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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