PROST: pRESET for Occlusive Stroke Treatment

• Sponsor: phenox Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03994822
• Collaborator: (none)
• Enrollment: 340
• Locations: 24
• Arms: 2
• Actual Duration (Months): 31.2
• Patients Per Site: 14.2
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Brain Diseases; Cardiovascular Diseases; Central Nervous System Diseases; Cerebrovascular Disorders; Ischemia; Nervous System Diseases; Pathologic Processes; Stroke, Ischemic; Stroke, Acute; Vascular Diseases	Device: Mechanical Thrombectomy using the pRESET Thrombectomy device; Device: Mechanical Thrombectomy using the Solitaire Revascularization Device	N/A

Detailed 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

Study Design

• Study Type: Interventional
• Actual Enrollment: 340 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Prospective, multi-center randomizedProspective, multi-center randomized
• Masking: Single (Outcomes Assessor)
• Masking Description: The blinded assessor performs all study assessments during and after hospital discharge (i.e., 24 hours, Day 7/Discharge (whichever is earlier), and 30 and day 90 visits
• Primary Purpose: Treatment
• Official Title: pRESET for Occlusive Stroke Treatment
• Actual Study Start Date: Oct 4, 2019
• Actual Primary Completion Date: May 12, 2022
• Actual Study Completion Date: May 12, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: pRESET Thrombectomy Device Mechanical Thrombectomy using the pRESET Thrombectomy Device	Device: Mechanical Thrombectomy using the pRESET Thrombectomy device; Clot removal using the pRESET Thrombectomy device
Active Comparator: Solitaire Revascularization Device Mechanical Thrombectomy using the Solitaire Revascularization Device	Device: Mechanical Thrombectomy using the Solitaire Revascularization Device; Clot removal using the Solitaire Revascularization Device

Outcome Measures

Primary Outcome Measures

1. Primary Effectiveness Endpoint: Patients with a Modified Rankin Scale (mRS) </= 2 [90 (+/-15) days]

   Global disability assessed via the blinded evaluation of the proportion of patients with a Modified Rankin Scale (mRS) </= 2

2. Primary Safety Endpoint: Device- or procedure-related symptomatic intracerebral hemorrhage (sICH) [24 (-8/+12) hours]

   Proportion of subjects with device- or procedure-related symptomatic intracerebral hemorrhage (sICH)

Secondary Outcome Measures

1. Successful Revascularization measured using the expanded Thrombolysis in Cerebrovascular Infarction (eTICI) [During Index Procedure]

   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.

2. Successful Revascularization on first pass measured using the expanded Thrombolysis in Cerebrovascular Infarction (eTICI) [During Index Procedure]

   Proportion of patients with eTICI 2c or greater, following the first pass of the assigned study device

3. Overall mortality following the index stroke [90 (+/-15) days]

   Overall mortality following the index stroke

4. Distribution of mRS shift across the entire spectrum of disability [90 (+/-15) days]

   Distribution of mRS shift across the entire spectrum of disability

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

8. Intracranial internal carotid

9. M1 and/or M2 segment of the MCA

10. Carotid terminus

11. Vertebral artery

12. 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.

1. 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

1. Subject is willing to conduct protocol-required follow-up visits.

2. 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:

1. CT or MRI evidence of hemorrhage on presentation

2. CT or MRI evidence of mass effect or intra-cranial tumor (except small meningioma)

3. CT or MRI evidence of cerebral vasculitis

4. CT or MRI-DWI showing ASPECTS 0-5. Alternatively, if automated core volume assessment software is used, MRI-DWI or CTP core > 50cc.

5. CT/MRI shows evidence of carotid dissection or complete cervical carotid occlusion requiring a stent

6. 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.).

7. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Honor Health Research Institute	Scottsdale	Arizona	United States	85251
2	Providence Little Company of Mary Medical Center	Santa Monica	California	United States	90404
3	University of Miami	Coral Gables	Florida	United States	33146
4	Baptist Health Research Institute Jacksonville	Jacksonville	Florida	United States	32207
5	Grady Memorial Hospital	Atlanta	Georgia	United States	30322
6	Rush University Medical Center	Chicago	Illinois	United States	60612
7	Advocate Lutheran General Hospital	Downers Grove	Illinois	United States	60515
8	University of Iowa Hospitals and Clinics	Iowa City	Iowa	United States	52242
9	University of Massachusetts	Worcester	Massachusetts	United States	01655
10	JFK Medical Center	Edison	New Jersey	United States	08820
11	Montefiore Medical Center	Bronx	New York	United States	10467
12	Buffalo General Medical Center	Buffalo	New York	United States	14203
13	NYU Langone Health	New York	New York	United States	10016
14	The Mount Sinai Hosptial	New York	New York	United States	10029
15	OhioHealth Research Institute	Columbus	Ohio	United States	43214
16	Oregon Health & Science University	Portland	Oregon	United States	97239
17	UPMC	Pittsburgh	Pennsylvania	United States	15213
18	Valley Baptist	Harlingen	Texas	United States	78550
19	Swedish Medical Center - Cherry Hill Campus	Seattle	Washington	United States	98122
20	Universitätsklinikum Heidelberg	Heidelberg	Baden-Württemberg	Germany	69120
21	Klinikum rechts der Isar Technische Universität München	München	Bavaria	Germany	81675
22	Klinikum Bremen-Mitte	Bremen	Lower Saxony	Germany	28205
23	Universitätsklinikum Schleswig-Holstein, Campus Lübeck	Lübeck	Schleswig-Holstein	Germany	23562
24	Helios Klinikum Erfurt GmbH	Erfurt	Thuringia	Germany	99089

Sponsors and Collaborators

• phenox Inc.

Investigators

• Principal Investigator: Raul G Nogueira, MD, Grady Memorial Hospital
• Principal Investigator: Richardo A Hanel, MD, Baptist Medical Center Jacksonville

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: phenox Inc.
• ClinicalTrials.gov Identifier: NCT03994822
• Other Study ID Numbers: pCT-001-19
• First Posted: Jun 21, 2019
• Last Update Posted: Jun 13, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by phenox Inc.: Brain; Brain Clot; Brain Infarction; Cerebral Ischemia; Cerebrovascular Disorders; Ischemia; Ischemic; Ischemic Stroke; Mechanical Thrombectomy; Neurovascular Intervention; phenox; pRESET; pRESET Thrombectomy Device; Revascularization; Randomized Control; Solitaire; Stent Retriever; Stroke; Vascular Diseases
• Additional relevant MeSH terms: Stroke; Nervous System Diseases; Brain Diseases; Central Nervous System Diseases; Cerebrovascular Disorders; Ischemic Stroke; Cardiovascular Diseases; Vascular Diseases; Ischemia; Pathologic Processes

Study Results

No Results Posted as of Jun 13, 2022