Hospitals:

  • Good Samaritan Hospital San Jose
  • Regional Medical Center San Jose

Current Trials: Neurology

Penumbra 3D Trial. (Enrolling)

(A randomized, concurrent controlled trial to assess the safety and effectiveness of the Separator 3D as a component of the Penumbra System in the revascularization of large vessel occlusion in acute ischemic stroke)

Penumbra ACE Trial (enrolling)

(The primary objective of this study is to gather post market data on the Penumbra Coil 400 (PC 400) System in the acute treatment of intracranial and peripheral aneurysms)

SAMMPRIS Trial (following)

The primary aim of this study of patients with 70%-99% stenosis of a major intracranial artery (MCA, carotid, vertebral, basilar) and TIA or non-disabling stroke within 30 days prior to enrollment is to determine whether intensive medical therapy plus

intracranial angioplasty and stenting is superior to intensive medical therapy alone for preventing:  any stroke or death within 30 days after

study entry, or any stroke or death within 30 days of any revascularization procedure of the qualifying symptomatic intracranial artery done during follow-up or ischemic stroke in the territory of the symptomatic intracranial artery from day 31 after study entry to completion of follow-up

 

Current Trials: Oncology

EPOCH:  (application process)

The effectiveness and safety of TheraSphere will be evaluated in patients with colorectal cancer with metastases in the liver, who are scheduled to receive second line chemotherapy. All patients receive the standard of care chemotherapy with or without the addition of TheraSphere.

STOP HCC: (application process)

The safety and effectiveness of TheraSphere will be evaluated in patients with unresectable hepatocellular carcinoma in whom treatment with standard-of-care sorafenib is planned. All patients receive the standard-of-care sorafenib with or without the addition of TheraSphere.

 

Participated in:

TREVO 2 Trial 2011 (closed)

(Randomized, prospectively controlled, multi-center, open label, adaptive, non-inferiority IDE study of arterial revascularization in acute ischemic stroke patients

CREATE –PAS 2007- 2012 (closed)

(To confirm the safety and effectiveness of the PROTÉGÉ ®

GPS™ and PROTÉGÉ® RX Carotid Stent Systems and SpiderFXTM Embolic Protection Device when used in the treatment of common and/or internal carotid artery stenoses for subjects with a high risk for complications during endarterectomy)

PICS TRIAL   2009-2010   (closed)

(The Penumbra™ System is a new generation of neuro-embolectomy devices specifically designed to remove thrombus through aspiration and direct thrombus extraction. The System was recently launched for commercial use after receiving 510(k) clearance from the US FDA for an acute ischemic stroke revascularization indication)

MERCI Registry 2008-2010 (closed)

From 2003- 2007, the MERCI and Multi MERCI Trials collectively included 305 prospective large-vessel acute ischemic stroke patients. These two trials demonstrated not only the clinical utility of the Merci Retrieval System®, but the clinical benefits of mechanical embolectomy in large vessel stroke

KAVIAR TRIAL 2006-2009 (closed)

Patients with osteoporotic vertebral body compression fractures will be randomly assigned to treatment with balloon kyphoplasty or vertebroplasty. Over 2 years of follow-up, back pain, back function, quality of life, adverse events, subsequent fractures and cumulative healthcare costs will be compared.

SENTIS Trial 2007-2009 (closed)

The purpose of this study is to assess the safety and efficacy of the NeuroFlo™ catheter for use in patients with ischemic stroke. The NeuroFlo device is intended to increase blood flow to the brain and potentially reduce the damage caused by stroke.

If you have any questions about our research trials please contact:
Ursula Kelly-Tolley RN
Research Coordinator
408 918-0405