pRESET for Occlusive Stroke Treatment

Cardiovascular Diseases Clinical Trial

— PROST  

Official title:

pRESET for Occlusive Stroke Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03994822
• Other study ID #: pCT-001-19
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Brain Diseases
• Cardiovascular Diseases
• Central Nervous System Diseases
• Cerebrovascular Disorders
• Ischemia
• Ischemic Stroke
• Nervous System Diseases
• Pathologic Processes
• Stroke
• Stroke, Acute
• Stroke, Ischemic
• Vascular Diseases

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