Clinical Studies for Radiology

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Title: RAPID-PE Study: RESCUE Advanced Protocol without ICU stay and no lytic Drip - for the Treatment of Pulmonary Embolism
Brief Title: RAPID-PE Study
Brief Summary: To demonstrate the efficacy and safety of the 8F BASHIR™ .035 Endovascular Catheter and the 8F BASHIR™ S-B .035 Endovascular Catheter for the administration of pharmaco-mechanical catheter directed therapy using pulse sprays of r-tPA into the pulmonary arteries for the treatment of intermediate risk pulmonary embolism (PE).
For info regarding 2024P000664 please contact Jeffrey Weinstein at 617-667-7000 or jlweinst@bidmc.harvard.edu
 
Title: PROTECTOR: Evaluating the Safety and Effectiveness of the Protrieve Sheath in Preventing Clinically Significant Intraprocedural Pulmonary Embolism by Providing Embolic Protection in the IVC During Thrombectomy Procedures to Treat DVT
Brief Title: PROTECTOR
Brief Summary: The Protrieve PROTECTOR Study is a prospective, single-arm, multicenter study of the Protrieve Sheath.
For info regarding 2024P000657 please contact Jeffrey Weinstein at 617-667-7000 or jlweinst@bidmc.harvard.edu
 
Title: A Safety and Feasibility Single-Arm Study of a Novel Catheter Thrombectomy Device For the Treatment of Pulmonary Embolism (ENGULF)
Brief Title: ENGULF
Brief Summary: Evaluation of initial safety and clinical feasibility of the Helo PE Thrombectomy System for thrombectomy in acute submassive pulmonary embolism (PE).
For info regarding 2023P000008 please contact Salomao Faintuch at 617-754-2523 or sfaintuc@bidmc.harvard.edu
 
Title: A Prospective, Multicenter, Single- Arm Post-Approval Study Investigating the Clinical Use and Safety of the Lutonix Drug Coated Balloon PTA Catheter for the Treatment of Dysfunctional AV Fistulae (Lutonix AV PAS)
Brief Title: Lutonix AV PAS
Brief Summary: This prospective, global, multicenter, single arm post-approval study is designed to investigate the clinical use and safety of the Lutonix® 035 AV Drug Coated Balloon (DCB) PTA Catheter in subjects presenting with clinical and hemodynamic abnormalities in native arteriovenous (AV) fistulae located in the upper extremity.
For info regarding 2022P000866 please contact Salomao Faintuch at 617-754-2523 or sfaintuc@bidmc.harvard.edu
 
Title: MRI Evaluation of Aging Related Changes to the Brain
Brief Title: MRI Evaluation of Aging Related Changes to the Brain
Brief Summary: The purpose of this study is to develop new magnetic resonance imaging (MRI) techniques that can be used to clinically evaluate patients across a spectrum of ages 18+. This study will test magnetic resonance techniques on FDA approved MRI machines. Newly developed MRI sequences will be validated on normal subject brains and compared to standard techniques. This study will evaluate different brain imaging techniques including Arterial Spin Labeling (ASL) perfusion and Inhomogeneous Magnetization Transfer (ihMT) imaging.
For info regarding 2017P000491 please contact David Alsop at 617-667-0275 or dalsop@bidmc.harvard.edu