News | October 30, 2014

Cardiovascular Systems Enrolls First Seven Patients in Japan for Coast Study

Study to assess safety and efficacy of new coronary micro crown to secure regulatory approval in United States and Japan

October 30, 2014 — Cardiovascular Systems Inc. announced that the first seven patients in Japan have been enrolled in its Coronary Orbital Atherectomy System Trial (COAST) study. Taking place in the United States and Japan, the study is designed to assess the safety and efficacy, as well as economic outcomes, of CSI’s new micro crown Orbital Atherectomy System (OAS) in treating severely calcified coronary lesions in patients suffering from coronary artery disease (CAD). Shigeru Saito, M.D., director of cardiology and catheterization laboratories, Shonan Kamakura General Hospital, Kamakura, Japan, performed the procedures on Oct. 27.

The 1.25-mm micro crown is CSI’s second-generation system designed to facilitate stent delivery in patients with severely calcified lesions who are acceptable candidates for percutaneous transluminal coronary angioplasty (PTCA) or stenting. The micro crown OAS is designed to improve the tracking and piloting of the OAS driveshaft and the ability of the crown to reach the lesion while operating at lower rotational speeds.

“We’re excited to be in CSI’s pivotal COAST study,” said Saito. “Today, I used the company’s new micro crown OAS to successfully modify calcified coronary lesions in seven patients. Prepping the vessels with CSI’s technology enabled stent delivery and expansion in these challenging patient cases.”

Building on CSI’s ORBIT II study—the first study designed to enroll patients with severely calcified lesions who are typically excluded from all major trials but commonly seen in the real world—COAST is a prospective, single-arm, multi-center, global investigational study designed to evaluate the safety and efficacy of CSI’s new micro crown OAS in treating these difficult lesions.

Up to 100 subjects may be enrolled at up to 15 U.S. sites and five sites in Japan. Enrollment in the United States began in June 2014. Gregg Stone, M.D., director of the Cardiovascular Research and Education Center for Interventional Vascular Therapy at Columbia University Medical Center, New York, and Saito are the study’s principal co-investigators.

For more information: www.csi360.com

Related Content

Biotronik Studies Demonstrate Efficacy of Minimizing Metal Burden in SFA Therapy
News | Stents Bare Metal| September 22, 2017
Physicians demonstrated that reducing metal burden in superficial femoral artery (SFA) therapy could effectively reduce...
Edwards Inspiris Resilia Valve Receives FDA Approval
News | Heart Valve Technology| September 21, 2017
Edwards Lifesciences Corp. recently received U.S. Food and Drug Administration (FDA) approval for its Inspiris Resilia...
MyoKardia Presents Additional Positive Data From Phase 2 PIONEER-HCM Study at HFSA 2017
News | Heart Failure| September 21, 2017
MyoKardia Inc. announced that additional positive data from the first patient cohort of its Phase 2 PIONEER-HCM study...
Lesion Preparation Via Atherectomy Enhances Paclitaxel Distribution in Calcified Peripheral Arteries
News | Peripheral Artery Disease (PAD)| September 20, 2017
September 20, 2017 — Not-for-profit preclinical research institute CBSET announced that its scientists have published
DISRUPT BTK Study Shows Positive Results With Lithoplasty in Calcified Lesions Below the Knee
News | Peripheral Artery Disease (PAD)| September 20, 2017
Shockwave Medical reported positive results from the DISRUPT BTK Study, which were presented at the annual...
Corindus Announces First Patient Enrolled in PRECISION GRX Registry
News | Robotic Systems| September 18, 2017
September 18, 2017 — Corindus Vascular Robotics Inc.
Two-Year ILLUMENATE Trial Data Demonstrate Efficacy of Stellarex Drug-Coated Balloon
News | Drug-Eluting Balloons| September 18, 2017
Philips announced the two-year results from the ILLUMENATE European randomized clinical trial (EU RCT) demonstrating...
Sentinel Cerebral Protection System Significantly Reduces Stroke and Mortality in TAVR
News | Embolic Protection Devices| September 18, 2017
September 18, 2017 – Claret Medical announced publication of a new study in the...
Marijuana Associated With Three-Fold Risk of Death From Hypertension
News | Hypertension| September 14, 2017
Marijuana use is associated with a three-fold risk of death from hypertension, according to research published recently...
Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Feature | Cath Lab| September 14, 2017
September 14, 2017 — Here are quick summaries for all the key late-breaking vascular and endovascular clinical trials
Overlay Init