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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03994822
Other study ID # pCT-001-19
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 4, 2019
Est. completion date May 12, 2022

Study information

Verified date February 2022
Source phenox Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Compare the safety and effectiveness of pRESET to Solitaire in the treatment of stroke related to large vessel occlusion


Description:

To determine the safety and effectiveness of pRESET for the treatment of acute ischemic stroke within 8 hours of symptom onset (defined as time patient was last seen well) due to large vessel occlusion and to compare safety and effectiveness to the predicate device, Solitaire™ Platinum revascularization device


Recruitment information / eligibility

Status Completed
Enrollment 340
Est. completion date May 12, 2022
Est. primary completion date May 12, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Age >/=18 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: 1. Subject who has received IA-tPA prior to enrolment in the study 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 Imaging exclusion criteria: 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

Study Design


Intervention

Device:
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

Locations

Country Name City State
Germany Klinikum Bremen-Mitte Bremen Lower Saxony
Germany Helios Klinikum Erfurt GmbH Erfurt Thuringia
Germany Universitätsklinikum Heidelberg Heidelberg Baden-Württemberg
Germany Universitätsklinikum Schleswig-Holstein, Campus Lübeck Lübeck Schleswig-Holstein
Germany Klinikum rechts der Isar Technische Universität München München Bavaria
United States Grady Memorial Hospital Atlanta Georgia
United States Montefiore Medical Center Bronx New York
United States Buffalo General Medical Center Buffalo New York
United States Rush University Medical Center Chicago Illinois
United States OhioHealth Research Institute Columbus Ohio
United States University of Miami Coral Gables Florida
United States Advocate Lutheran General Hospital Downers Grove Illinois
United States JFK Medical Center Edison New Jersey
United States Valley Baptist Harlingen Texas
United States University of Iowa Hospitals and Clinics Iowa City Iowa
United States Baptist Health Research Institute Jacksonville Jacksonville Florida
United States NYU Langone Health New York New York
United States The Mount Sinai Hosptial New York New York
United States UPMC Pittsburgh Pennsylvania
United States Oregon Health & Science University Portland Oregon
United States Providence Little Company of Mary Medical Center Santa Monica California
United States Honor Health Research Institute Scottsdale Arizona
United States Swedish Medical Center - Cherry Hill Campus Seattle Washington
United States University of Massachusetts Worcester Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
phenox Inc.

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Primary Effectiveness Endpoint: Patients with a Modified Rankin Scale (mRS) </= 2 Global disability assessed via the blinded evaluation of the proportion of patients with a Modified Rankin Scale (mRS) 90 (+/-15) days
Primary Primary Safety Endpoint: Device- or procedure-related symptomatic intracerebral hemorrhage (sICH) Proportion of subjects with device- or procedure-related symptomatic intracerebral hemorrhage (sICH) 24 (-8/+12) hours
Secondary Successful Revascularization measured using the expanded Thrombolysis in Cerebrovascular Infarction (eTICI) Proportion of subjects with eTICI 2b50 or greater flow in the target vessel post procedure with 3 or fewer passes of the assigned study device. During Index Procedure
Secondary Successful Revascularization on first pass measured using the expanded Thrombolysis in Cerebrovascular Infarction (eTICI) Proportion of patients with eTICI 2c or greater, following the first pass of the assigned study device During Index Procedure
Secondary Overall mortality following the index stroke Overall mortality following the index stroke 90 (+/-15) days
Secondary Distribution of mRS shift across the entire spectrum of disability Distribution of mRS shift across the entire spectrum of disability 90 (+/-15) days
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