News | April 05, 2010

Trials Evaluate Small Vessel, Long Lesion Versions of Everolimus Stent

The Promus Element everolimus-eluting coronary stent.

April 5, 2010 – Patient enrollment was recently completed in the Small Vessel and Long Lesion trials of the PLATINUM clinical program. It is designed to compare the platinum chromium Promus Element Everolimus-Eluting Stent to matched historical control groups of patients treated with the Taxus Express2 Paclitaxel-Eluting Stent.

The Small Vessel trial enrolled 94 patients with de novo lesions greater than or equal to 2.25 to less than 2.5 mm in diameter and less than or equal to 28 mm in length. The Long Lesion trial enrolled 102 patients with de novo lesions greater than 24 to less than or equal to 34 mm in length, and greater than or equal to 2.5 to less than or equal to 4.25 mm in diameter. Both trials enrolled patients at more than 30 sites worldwide.

"Data from clinical studies have shown that small vessels and long lesions each represent an estimated 10 percent of percutaneous coronary interventions," said Gregg W. Stone, M.D., professor of medicine and the director of research and education at the Center for Interventional Vascular Therapy at the Columbia University/New York-Presbyterian Hospital. He is also principal investigator for the PLATINUM program. "The availability of everolimus-based small vessel and long lesion stents will allow physicians greater flexibility in treating a broad range of complex coronary lesions. We look forward to the results of these important trials."

PLATINUM is a pivotal, randomized, controlled clinical trial program designed to support U.S. Food and Drug Administration and Japanese Ministry of Health, Labor and Welfare approval of the Promus Element Stent. Boston Scientific received CE mark European approval for this product in Oct. 2009.

Another key trial is the PLATINUM Workhorse trial, which compares the Promus Element Stent to the Promus stent (the same as the Xience stent made by Abbott). The study completed enrollment of 1,531 patients at 133 sites worldwide in September 2009. Results are expected in early 2011.

For more information:

Related Content

Bivalirudin exhibited an improvement in 30-day all-cause mortality when injected post PCI.
News | Antiplatelet and Anticoagulation Therapies| August 16, 2017
August 16, 2017 — A study has examined the efficacies of various post-percutaneous coronary intervention (PCI) bivali
ESC 2017 late breaking trial hot line study presentations.
News | Clinical Study| August 16, 2017
Aug. 16, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking Clinic
News | Drug-Eluting Balloons| August 15, 2017
Surmodics Inc. announced receipt of an investigational device exemption (IDE) from the U.S. Food and Drug...
The Vascular Dynamics MobiusHD device enhances the carotid baroreceptors to reduce resistant hypertension.
News | Hypertension| August 15, 2017
Aug. 15, 2017 — The U.S. Food and Drug Administration (FDA) has approved the Vascular Dynamics Inc.
Abbott Initiates First Clinical Trial of Clip-Based Tricuspid Repair System
News | Heart Valve Technology| August 09, 2017
Abbott announced that the first patient has been enrolled in a clinical study to evaluate a minimally invasive clip-...
Three New Atrial Fibrillation Studies to Feature HeartLight Endoscopic Ablation System
News | Ablation Systems| August 07, 2017
CardioFocus Inc. announced that its HeartLight Endoscopic Ablation System is being featured in three new major clinical...
Registry Identifies Early Onset of Heart Failure and Lack of Defibrillators in Asia
News | Heart Failure| August 03, 2017
August 3, 2017 — The Asian Pacific Society of Cardiology (ASPC) held its first-ever late-breaking...
New Study Focuses on Protein Responsible For Increased Heart Disease Risk
News | Cardiac Diagnostics| August 03, 2017
August 3, 2017 — A study to reduce the strongest inherited...
Overlay Init