Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
340 participants
INTERVENTIONAL
2019-10-04
2022-05-12
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
RECO Flow Restoration Device Versus Solitaire FR With the Intention for Thrombectomy Study
NCT01983644
Combined Thrombectomy for Distal MediUm Vessel Occlusion StroKe
NCT05983757
Pragmatic Ischaemic Stroke Thrombectomy Evaluation
NCT01745692
Endovascular Therapy for Large Core Patients With Uncertain Response to Thrombectomy
NCT06961487
Proximal Internal Carotid Artery Acute Stroke Secondary to Tandem or Local Occlusion Thrombectomy Trial
NCT05611242
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
pRESET Thrombectomy Device
Mechanical Thrombectomy using the pRESET Thrombectomy Device
Mechanical Thrombectomy using the pRESET Thrombectomy device
Clot removal using the pRESET Thrombectomy device
Solitaire Revascularization Device
Mechanical Thrombectomy using the Solitaire Revascularization Device
Mechanical Thrombectomy using the Solitaire Revascularization Device
Clot removal using the Solitaire Revascularization Device
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Mechanical Thrombectomy using the pRESET Thrombectomy device
Clot removal using the pRESET Thrombectomy device
Mechanical Thrombectomy using the Solitaire Revascularization Device
Clot removal using the Solitaire Revascularization Device
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Clinical signs consistent with acute ischemic stroke
3. Subject is able to be treated within 8 hours of stroke symptom onset and within 1.5 hours (90 min) from screening CT / MRI to groin puncture.
4. Pre-stroke modified Rankin Score of 0 or 1
5. NIHSS ≥6 at the time of enrolment
6. If tPA is indicated, initiation of IV tPA should be administered as soon as possible and no later than 3.0 hours of onset of stroke symptoms (onset time is defined as the last time when the patient was witnessed to be at baseline neurologic status), with investigator verification that the subject has received/is receiving the correct IV tPA dose (0.9mg/kg) for the estimated weight.
7. Expanded Thrombolysis in Cerebral Infarction (eTICI) 0-1 flow confirmed by angiography that is accessible to the mechanical thrombectomy device in the following locations:
1. Intracranial internal carotid
2. M1 and/or M2 segment of the MCA
3. Carotid terminus
4. Vertebral artery
5. Basilar artery
Note: M1 segment of the MCA is defined as the arterial trunk from its origin at the ICA to the first bifurcation or trifurcation into major branches neglecting the small temporo-polar branch.
8. Imaging scores as follows:
· ASPECTS score must be 6-10 on NCCT or DWI-MRI.
If automated core volume assessment software is used:
* MR diffusion-weighted imaging (DWI) ≤50cc
* Computed tomography perfusion (CTP) core ≤50 cc
9. Subject is willing to conduct protocol-required follow-up visits.
10. A valid completed informed consent by participant or LAR (Legally Authorized Representative)
Exclusion Criteria
2. Female who is pregnant or lactating or has a positive pregnancy test at time of admission.
3. Rapid neurological improvement prior to study enrolment suggesting resolution of signs/symptoms of stroke
4. Known serious sensitivity to radiographic contrast agents
5. Known sensitivity to nickel, titanium metals, or their alloys
6. Subjects already enrolled in other investigational studies that would interfere with study endpoints
7. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency. (A subject without history or suspicion of coagulopathy does not require INR or prothrombin time lab results to be available prior to enrolment.)
8. Known renal failure as defined by a serum creatinine \> 2.0 mg/dl (or 176.8 μmol/l) or glomerular filtration rate (GFR) \< 30.
9. Subject who requires hemodialysis or peritoneal dialysis, or who has a contraindication to an angiogram for whatever reason.
10. Life expectancy of less than 90 days
11. Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT or MRI scan is normal
12. Suspicion of aortic dissection
13. Subject with a comorbid disease or condition that would confound the neurological and functional evaluations or compromise survival or ability to complete follow-up assessments.
14. Subject is known to currently use or has a recent history of illicit drug(s) or abuses alcohol (defined as regular or daily consumption of more than four alcoholic drinks per day).
15. Known arterial condition (e.g., proximal vessel stenosis or pre-existing stent) that would prevent the device from reaching the target vessel and/or preclude safe recovery of the device
16. Subject who requires balloon angioplasty or stenting of the carotid artery at the time of the index procedure
17. Angiographic evidence of carotid dissection
18. CT or MRI evidence of hemorrhage on presentation
19. CT or MRI evidence of mass effect or intra-cranial tumor (except small meningioma)
20. CT or MRI evidence of cerebral vasculitis
21. CT or MRI-DWI showing ASPECTS 0-5. Alternatively, if automated core volume assessment software is used, MRI-DWI or CTP core \> 50cc.
22. CT/MRI shows evidence of carotid dissection or complete cervical carotid occlusion requiring a stent
23. Any imaging evidence that suggests, in the opinion of the investigator, the subject is not appropriate for mechanical thrombectomy intervention (e.g. inability to navigate to target lesion, moderate/large infarct with poor collateral circulation, etc.).
24. Occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation) as confirmed by angiography, or clinical evidence of bilateral strokes or strokes in multiple territories
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
phenox Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Raul G Nogueira, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh Medical Center, Pittsburgh
Richardo A Hanel, MD
Role: PRINCIPAL_INVESTIGATOR
Baptist Medical Center Jacksonville
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Honor Health Research Institute
Scottsdale, Arizona, United States
Providence Little Company of Mary Medical Center
Santa Monica, California, United States
University of Miami
Coral Gables, Florida, United States
Baptist Health Research Institute Jacksonville
Jacksonville, Florida, United States
Grady Memorial Hospital
Atlanta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Advocate Lutheran General Hospital
Downers Grove, Illinois, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of Massachusetts
Worcester, Massachusetts, United States
JFK Medical Center
Edison, New Jersey, United States
Buffalo General Medical Center
Buffalo, New York, United States
NYU Langone Health
New York, New York, United States
The Mount Sinai Hosptial
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
OhioHealth Research Institute
Columbus, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
UPMC
Pittsburgh, Pennsylvania, United States
Valley Baptist
Harlingen, Texas, United States
Swedish Medical Center - Cherry Hill Campus
Seattle, Washington, United States
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
Klinikum rechts der Isar Technische Universität München
München, Bavaria, Germany
Klinikum Bremen-Mitte
Bremen, Lower Saxony, Germany
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Lübeck, Schleswig-Holstein, Germany
Helios Klinikum Erfurt GmbH
Erfurt, Thuringia, Germany
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
pCT-001-19
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.