Analysis of Revascularization in Ischemic Stroke With EmboTrap

Stroke Clinical Trial

— ARISEII  

Official title:

ARISE II (Analysis of Revascularization in Ischemic Stroke With EmboTrap) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02488915
• Other study ID #: CIP002
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: September 2017

Study information

• Verified date: June 2018
• Source: Neuravi Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 228
• Est. completion date: September 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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).

Related Conditions & MeSH terms

• Ischemia
• Stroke

Intervention

Device:
• EmboTrap® Revascularization Device

Locations

Country	Name	City	State
Belgium	AZ Groeninge	Kortrijk
Germany	UKSH Campus Kiel	Kiel
Ireland	Beaumont Hospital	Dublin
United States	Emory University School of Medicine,	Atlanta	Georgia
United States	Tennessee Interventional and Imaging Associates	Chattanooga	Tennessee
United States	Riverside Radiology and Interventional Associates	Columbus	Ohio
United States	UCLA	Los Angeles	California
United States	University of Miami and Jackson Memorial Hospital	Miami	Florida
United States	UPMC Stroke Center	Pittsburgh	Pennsylvania
United States	OHSU Stroke Center	Portland	Oregon
United States	Good Samaritan Hospital and Regional Medical Center	San Jose	California
United States	St Vincent Mercy Hospital	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Neuravi Inc.

Countries where clinical trial is conducted

United States,  Belgium,  Germany,  Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful Revascularization Measured Using Modified Thrombolysis in Cerebrovascular Infarction (mTICI Inclusive of the 2c Rating)	Successful achievement of the endpoint is defined as achieving an mTICI score of 2b or greater in the target vessel following 3 or less passes of the EmboTrap device. Patients treated with rescue prior to completion of three passes with EmboTrap were treated as failures to meet the primary revascularization endpoint. (Post measurement of the primary endpoint some patients subsequently received additional treatment.); mTICI is a 6-point grading system for determining the response of thrombolytic therapy for ischaemic stroke: mTICI 0 = No perfusion; mTICI 1 = Penetration but not perfusion; mTICI 2a = Some perfusion with distal branch filling of <50% of territory visualized; mTICI 2b = Substantial perfusion with distal branch filling of =50% of territory visualized; mTICI 2c = Near-complete perfusion; mTICI 3 = Complete perfusion	Post-treatment
Primary	Occurrence of Symptomatic Intracerebral Hemorrhage (sICH) Within 24 Hours Post-procedure and Any Other Serious Adverse Device Effects (SADE)	The primary safety endpoint will be measured as the occurrence of Symptomatic Intracerebral hemorrhage (sICH) within 24 hours (-8/+12 hrs) post-procedure, together with any other Serious Adverse Device Effects (excluding those already counted in sICH).; sICH was assessed using the Heidelberg Bleeding Classification, i.e. any intracerebral hemorrhage associated with an increase of =4 points in the NIHSS scale or an increase of =2 points of a NIHSS subcategory or that leads to major medical intervention. SADE was categorized as any serious adverse event that was deemed to be caused by the study device.	24(-8/+12 hrs) hours post-procedure and 90(±14) days Post Procedure
Secondary	Good Clinical Outcome as Defined by Modified Rankin Scale (mRS) Score =2	Good Clinical Outcome is defined as achieving an mRS score of =2 at 90 days post procedure.; mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. mRS scores range from 0 to 6: mRS 0 = No symptoms.; mRS 1 = No significant disability.; mRS 2 = Slight disability.; mRS 3 = Moderate disability.; mRS 4 = Moderately severe disability.; mRS 5 = Severe disability.; mRS 6 = Dead.	90(±14) days Post Procedure
Secondary	Procedure Time	The time from groin puncture to achievement of mTICI =2b, or if not obtained, to the final angiogram.; mTICI is a 6-point grading system for determining the response of thrombolytic therapy for ischaemic stroke: mTICI 0 = No perfusion; mTICI 1 = Penetration but not perfusion; mTICI 2a = Some perfusion with distal branch filling of <50% of territory visualized; mTICI 2b = Substantial perfusion with distal branch filling of =50% of territory visualized; mTICI 2c = Near-complete perfusion; mTICI 3 = Complete perfusion	Post-treatment
Secondary	All Procedure-related Mortality	Any death that is deemed to have been caused by the study procedure.	Day 7 post-procedure
Secondary	All-cause Mortality	Any death that occurs within 90(±14) days post-procedure.	90(±14) days Post Procedure
Secondary	Occurrence of Serious Adverse Device Effects (SADE)	SADE was categorized as any serious adverse event that was deemed to be caused by the study device.	90(±14) days Post Procedure
Secondary	Occurrence of Procedure Related Serious Adverse Events (PRSAE)	PRSAE was categorized as any serious adverse event that was deemed to be caused by the study procedure.	90(±14) days Post Procedure
Secondary	Occurrence of Symptomatic Intracerebral Hemorrhage (sICH)	sICH was assessed using the Heidelberg Bleeding Classification, i.e. any intracerebral hemorrhage associated with an increase of =4 points in the NIHSS scale or an increase of =2 points of a NIHSS subcategory or that leads to major medical intervention.	24(-8/+12) hours post-procedure
Secondary	Occurrence of Neurological Deterioration	An increase of 4 points or more on the National Institutes of Health Stroke Scale (NIHSS) at 24 hours (-8/+12 hrs) post-procedure. The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. NIHSS scores range from 0 - 42. A score of 0 indicates no stroke symptoms. Higher scores indicate incremental levels of neurological impairment.	24(-8/+12) hours post-procedure
Secondary	Proportion of Subjects With Evidence of Infarction of a Previously Uninvolved Vascular Territory	Infarction (i.e. brain tissue death) of a previously uninvolved vascular territory (i.e. region of the brain) is evaluated from 24-hour imaging (Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)).	24(-8/+12) hours post-procedure
Secondary	Time to Treat	The time from first baseline angiogram to achievement of mTICI =2b, or if not obtained, to the final angiogram.; mTICI is a 6-point grading system for determining the response of thrombolytic therapy for ischaemic stroke: mTICI 0 = No perfusion; mTICI 1 = Penetration but not perfusion; mTICI 2a = Some perfusion with distal branch filling of <50% of territory visualized; mTICI 2b = Substantial perfusion with distal branch filling of =50% of territory visualized; mTICI 2c = Near-complete perfusion; mTICI 3 = Complete perfusion	Post-treatment