Houston Methodist. Leading Medicine.
Houston Methodist. Leading Medicine

Eddy Scurlock Stroke Center

Contact Information

David McCane, CCRC
Research Manager
6560 Fannin, Suite 902
Houston, TX  77030

Phone: 713-441-5801
Fax: 713-793-7019
Email: dmccane@houstonmethodist.org

If you think you are having a stroke call 911

Clinical Trials

Exemplifying Houston Methodist’s longstanding leadership in clinical research, the Eddy Scurlock Stroke Center offers stroke patients a wide range of clinical research trials aimed at improving outcomes, survival and prevention of stroke recurrence.

 

Acute Stroke Trials

Eligibility for Acute Stroke Trials are determined in Houston Methodist Hospital Emergency Room.
Do not contact office for eligibility. 

ACTIVELY ENROLLING

-----IMPACT-24B  (IMPlant Augmenting Cerebral Blood Flow Trial 24 hours from stroke onset)-------

A Multicenter, Randomized, Double Blind, Sham Control, Parallel Arm Trial to Assess Safety and Effectiveness of the Ischemic Stroke System ISS, as an Adjunct to Standard of Care in Subjects with Acute Ischemic Stroke 24 hour post stroke window 

David Chiu, M.D. – Principal Investigator- Neurologist
John J. Volpi, M.D.- Sub-Investigator-Neurologist
Donald W. Bledsoe, RN, MSN, ANP-C Sub-Investigator-Neurology
Delmar Imperial-Aubin, RN, MSN, ACNP-C Sub Investigator-Neurology
Stacy Moye, RN, NP-C– Sub-Investigator-Neurology
David McCane, CCRC –Sub-Investigator-Research Coordinator
Larry Katz, P.hD. –Sub-Investigator- Research Coordinator
Study sponsor- BrainsGate Ltd.

-----MULTISTEM-----

Double-Blind, Randomized, Placebo-Controlled Phase 2 Safety and Efficacy Trial of MultiStem® in Adults With Ischemic Stroke  24-36 hour post stroke window 

David Chiu, M.D. – Principal Investigator- Neurologist
John J. Volpi, M.D.- Sub-Investigator-Neurologist
Donald W. Bledsoe, RN, MSN, ANP-C Sub-Investigator-Neurology
Delmar Imperial-Aubin, RN, MSN, ACNP-C - Sub Investigator-Neurology
Stacy Moye, RN, NP-C– Sub-Investigator-Neurology
David McCane, CCRC –Sub-Investigator-Research Coordinator
Larry Katz, P.hD. –Sub-Investigator- Research Coordinator
Study sponsor- Athersys Inc.

-----THERAPY Trial-----

The Randomized, Concurrent Controlled Trial to Assess the Penumbra System’s Safety and Effectiveness in the Treatment of Acute Stroke

David Chiu, M.D. – Principal Investigator- Neurologist
John J. Volpi, M.D.- Sub-Investigator-Neurologist
Donald W. Bledsoe, RN, MSN, ANP-C - Sub-Investigator-Neurology
Delmar Imperial-Aubin, RN, MSN, ACNP-C - Sub Investigator-Neurology
Stacy Moye, RN, NP-C– Sub-Investigator-Neurology
David McCane, CCRC –Sub-Investigator-Research Coordinator
Larry Katz, P.hD. –Sub-Investigator- Research Coordinator
Study sponsor- Penumbra Inc.

Secondary Stroke Prevention Trials

------- POINT Study -------

 Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke

David Chiu, M.D. - Principal Investigator- Neurologist
John J. Volpi, M.D. - Sub-Investigator-Neurologist
Donald W. Bledsoe, RN, MSN, ANP-C - Sub-Investigator-Neurology
Delmar Imperial-Aubin, RN, MSN, ACNP-C- Sub Investigator-Neurology
Stacy Moye, RN, NP-C- Sub Investigator-Neurology
David McCane, CCRCSub-Investigator, Research Coordinator
Study sponsor - National Institute of Health (NIH)

------- GORE REDUCE Study -------

The study objective is to demonstrate that patent foramen ovale (PFO) closure with the GORE HELEX Septal Occluder plus antiplatelet medical management is safe and effective and reduces the risk of recurrent stroke or imaging-confirmed transient ischemic attack (TIA) when compared to antiplatelet medical management alone in patients with a PFO and history of cryptogenic stroke or imaging-confirmed TIA.  Approximately 664 subjects will be randomized to either the test or control arm using a 2:1 randomization scheme. A maximum of fifty (50) Investigational Sites in the United States and Nordic Countries will participate in the study. 

John J. Volpi, M.D.- Principal Investigator-Neurologist
Neal Kleiman, M.D. - Sub-Investigator - Cardiologist
David Chiu, M.D. - Sub-Investigator - Neurologist
Donald W. Bledsoe, RN, MSN, ANP-C - Sub-Investigator-Neurology
Delmar Imperial-Aubin, RN, MSN, ACNP-C- Sub Investigator-Neurology
Melinda Tindal, RN, CCRP, CCRC - Research Coordinator
Study sponsor- W.L. Gore, Inc.

------- PREMIUM -------

Prospective Randomized investigation to Evaluate incidence of headache reduction in subjects with Migraine and PFO Using the AMPLATZER PFO Occluder compared to Medical Management. 
The objective of this study is to evaluate whether percutaneous PFO closure is effective in reducing the incidence of disabling migraine headaches in subjects who are not responding to medical treatment. This purpose will be evaluated by investigating whether subjects with percutaneous PFO closure experience a significant reduction in migraine headaches through a 12 month post-PFO closure in comparison to a sham group who will be receiving a sham procedure and standard of care therapy.  Approximately 232 subjects are needed for this study.

John J. Volpi, M.D.- Principal Investigator-Neurologist
Neal Kleiman, M.D. - Sub-Investigator - Cardiologist
David Chiu, M.D. - Sub-Investigator- Neurologist
Donald W. Bledsoe, RN, MSN, ANP-C Sub-Investigator-Neurology
Delmar Imperial-Aubin, RN, MSN, ACNP-C - Sub Investigator-Neurology
Melinda Tindel, CCRP - Research Coordinator
Study sponsor- AGA Medical Corporation

Ongoing Trials Enrollment Concluded

------- IRIS -------

Insulin Resistance Intervention after Stroke Trial 

David Chiu, M.D. - Principal Investigator- Neurologist
Ken Ling, M.D. - Research Coordinator
Study sponsor - National Institute of Health (NIH)
Trial Website - www.iristrial.org 

------- SAMMPRIS -------

Stenting  and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis

David Chiu, M.D. - Co-Principal Investigator- Neurologist
Richard Klucznik, M.D. Co-Principal Investigator- Interventional Neuroradiologist
John J. Volpi, M.D.- Sub-Investigator-Neurologist
Orlando Diaz, M.D. Sub-Investigator- Interventional Neuroradiologist
Donald W. Bledsoe, RN, MSN, ANP-C- Sub-Investigator-Neurology
Delmar Imperial-Aubin, RN, MSN, ACNP-C - Sub Investigator-Neurology
David McCane, CCRC - Research Coordinator
Study sponsor - National Institute of Health (NIH)
Trial Website - www.sammpris.org

------- CREST -------

Carotid Revascularization Endarterectomy vs. Stent Trial  The trial will assess the differential efficacy of carotid stenting and carotid endarterectomy in preventing stroke, myocardial infarction, and death in the peri-procedural period and ipsilateral stroke over the follow-up period.  

David Chiu, M.D. - Principal Investigator- Neurologist
Richard Klucznik, M.D. Co-Investigator- Interventional Neuroradiologist
Jimmy Howell, M.D. - Sub-Investigator- Vascular surgeon
George Noon, M.D. - Sub-Investigator- Vascular surgeon
Michael Reardon, M.D. - Sub-Investigator- Vascular surgeon
David McCane, CCRC - Research Coordinator
Study sponsor - National Institute of Health (NIH)
Trial Website www.cresttrial.org

Recently completed stroke trials

SPS3 -Secondary Prevention of Small Sub cortical Strokes trial 

NEST-3 -NeuroThera® Efficacy and Safety Trial - 3 (NEST-3) A double-blind, randomized, sham-controlled, parallel group, multicenter, pivotal study to assess the safety and efficacy of transcranial laser therapy with the NeuroThera® Laser System for the treatment of acute ischemic stroke within 24 hours of stroke onset

MACSI - A double blind, randomized, placebo-controlled, parallel group, multicenter Phase 3 pivotal study to assess the safety and efficacy of 1mg/kg/day intravenous DP-b99 over 4 consecutive days versus placebo when initiated within nine hours of acute ischemic stroke onset

DIAS-4 -This Phase III, study will assess efficacy and safety of Desmoteplase in treating acute, ischemic stroke patients within 9 hours from the onset of stroke symptoms. 320 patients will be enrolled across 80 centers. 

IMPACT-24-(IMPlant Augmenting Cerebral blood flow Trial 24 hours from stroke onset)-This Phase III, study will evaluate the safety and effectiveness of a new implantable neurostimulator device, called the Ischemic Stroke System (ISS), in the treatment of acute ischemic stroke within 24 hours from the onset of stroke symptoms.  60 patients will be enrolled across 6 centers in the U.S.-Study sponsor- BrainsGate Ltd.
 
ARISTOTLE: -A Phase 3, Active (Warfarin) Controlled, Randomized, Double-Blind, Parallel Arm Study to Evaluate Efficacy and Safety of Apixaban in Preventing Stroke and Systemic Embolism in Subjects with Nonvalvular Atrial Fibrillation-Study Sponsor- Bristol-Myers-Squibb, Inc.

MP-124-A01- This Phase I, first-in-human study will assess the safety, tolerability, and pharmacokinetics of ascending 24- and 72- hour, continuous infusions of various doses of the neuroprotectant MP-124 in acute, ischemic stroke patients within 6 hours from the onset of stroke symptoms. 72 patients will be enrolled across 23 centers.-Study sponsor- Mitsubishi Tanabe Pharma Corporation 

COSS - NS42167: Carotid Occlusion Surgery Study- This study will be determine whether surgical anastomosis of the superficial temporal artery to the middle cerebral artery (STA-MCA) combined with best medical therapy can reduce subsequent ipsilateral ischemic stroke (fatal and non-fatal) at two years by 40%, despite perioperative stroke and death. This hypothesis will be tested by conducting a randomized, non-blinded, controlled trial in 372 participants randomized equally to surgical or non-surgical treatment.-Study sponsor- University of North Carolina 

SENTIS- This phase III study will assess the safety and efficacy of the NeuroFlo Cerebral Perfusion Augmentation Catheter acute stroke therapy in subjects beginning treatment within 8 hours of the onset of acute ischemic stroke-Study sponsor - CoAxia 

CLOSURE I  - A prospective, multi-center, randomized controlled trial to evaluate the safety and efficacy of the STARFlex septal closure system versus best medical therapy in patients with stroke and/or transient ischemic attack due to presumed paradoxical embolism through a patent foramen ovale  (PFO)-Study sponsor - NMT Medical
 
TRA2P/TIMI-50  A multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SCH 530348 in Addition to Standard of Care in Subjects With a History of Atherosclerotic Disease: Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events (TRA2P-TIMI-50)- Study Sponsor: Schering-Plough Research Institute

NEST-2/NeuroThera®- Effectiveness and Safety Trial - 2.  A double blind, randomized, controlled, parallel group, muliticenter, pivotal study to assess the safety and effectiveness of the treatment of acute ischemic stroke with the NeuroTheraâ Laser System within 24 hours from stroke onset.-Study sponsor- PhotoThera 

TUCSON- A Phase 1-2, Randomized, Placebo-Controlled, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, and Activity of Ascending Single Doses of MRX-801 with Continuous Ultrasound Administration in Subjects with Acute Ischemic Stroke Receiving Treatment with Intravenous Tissue Plasminogen Activator.-Study sponsor- ImaRx Therapeu 

VASTT/Canadian Stroke Consortium- A Phase II, Multi-Centre, Two-Part Study to Evaluate the Safety and Efficacy of V10153 in Acute Ischaemic Stroke.  Part A - An Open Label, Dose Escalation, Single-Dose Administration Evaluation of the Safety of Four Dose Levels of V10153. Part B - A Randomised, Double-Blind, Placebo-Controlled, Evaluation of the Safety and Efficacy of a Single Dose of V10153.- Study sponsor- Vernalis 

ANCROD- A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Viprinex™ (Ancrod Injection) in Subjects Beginning Treatment within 6 Hours of the Onset of Acute, Ischemic Stroke.-Study sponsor- Neurological Technologies, Inc. 

DIAS-2- A Prospective, Randomized, Double-Blind, Placebo-Controlled, Single Bolus, Multinational, Multi-Center, Parallel Group, Dose-Ranging Study of Desmoteplase (INN) in the Indication of Acute Stroke..-Study sponsor - PAION/Forest Research Institute 

ALIAS- Albumin in Acute Stroke Trial: A Phase III Randomized Multicenter Clinical Trial of High-Dose Human Albumin Therapy for Neuroprotection in Acute Ischemic Stroke with treatment beginning within 5 hours of the onset of acute ischemic stroke.-Study sponsor - National Institute of Health (NIH)

EPIC- A Phase IIb Randomized, Double-Blind, Placebo-Controlled, Group-Sequential, Multicenter, Dose Finding Study of the Safety and Efficacy of SUN N4057 (Piclozotan) Administered for 72 Hours by Continuous Intravenous Infusion in Subjects with Acute Ischemic Stroke and Measurable Penumbra on MRI. -Study sponsor - Daiichi Asubio Pharmaceuticals, Inc. 

PREVAIL- A double-blind, randomized, parallel-group, multi-center, study to evaluate the efficacy and safety of Enoxaparin versus unfractionated Heparin in the prevention of venous thromboembolism in patients following acute ischemic stroke.- Study sponsor - Sanofi-Aventis Phamaceuticals 

RREACT   - Placebo controlled evaluation of neuroprotectant ONO-2506 intravenous infusion in subjects with acute ischemic stroke. -Study sponsor - ONO Pharmaceuticals 

CHANT/NXY-0012   - A double blind, randomized, placebo controlled, parallel group, multicenter, phase IIb study to assess the safety and tolerability of 72 hours intravenous infusion of NXY-059 in adult patients with intracerebral hemorrhage (ICH).-Study sponsor - AstraZeneca Pharmaceuticals 

SAINT II/NXY-0007- A double blind, randomized, placebo controlled, parallel group, multicenter, phase IIb/III study to assess the efficacy and safety of intravenous NXY-059 in acute ischemic stroke. -AstraZeneca Pharmaceuticals 

PROFESS- Prevention Regimen For Effectively avoiding Second Strokes:  A double-blind, active and placebo controlled study of Aggrenox vs. Clopidogrel + aspirin, with and without Micardis.-Study sponsor - Boehringer Ingelheim Pharmaceuticals, Inc. 

ONTARGET/TRANSCEND- ONTARGET- Ongoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial: A large simple randomized trial of an angiotension II receptor antagonist (Telmisartan) an ACE-Inhibitor (Ramipril) in patients at high risk for cardiovascular events.
Parallel study:  TRANSCEND- Telmisartin Randomized Assessment Study in ACE intolerant subjects with cardiovascular Disease  (enrollment ended) follow-up continues. -Study sponsor - Boehringer Ingelheim Pharmaceuticals, Inc. 

Additional information on Stroke Clinical Trials can be found at:
ClinicalTrials.gov - www.clinicaltrials.gov         
Stroke Center - www.strokecenter.org