provide can patients suffering from PAD.”

The clinical study is designed to evaluate the Zilver PTX in more than 1,000 patients across 89 trial sites in the United States, Asia, Latin America, Canada and Europe. In addition to the 790 DES patients enrolled in the registry arm of the study, approximately 240 of the 480 patients to be enrolled in the randomized arm of the study will receive the DES. Follow-up is ongoing for the registry, while enrollment in the randomized study is expected to be complete within the coming months.

For more information, visit and

Related Content

Resolute Onyx Stent With Improved Radiographic Visibility Found to Be Safe and Effective
News | Stents Drug Eluting | October 01, 2018
October 1, 2018 — Recent results from the BIONYX randomized clinical study showed the novel, thin-strutted, polymer-c
Boston Scientific Receives FDA Approval for Eluvia Drug-Eluting Vascular Stent
Technology | Stents Drug Eluting | October 01, 2018
Boston Scientific announced that the U.S. Food and Drug Administration (FDA) has approved its Premarket Approval (PMA)...
Eluvia Drug-Eluting Stent Demonstrates Superior Patency in IMPERIAL Trial
News | Stents Drug Eluting | September 26, 2018
Positive 12-month data from the late-breaking IMPERIAL trial was presented at the 2018 Transcatheter Cardiovascular...
Titanium-Nitride-Oxide Stent Superior to Bioabsorbable DES in Acute Coronary Syndrome Patients

Image courtesy of Hexacath

News | Stents Drug Eluting | May 31, 2018
Late-breaking trial results presented at the EuroPCR Congress, May 21-24 in Paris, France, found the Optimax titanium-...
Orsiro DES Shows Lowest Two-Year Target Lesion Failure in BIO-RESORT Trial
News | Stents Drug Eluting | May 31, 2018
Two-year outcome data from the BIO-RESORT randomized controlled trial were presented in a late-breaking clinical trials...
OCT Reveals Excellent Healing Profile for Complex CAD Patients With Resolute Onyx DES
News | Stents Drug Eluting | May 29, 2018
Investigators recently unveiled clinical data from the independently run Onyx 1-Month OCT Study showing strong early...
Abbott's Xience Sierra Stent Receives FDA Approval
Technology | Stents Drug Eluting | May 25, 2018
Abbott announced it received approval from the U.S. Food and Drug Administration (FDA) for Xience Sierra, the newest...
Medtronic Launches 2 mm Onyx DES
Technology | Stents Drug Eluting | February 26, 2018
February 26, 2018 – Designed specifically for small vessels, Medtronic plc announced U.S.
Detroit Medical Center Heart Hospital Uses Michigan's First EluNIR Drug-Eluting Stent
News | Stents Drug Eluting | February 19, 2018
February 19, 2018 — The Detroit Medical Center’s (DMC) interventional cardiology team at Heart Hospital recently beca
Biotronik Symposium Highlights Differing Roles of Drug-Eluting Stents and Magnesium Scaffolds in Clinical Practice
News | Stents Drug Eluting | January 25, 2018
January 25, 2018 – Data presented at the Biotronik-sponsored...
Overlay Init