This FIH trial of a novel drug-coated scoring balloon will enroll 60 patients with coronary in-stent restenosis (ISR) at three renowned international sites, two in Germany and one in Brazil. The study will be led by Bruno Scheller, M.D., Professor of Interventional Cardiology at Saarland University Hospital, Homburg, Germany, who along with Professor Ulrich Speck of the Charite Hospital in Berlin, is one of the preeminent pioneers in the rapidly developing field of drug-coated balloons for the treatment of coronary and peripheral artery disease. "The development of a Drug-Coated AngioSculpt could represent a major advance in the percutaneous treatment of endovascular disease," said Professor Scheller. "I am honored to lead this important study and to collaborate with such an internationally prominent interventional cardiologist as Professor Alexandre Abizaid and his team at Dante Pazzanese Institute of Cardiology in Sao Paulo, Brazil."
"The AngioSculpt Scoring Balloon Catheter represents a significant improvement over conventional angioplasty balloon catheters for the treatment of challenging coronary and peripheral lesions because of its ability to achieve more predictable luminal expansion, avoid slippage or geographic miss and result in a lower rate of dissection. These features may be particularly valuable in the field of drug-coated balloons by ensuring more precise delivery of the anti-proliferative drug and potentially obviating the need to deploy a stent in a significant proportion of lesions," said Gary Gershony, M.D., Co-Founder and Chief Medical Officer of AngioScore. "Extensive pre-clinical studies performed by Professors Speck and Scheller have demonstrated the safety of a drug-coated AngioSculpt and its ability to have a profound effect on preventing restenosis. These studies have laid the groundwork for proceeding with a FIH clinical trial."
The drug-coated AngioSculpt FIH study is designed as a randomized controlled trial and will compare the recently developed drug-coated AngioSculpt with the commercially available uncoated version in patients presenting with significant restenosis in a previously implanted coronary bare metal stent. Patients will undergo follow-up coronary angiography at six months to compare the rate of recurrent restenosis and late lumen loss (LLL) in both treatment arms. Additional study endpoints include the rate of major adverse cardiovascular events (MACE), clinically driven target lesion revascularization (TLR) and stent thrombosis for up to two years following the index procedure. All angiograms will be analyzed by an independent core laboratory at the Cardiovascular Research Foundation in New York, N.Y.
Over three million coronary and peripheral angioplasty procedures are performed annually worldwide. A majority of these lesions are treated with permanent stents that often require concomitant treatment with a prolonged course of dual anti-platelet therapy to avoid the potentially life-threatening complication of stent thrombosis, adding significantly to the procedural costs and to the long-term risk of serious bleeding complications. Additionally, there are important lesion subsets which may not be suitable for stenting including diffusely diseased and smaller-caliber vessels, restenosed stents and certain peripheral vessels. A drug-coated AngioSculpt may allow a shortened course of dual anti-platelet therapy and has the potential to transform the treatment of many patients presenting with these challenging lesions.
The AngioSculpt Scoring Balloon Catheters represent the next generation in angioplasty catheters for both coronary and peripheral artery disease. Their innovative nitinol elements provide unique circumferential scoring of plaque, leading to precise and predictable luminal enlargement across a wide range of lesion types while avoiding "geographic miss" through their unique anti-slippage properties. The AngioSculpt catheters provide the versatility and effectiveness of a new technology together with the simplicity and deliverability of traditional high-performance balloon catheters.
AngioSculpt catheters have now been used in more than 100,000 procedures worldwide and have achieved an outstanding safety and performance record in the treatment of both coronary and peripheral artery disease.
The drug-coated AngioSculpt is currently investigational and not available for sale in the U.S. or Europe.
Posted by Sean Fenske, Editor-in-Chief, MDT