Acute ischemic stroke studies

  • Individual patient level meta-analysis: United States   
  • Provide an individual level, single imaging core lab evaluated pooled analysis to provide a more accurate treatment effect estimation and subgroup analysis of mechanical thrombectomy performed with modern thrombectomy devices compared to best medical therapy using all available randomized data in patients randomized beyond 6 hours from time last seen well.  
  • Evaluation of 490 patients from 5 trials   
  • Sponsor: University of Pittsburgh Medical Center   
  • PI: Dr. Tudor Jovin, MD, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania   
  • Status: Active
  • Prospective, single-center: France
  • Assess performance of the Catalyst 6 by extraction of the thrombus by aspiration in patients presenting with acute ischemic stroke
  • Up to 60 subjects at 1 site
  • Device: AXS Catalyst® 6 Distal Access Catheter
  • Sponsor: Centre Hospitalier Regional Universitaire de Lille
  • Contact: Laurent Estrade, MD – laurentestrade@gmail.com
  • PI: Laurent Estrade, MD, Centre Hospitalier Régional Universitaire de Lille
  • Status: Complete
  • Prospective, observational, multi-center, two-arm: United States
  • Evaluate if a favorable capillary index score and successful recanalization leads to successful outcomes
  • Up to 60 subjects at 5 sites
  • Devices: Trevo® Retriever and other thrombectomy products
  • ClinicalTrials.gov identifier: NCT02618031
  • Sponsor: Akron General Medical Center
  • Contact: Jackie Tomer – Jackie.Tomer@akrongeneral.org
    John Elias, PhD – john.elias@akrongeneral.org
  • PI: Firas Al-Ali, MD, Akron General Medical Center, Akron, OH
  • Status: Active, enrolling
     
  • Prospective single center: United States
  • Analyze clot composition to help understand how to approach case variables associated with clot type
  • Up to 50 subjects at 2 sites
  • Sponsor: Baylor College of Medicine
  • Contact: Melyssa Fink – melyssa.fink@bcm.edu
  • PI: Peter Kan, MD, Baylor College of Medicine, Houston, TX
  • Status: Enrollment complete. 
  • Retrospective single-center: France
  • Demonstrate a differential protein signature exists between atherothrombotic and cardiac-originated thrombi
  • 60 subjects at 1 site
  • Sponsor: Gui de Chauliac University Hospital
  • Contact: Prof. Vincent Costalat, V-costalat@chu-montpellier.fr
  • PI: Prof. Vincent Costalat, Gui de Chauliac University Hospital, Montpellier, France
  • Status: Active, enrolling
  • Prospective, single-center: Spain
  • Determine the safety of a novel selection approach measured by the rate in symptomatic intracranial hemorrhage on 24 hours CT scan
  • Compare the impact of different time metrics with in-hospital controls
  • Up to 200 patients at 1 site
  • Sponsor: Fundació de Recerca Hospital Vall d’Hebron
  • PI: Marc Ribo, MD, Vall d’Hebron
    Alejandro Tomasello, MD, Vall d’Hebron
  • Status: Active, enrolling
  • Single-center, observational, retrospective: United States
  • Report the speed (groin to recanalization), number of passes, recanalization and ENTs compared to other published techniques, such as direct aspiration
  • Up to 60 subjects at 1 site
  • Devices: FlowGate Balloon Guide Catheter, Trevo® Retriever
  • Sponsor: Banner Health
  • Contact: Mohamed S. Teleb, MD – Mohamed.teleb@bannerhealth.com
  • PI: Mohamed S. Teleb, MD, Banner Health, Mesa, AZ
  • Status: Active, enrolling complete
  • Prospective, randomized, single-center: United States
  • Evaluate sedation without paralytics vs. sedation with paralytics.
  • Up to 40 subjects at 1 site
  • Devices: Trevo® Retriever and other thrombectomy products
  • ClinicalTrials.gov identifier: NCT03036631
  • Sponsor: National Skull Base Center
  • Contact: Sajid Suriya – sajid.suriya@gmail.com
  • PI: M. Asif Taqi, MD, FAHA, National Skull Base Center, Thousand Oaks, CA
  • Status:  Active, enrolling
     
  • Prospective, multi-center: Netherlands
  • Randomized direct IAT vs IV-tPA with rescue IAT
  • Up to 540 subjects
  • Sponsor: AMC (Academic Medical Center Amsterdam), Netherlands
  • PI: Prof. Diederik W.J. Dippel, Prof. Aad van der Lugt, Prof. Yvo B. Roos and Prof. Charles B. Majoie, Academic Medical Center Amsterdam, Netherlands
  • Status: Active, enrolling
  • Prospective, single-center: Canada
  • Determine if the imaging selection criteria we are using with whole-brain CT perfusion is accurate for depicting unsalvageable tissue
  • 40 subjects at 1 site
  • ClinicalTrials.gov Identifier: NCT02988492
  • Sponsor: Ottawa Hospital Research Institute
  • Contact: Nicole Mikhael – nimikhael@ohri.ca
  • PI: Daniela Iancu, MD, The Ottawa Hospital Civic Campus, Ottawa, ON, Canada
  • Status: Active, enrolling
  • Prospective, multi-center: Germany
  • Acquire imaging, clinical variables and treatment costs of endovascular therapy for AIS patients with LVO in an effort to evaluate and compare clinical outcomes based on three different real-world treatment scenarios.
  • Up to 200 subjects at 2 sites
  • Sponsor: Heidelberg University Hospital (Universitätsklinikum Heidelberg)
  • PI: Martin Bendszus, MD, University of Heidelberg, Heidelberg, Germany; Jens Fiehler, PhD, University Medical Center Hamburg-Eppenddorf, Hamburg, Germany
  • Status: Active, enrolling 
  • Prospective, observational, multi-center: United States
  • Determine how different methods of interventional service delivery, specifically a mobile interventional stroke team, affect treatment times and outcomes in the Mount Sinai Health System.
  • Up to 300 subjects at 4 sites
  • Devices: Trevo® Retriever, other approved thrombectomy devices
  • ClinicalTrials.gov identifier: NCT03048292
  • Sponsor: Mount Sinai Health System
  • Contact: Ashley Friend - ashley.friend@mountsinai.org
  • PI: Johanna T. Fifi, MD, Icahn School of Medicine at Mount Sinai, New York, NY
  • Status: Active, enrolling
  • Cross-sectional, multi-center: United States
  • Determine the prevalence of ischemic strokes caused by large vessel occlusions among patients transported with a suspected acute stroke.
  • 2,402 subjects at 7 sites
  • Sponsor: Carolinas HealthCare Foundation
  • Contact: Nicol Brandon – nicol.brandon@carolinashealthcare.org
  • PI: Andrew Asimos, MD, Carolinas Medical Center, Charlotte, NC
  • Status: Complete. Publication accepted to Stroke. 
  • Prospective, multi-center: United States
  • To estimate overall treatment benefit (improvement in disability) among acute ischemic stroke patients that are randomized to general anesthesia compared with sedation during endovascular therapy
  • Up to 260 subjects at 10-15 sites
  • ClinicalTrials.Gov Identifier: NCT03263117
  • Sponsor: McGovern Medical School – UT Health Houston
  • Contact: Aditya Sanzgiri – Aditya.A.Sanzgiri@uth.tmc.edu
  • PI: Peng Roc Chen, MD, FACS, McGovern Medical School – UT Health Houston, Houston, Texas
  • Status: Active, enrolling
  • Prospective, non-randomized, two arms (mechanical thrombectomy and medical management), multi-center: United States
  • Evaluate different selection methodologies for endovascular therapy to identify which method provides highest predictive ability in the selection of patients for intra-arterial thrombectomy
  • Up to 500 subjects at 9 sites
  • Devices: Trevo® Retriever and other thrombectomy products
  • ClinicalTrials.gov identifier: NCT02446587
  • Sponsor: University of Texas Health Science Center
  • Contact: Bita Imam - bita.imam@uth.tmc.edu
  • PI: A. Sarraj, MD, The University of Texas Health Science Center, Houston, TX
  • Status: Active, enrolling
  • Prospective, multi-center: Germany
  • Improvement of acute stroke care by means of a binding stroke team algorithm and simulation-based stroke team training.
  • Up to 750 patients at 7 sites
  • Sponsor: Frankfurt University Hosptial
  • Contact: Heike Rai - heike.rai@kgu.de
  • PI: Waltraud Pfeilschifter, MD, University Hospital Frankfurt
  • Status: Active, enrolling
  • Retrospective, multi-center: United States
  • Report US post-market data on safety and efficacy of Trevo® Retriever in clinical practice and compare results to those obtained from Solitaire with the SWIFT, TREVO 2, and NASA studies
  • Over 600 patients at 23 sites
  • Sponsor: Mercy Health-St. Vincent Medical Center
  • Contact: Alicia Castonguay, PhD – aliciacastonguay@hotmail.com
  • PI: Osama Zaidat, MD
  • Status: Complete
  • Retrospective, non-randomized, multi-center: United States
  • Evaluate ability and time to retain arterial recanalization in affected vessel, number of passes required to achieve recanalization, and occurrence of distal emboli
  • Up to 130 subjects at 8 sites
  • Devices: Trevo® XP ProVue Retriever, AXS Catalyst® 6 Distal Access Catheter, FlowGate2™ Balloon Guide Catheter
  • ClinicalTrials.gov identifier: TBD
  • Sponsor: University of Massachusetts
  • Contact: Mary Howk, MS – Mary.Howk@umassmed.edu
  • PI: Ajit S. Puri, MD, University of Massachusetts, Worcester, MA
  • Status: Active
  • Interactive, randomized, multi-center: United States and international
  • Evaluate factors that influence medical decisions regarding EVT
  • Up to 600 subjects
  • Sponsor: University of Calgary
  • Contact: Mayank Goyal – mgoyal@ucalgary.ca
  • PI: Mayank Goyal, MD, University of Calgary, Calgary, Alberta, Canada
  • Status: Active

Hemorrhagic stroke studies

  • Prospective, randomized, multi-center: United States
  • Intracranial aneurysms
  • Evaluate occlusion rates with larger diameter coils (GDC® - 18 Detachable Coil) vs. standard diameter coil (Target® 360 Detachable Coil and GDC-10 Detachable Coil) at 12-18 months
  • Up to 660 subjects at 23 sites
  • Devices: Target and GDC Detachable Coils
  • ClinicalTrials.gov identifier: NCT01655784
  • Sponsor: Vanderbilt University
  • Contact: Stephanie A. Smith, MY, CCRP – Stephanie.anne.smith@vanderbilt.edu
  • PI: M. Froehler, MD, PhD, Vanderbilt University, Nashville, TN
  • National PI: J. Mocco, MD, MS, Mount Sinai, New York, NY
  • Status: Active, enrolling
  • Prospective, non-inferior, observational, single-arm, multi-center, post-approval: United States
  • Intracranial aneurysms reported rates for aneurysms 4mm or less in size at 18 months
  • Evaluate procedural failure of treating small aneurysms with Target Nano Detachable Coils against historically reported rates for larger aneurysms at 18 months
  • Up to 252 subjects at 20 sites
  • Device: Target® Coils
  • ClinicalTrials.gov identifier: NCT02167997
  • Sponsor: University of Virginia
  • Contact: Claire L. McKinley, CCRP – cw9ne@virginia.edu
  • PI: A.J. Evans, MD, University of Virginia, Charlottesville, VA
  • Status: Active, enrolling
  • Prospective, single-arm, single-center: United States
  • Intracranial saccular aneurysms (4-20mm)
  • Evaluate packing density of first coil and total coils
  • Up to 25 subjects at 1 site
  • ClinicalTrials.gov identifier: NCT02292017
  • Sponsor: Tennessee Neurovascular Institute, LLC
  • Contact: Carla Staruk, RN – cjackso3@covhlth.com
  • PI: K. Woodward, MD, Tennessee Neurovascular Institute, Knoxville, TN
  • Status: Active, enrolling
  • Retrospective single-center: United States
  • Determine rate of post-procedural thromboembolic complications to show very low DWI event rate in Neuroform cases.
  • 60 subjects at 1 site
  • Device: Neuroform stent
  • Sponsor: Tufts Medical Center, Boston, MA
  • PI: Adel Malek, MD, PhD, Tufts Medical Center, Boston, MA
  • Status: Complete 
  • Prospective single center: Netherlands
  • Compare accuracy of subtraction CT angiography and digital subtraction angiography in terms of visualization of the degree of occlusion of the aneurysm after Surpass Flow Diverter implantation
  • Up to 30 subjects at 1 site
  • Devices: Surpass Flow Diverter
  • Sponsor: Radboud University Medical Center, Nijmegen, Netherlands
  • PI: Joost de Vries, MD, Radboud University Medical Center, Nijmegen, Netherlands
  • Status: Active, enrolling 
  • Prospective, single-arm, multi-center, post-approval: United States
  • Intracranial saccular aneurysms
  • Evaluate the use of second-generation Stryker Target Nano Coils in the treatment of ruptured and unruptured intracranial aneurysms in real clinical practice
  • Up to 150 subjects at 16 sites
  • Device: Target Coils
  • ClinicalTrials.gov identifier: NCT01748903
  • Sponsor: Mercy St. Vincent
  • Contact: Victoria Calderon – vcalderon@mercy.com
  • PI: O. Zaidat, MD, MS, Mercy St. Vincent, Toledo, OH
  • Status: Active, enrolling
  • Prospective, single-arm, multi-center, post-approval: United States
  • Intracranial saccular aneurysms
  • Evaluate packing density with Target 360 Detachable Coils and Target Helical Detachable Coils immediately post-procedure
  • Up to 150 subjects at 12 sites
  • Device: Target Coils
  • ClinicalTrials.gov identifier: NCT 01748903
  • Sponsor: Mercy St. Vincent
  • Contact: Victoria Calderon – vcalderon@mercy.com
  • PI: O. Zaidat, MD, MS, Mercy St. Vincent, Toledo, OH
  • Status: Active, enrollment complete
     
  • Prospective, single-arm, multi-center: United States
  • Intracranial aneurysms ≤ 5 mm
  • Evaluate occlusion rates and target aneurysm recurrence with Ultra Coils
  • Up to 100 subjects at 6 sites
  • Device: Target® Coils
  • Sponsor: University of Maryland School of Medicine
  • Contact: Ranyah Almardawi – RanyahAlmardawi@umm.edu
  • PI: G. Jindal, MD, University of Maryland School of Medicine, Baltimore, MD
  • Status: Active, enrolling
     

Intracranial atherosclerotic disease studies

  • Prospective, randomized, multi-center: China
  • Recent TIA or stroke caused by 70-90% stenosis of major intracranial artery
  • Best medical care plus stenting vs. best medical care
  • Ischemic stroke, death or cardiovascular event within 30 days or any revascularization procedure of treated lesion during follow-up or any stroke, or death in territory of symptomatic artery between 30 days to 1 year between groups
  • Up to 380 subjects at 8 sites
  • ClinicalTrials.gov identifier: NCT01763320
  • Sponsor: Xuanwu Hospital 
  • Contact: L. Jiao, MD – jiaoliqun@gmail.com
  • PI: L. Jiao, MD, Xuanwu Hospital, Capital Medical University, Beijing, China
  • Status: Complete
     
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