pRESET for Occlusive Stroke Treatment

NCT03994822 | Completed DMC FDA Device

• 1 other identifier: pCT-001-19
• Study Type: interventional
• Target: 340
• Locations: 2 countries
• Sites: 24

Brief Summary

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

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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) \</= 2

  90 (+/-15) days

• 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 Outcomes (4)

• Successful Revascularization measured using the expanded Thrombolysis in Cerebrovascular Infarction (eTICI)

  During Index Procedure

• Successful Revascularization on first pass measured using the expanded Thrombolysis in Cerebrovascular Infarction (eTICI)

  During Index Procedure

• Overall mortality following the index stroke

  90 (+/-15) days

• Distribution of mRS shift across the entire spectrum of disability

  90 (+/-15) days

Study Arms (2)

pRESET Thrombectomy Device

EXPERIMENTAL

Mechanical Thrombectomy using the pRESET Thrombectomy Device

Device: Mechanical Thrombectomy using the pRESET Thrombectomy device

Solitaire Revascularization Device

ACTIVE COMPARATOR

Mechanical Thrombectomy using the Solitaire Revascularization Device

Device: Mechanical Thrombectomy using the Solitaire Revascularization Device

Interventions

Mechanical Thrombectomy using the pRESET Thrombectomy device DEVICE

Clot removal using the pRESET Thrombectomy device

pRESET Thrombectomy Device

Mechanical Thrombectomy using the Solitaire Revascularization Device DEVICE

Clot removal using the Solitaire Revascularization Device

Solitaire Revascularization Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>/=18
• Clinical signs consistent with acute ischemic stroke
• 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.
• Pre-stroke modified Rankin Score of 0 or 1
• NIHSS ≥6 at the time of enrolment
• 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.
• Expanded Thrombolysis in Cerebral Infarction (eTICI) 0-1 flow confirmed by angiography that is accessible to the mechanical thrombectomy device in the following locations:
• Intracranial internal carotid
• M1 and/or M2 segment of the MCA
• Carotid terminus
• Vertebral artery
• 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.
• Imaging scores as follows:
• · ASPECTS score must be 6-10 on NCCT or DWI-MRI.

You may not qualify if:

• Subject who has received IA-tPA prior to enrolment in the study
• Female who is pregnant or lactating or has a positive pregnancy test at time of admission.
• Rapid neurological improvement prior to study enrolment suggesting resolution of signs/symptoms of stroke
• Known serious sensitivity to radiographic contrast agents
• Known sensitivity to nickel, titanium metals, or their alloys
• Subjects already enrolled in other investigational studies that would interfere with study endpoints
• 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.)
• Known renal failure as defined by a serum creatinine \> 2.0 mg/dl (or 176.8 μmol/l) or glomerular filtration rate (GFR) \< 30.
• Subject who requires hemodialysis or peritoneal dialysis, or who has a contraindication to an angiogram for whatever reason.
• Life expectancy of less than 90 days
• Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT or MRI scan is normal
• Suspicion of aortic dissection
• 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.
• 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).
• 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

Sponsors & Collaborators

• phenox Inc.: lead

Study Sites (24)

Honor Health Research Institute

Scottsdale, Arizona, 85251, United States

Location

Providence Little Company of Mary Medical Center

Santa Monica, California, 90404, United States

Location

University of Miami

Coral Gables, Florida, 33146, United States

Location

Baptist Health Research Institute Jacksonville

Jacksonville, Florida, 32207, United States

Location

Grady Memorial Hospital

Atlanta, Georgia, 30322, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Advocate Lutheran General Hospital

Downers Grove, Illinois, 60515, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

University of Massachusetts

Worcester, Massachusetts, 01655, United States

Location

JFK Medical Center

Edison, New Jersey, 08820, United States

Location

Buffalo General Medical Center

Buffalo, New York, 14203, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

The Mount Sinai Hosptial

New York, New York, 10029, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

OhioHealth Research Institute

Columbus, Ohio, 43214, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Valley Baptist

Harlingen, Texas, 78550, United States

Location

Swedish Medical Center - Cherry Hill Campus

Seattle, Washington, 98122, United States

Location

Universitätsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Klinikum rechts der Isar Technische Universität München

München, Bavaria, 81675, Germany

Location

Klinikum Bremen-Mitte

Bremen, Lower Saxony, 28205, Germany

Location

Universitätsklinikum Schleswig-Holstein, Campus Lübeck

Lübeck, Schleswig-Holstein, 23562, Germany

Location

Helios Klinikum Erfurt GmbH

Erfurt, Thuringia, 99089, Germany

Location

MeSH Terms

Conditions

Brain Diseases; Cardiovascular Diseases; Central Nervous System Diseases; Cerebrovascular Disorders; Ischemia; Nervous System Diseases; Pathologic Processes; Ischemic Stroke; Stroke; Vascular Diseases; Brain Infarction; Brain Ischemia

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms; Infarction; Necrosis

Study Officials

• Raul G Nogueira, MD

  University of Pittsburgh Medical Center, Pittsburgh

  PRINCIPAL INVESTIGATOR

• Richardo A Hanel, MD

  Baptist Medical Center Jacksonville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, multi-center randomized

Study Record Dates

• First Submitted: May 24, 2019
• First Posted: June 21, 2019
• Study Start: October 4, 2019
• Primary Completion: May 12, 2022
• Study Completion: May 12, 2022
• Last Updated: April 21, 2023

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (19); DE (5)