Clinical trial NCT02488915: Analysis of Revascularization in Ischemic Stroke With EmboTrap
Official title: ARISE II (Analysis of Revascularization in Ischemic Stroke With EmboTrap) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Ischemia
Keywords: Brain
Brain Clot
Brain Diseases
Brain Infarction
Cerebral Ischemia
Cerebrovascular Disorders
EmboTrap® Revascularization Device
EmboTrap
Ischemia
Ischemic
Ischemic Stroke
Mechanical Thrombectomy
Neurovascular Intervention
Revascularization
Stent Retriever
Stroke
Vascular Diseases
Neuravi
Lead sponsor: Neuravi Inc.
Sponsor class: INDUSTRY
First posted: 2015-07-02
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study objective is to examine the recanalization efficacy of the EmboTrap device and its associated performance characteristics and to record associated clinical outcomes in a manner that facilitates relevant comparison of outputs with that of devices approved in the U.S. for clearing Large Vessel Occlusions.


Eligibility criteria: Inclusion Criteria:

1. The patient or the patient's legally authorized representative has signed and dated an Informed Consent Form.
2. Aged between 18 years and 85 years (inclusive).
3. A new focal disabling neurologic deficit consistent with acute cerebral ischemia.
4. NIHSS score ≥8 and ≤25.
5. Pre-ictal mRS score of 0 or 1.
6. The interventionalist estimates that at least one deployment of the EmboTrap device can be completed within 8 hours from the onset of symptoms.
7. Patients for whom IV-tPA is indicated and who are available for treatment, are treated with IV-tPA.
8. IV-tPA, if used, was initiated within 3 hrs of stroke onset (onset time is defined as the last time when the patient was witnessed to be at baseline), with investigator verification that the subject has received/is receiving the correct IV t-PA dose for the estimated weight.
9. Angiographic confirmation of an occlusion of an ICA (including T or L occlusions), M1 or M2 MCA, VA, or BA with mTICI flow of 0 - 1.
10. For strokes in the anterior circulation the following imaging criteria should also be met:

    1. MRI criterion: volume of diffusion restriction visually assessed ≤50 mL. OR
    2. CT criterion: ASPECTS 6 to 10 on baseline CT or CTA-source images, or, volume of significantly lowered CBV ≤50 mL.
11. The patient is indicated for neurothrombectomy treatment by the interventionalist and it is confirmed by diagnostic angiography that the device will be able to reach the target lesion proximally.

Exclusion Criteria:

1. Life expectancy likely less than 6 months.
2. Females who are pregnant or breastfeeding.
3. History of severe allergy to contrast medium.
4. Known nickel allergy at time of treatment.
5. Known current use of cocaine at time of treatment.
6. Patient has suffered a stroke in the past 3 months.
7. The patient presents with an NIHSS score \<8 or \>25 or is physician assessed as being in a clinically relevant uninterrupted coma.
8. Subject participating in another study involving an investigational device or drug.
9. Use of warfarin anticoagulation or any Novel Anticoagulant with International Normalized Ratio (INR) \>3.0.
10. Platelet count \<50,000/μL.
11. Glucose \<50 mg/dL.
12. Any known hemorrhagic or coagulation deficiency.
13. Unstable renal failure with serum creatinine \>3.0 or Glomerular Filtration Rate (GFR) \<30.
14. Patients who have received a direct thrombin inhibitor within the last 48 hours; must have a partial thromboplastin time (PTT) less than 1.5 times the normal to be eligible.
15. All patients with severe hypertension on presentation (SBP\> 220mmHg and/or DBP\>120mmHg). All patients, in whom intravenous therapy with blood pressure medications is indicated, with hypertension that remains severe and sustained despite intravenous therapy (SBP \>185mmHg and/or DBP\>110mmHg). .
16. Known cerebral vasculitis.
17. Rapidly improving neurological status.
18. Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories.
19. Ongoing seizure due to stroke.
20. Evidence of active systemic infection.
21. Known cancer with metastases.
22. Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh hemorrhage on presentation.
23. Baseline computed tomography (CT) or MRI showing mass effect or intracranial tumor (except small meningioma).
24. Suspicion of aortic dissection, presumed septic embolus, or suspicion of bacterial endocarditis.
25. Stenosis, or any occlusion, in a proximal vessel that requires treatment or prevents access to the site of occlusion.
26. Evidence of dissection in the extra or intracranial cerebral arteries.
27. Occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation).

Primary outcomes:
measure: Successful Revascularization Measured Using Modified Thrombolysis in Cerebrovascular Infarction (mTICI Inclusive of the 2c Rating)
timeFrame: Post-treatment
measure: Occurrence of Symptomatic Intracerebral Hemorrhage (sICH) Within 24 Hours Post-procedure and Any Other Serious Adverse Device Effects (SADE)
timeFrame: 24(-8/+12 hrs) hours post-procedure and 90(±14) days Post Procedure
Secondary outcomes:
measure: Good Clinical Outcome as Defined by Modified Rankin Scale (mRS) Score ≤2
timeFrame: 90(±14) days Post Procedure
measure: Procedure Time
timeFrame: Post-treatment
measure: All Procedure-related Mortality
timeFrame: Day 7 post-procedure
measure: All-cause Mortality
timeFrame: 90(±14) days Post Procedure
measure: Occurrence of Serious Adverse Device Effects (SADE)
timeFrame: 90(±14) days Post Procedure
measure: Occurrence of Procedure Related Serious Adverse Events (PRSAE)
timeFrame: 90(±14) days Post Procedure
measure: Occurrence of Symptomatic Intracerebral Hemorrhage (sICH)
timeFrame: 24(-8/+12) hours post-procedure
measure: Occurrence of Neurological Deterioration
timeFrame: 24(-8/+12) hours post-procedure
measure: Proportion of Subjects With Evidence of Infarction of a Previously Uninvolved Vascular Territory
timeFrame: 24(-8/+12) hours post-procedure
measure: Time to Treat
timeFrame: Post-treatment
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
city: San Jose
country: United States
facility: Good Samaritan Hospital and Regional Medical Center
state: California
city: Miami
country: United States
facility: University of Miami and Jackson Memorial Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University School of Medicine,
state: Georgia
city: Columbus
country: United States
facility: Riverside Radiology and Interventional Associates
state: Ohio
city: Toledo
country: United States
facility: St Vincent Mercy Hospital
state: Ohio
city: Portland
country: United States
facility: OHSU Stroke Center
state: Oregon
city: Pittsburgh
country: United States
facility: UPMC Stroke Center
state: Pennsylvania
city: Chattanooga
country: United States
facility: Tennessee Interventional and Imaging Associates
state: Tennessee
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Kiel
country: Germany
facility: UKSH Campus Kiel
city: Dublin
country: Ireland
facility: Beaumont Hospital
Study officials:
affiliation: St. Vincent Mercy Mercy Hospital, Toledo,Ohio, USA
name: Prof. Sam Zaidat, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska Institutet
name: Prof. Tommy Andersson, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: UCLA, CA, USA.
name: Prof. Jeffery Saver, M.D.
role: STUDY_DIRECTOR
affiliation: University of Berne, Berne, Switzerland.
name: Prof. Heinrich Mattle, M.D.
role: STUDY_DIRECTOR
References:
citation: Yoo AJ, Soomro J, Andersson T, Saver JL, Ribo M, Bozorgchami H, Dabus G, Liebeskind DS, Jadhav A, Mattle H, Zaidat OO. Benchmarking the Extent and Speed of Reperfusion: First Pass TICI 2c-3 Is a Preferred Endovascular Reperfusion Endpoint. Front Neurol. 2021 May 11;12:669934. doi: 10.3389/fneur.2021.669934. eCollection 2021.
citation: Zaidat OO, Bozorgchami H, Ribo M, Saver JL, Mattle HP, Chapot R, Narata AP, Francois O, Jadhav AP, Grossberg JA, Riedel CH, Tomasello A, Clark WM, Nordmeyer H, Lin E, Nogueira RG, Yoo AJ, Jovin TG, Siddiqui AH, Bernard T, Claffey M, Andersson T. Primary Results of the Multicenter ARISE II Study (Analysis of Revascularization in Ischemic Stroke With EmboTrap). Stroke. 2018 May;49(5):1107-1115. doi: 10.1161/STROKEAHA.117.020125. Epub 2018 Apr 11.