Atrium Clinical Trials

Building a Bright Future in the Global Med-Tech Industry

Cardiology Clinical Research

Title:  INFUSE AMI
Principal Investigator(s):  Gregg Stone, MD – Columbia Presbyterian (New York, NY) and CO-PI Michael Gibson, MD – Beth Israel Deaconess Medical Center (Boston, MA)
Description:  A four-Arm, prospective, randomized, multicenter, single-blind evaluation of intracoronary (IC) Abciximab infusion via ClearWay™ RX and aspiration thrombectomy in patients undergoing percutaneous coronary intervention for anterior ST-segment elevation myocardial infarction (STEMI).
Primary Endpoint:  Reduced infarct size at 30 days measured by cardiac MRI

Title:  COCTAIL Study
Principal Investigator:  Francesco Prati, MD – Rome Heart Center (Rome, Italy)
Description:  A prospective, multi-center study examining the effects of localized intracoronary infusion of abciximab through the ClearWay RX catheter compared to localized infusion through a guide catheter. 
Primary Endpoint:  Reduction of thrombus burden measured by OCT

Title:  CRYSTAL MI
Principal Investigator:  Rajesh Dave, MD – Harrisburg Hospital (Harrisburg, PA)
Description: A randomized, single center, open-label evaluation of local intracoronary (IC) delivery of Abciximab via the ClearWay™ RX catheter versus standard intravenous (IV) delivery of Abciximab in patients with ST-segment elevation MI (STEMI).
Primary Endpoints:  Improvement in Myocardial Blush Grade (MBG), ST resolution, and Ejection Fraction

Title: IC ClearLY –
Principal Investigators:  Gennaro Sardella, MD, - Policlinico Umberto (Rome, Italy) and Michael Gibson, MD – Beth Israel Deaconess Medical Center (Boston, MA)
Description:  A randomized, open-label, multicenter, trial to evaluate the effect of an intracoronary (IC) bolus dose of Abciximab delivered using the ClearWay™RX catheter versus an intravenous (IV) bolus of Abciximab for ST-segment elevation myocardial infarction (STEMI) with angiographically visible thrombus. 
Primary Endpoint:  Reduction of infarct size measured by cardiac MRI

Title: ClearWay RX Registry
Principal Investigator:  Ron Waksman, MD - Washington Hospital Center (Washington, DC)
Description:  The primary goal of this registry is to collect clinical data regarding the use of the ClearWay™ RX Local Therapeutic Infusion Catheter for all coronary indications

Title:  VANTAGE 1
Principal Investigator:  John Ormiston, MD - Mercy Hospital and Auckland City Hospital (Auckland, NZ)
Description:  Non randomized, prospective, multi-center single arm trial, to assess the safety and efficacy of the Cinatra™ Drug Eluting Coronary Stent System for the treatment of single de novo lesions in native coronary arteries.
Primary Endpoint:  In-stent late lumen loss at 6 months post-procedure as measured by quantitative coronary angiography.

Title:  CONFIRM 1
Principal Investigator:  Glenn Van Langenhove, MD, PhD - Antwerp Cardiovascular Institute (Middelheim, Belgium)
Description:  A prospective, multicentre, single blind, randomized, clinical trial to assess the safety and efficacy of the Cinatra™ CoCr bare metal stent in patients with de novo coronary artery disease. The performance will be assessed by measuring the Late Lumen Loss, in-stent and in-segment at 6 months post procedure. Secondary end points include Target lesion revascularization (TLR), Target vessel revascularization (TVR), Stent thrombosis, Neointimal
Primary Endpoint:  Assess late lumen loss both in-stent and in-segment at 6 months

Peripheral Vascular Clinical Research

Title:  DELETE
Principal Investigator:  Nicolas Shammas, MD - Trinity Medical Center (Davenport, IA)
Description:  Single center prospective registry to evaluate the procedure success in restoring normal flow in limbs treated with the ClearWay RX with TPA in peripheral interventions.
Primary Endpoints:  Procedural success, thrombus resolution, ABI improvement

Title:  iCARUS
Principal Investigator:  John Laird, MD - U.C. Davis Medical Center (Sacramento, CA)
Description:  Prospective, multicenter, non-randomized, single arm study to evaluate the iCAST™ covered stent to a performance metrics derived from studies for the FDA-approved iliac stent devices for treating iliac artery stenoses in patients with de novo or restenotic lesions in the common and/or external iliac arteries.
Primary Endpoint:  Composite endpoint - Death within 30 days & target site revascularization (TVR) measured by ultrasound at 9 months

Title:  COBEST
Principal Investigator:  Patrice Mwipatayi, MD - Royal Perth Hospital (Perth, Australia)
Description:  A randomized, multi-center, trial to evaluate the performance of the Advanta™ V12 covered stent to bare metal balloon expandable stents in type B, C, and D aorto-iliac lesions. 
Primary Endpoint:  Comparison of primary & secondary patency

Aortic Clinical Research

Title:  Large Diameter Advanta™ V12 Covered Stent Trial for Coarctation of the Aorta
Principal Investigator:  Elchanan Bruckheimer, MD – Schneider Children’s Medical Center (Tikva, Israel)
Description:  A prospective, non-randomized, multi-center trial to evaluate the Advanta™ V12 Large Diameter covered stent for native or recurrent coarctation of the aorta.
Primary Endpoint:  Reduction in peak pressure gradient and improvement of area of coarctation

Vascular Access Clinical Research

Title: APHECS II
Principal Investigators:  A. Frederick Schild - MD University of Miami (Miami, FL) and Earl Schuman, MD - Good Samaritan Hospital (Portland, OR)
Description:  Prospective, non-randomized, multi-center trial assessing the performance of the FLIXENE vascular graft in patients that were cannulated in less than 72 hours.
Primary Endpoint:  Evaluate early cannulation potential