Analysis of Revascularization in Ischemic Stroke With EmboTrap

NCT ID: NCT02488915

Last Updated: 2018-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 228 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2017-09-30

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.

Conditions

Stroke; Ischemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EmboTrap® Revascularization Device

Mechanical Thrombectomy with EmboTrap

Group Type: EXPERIMENTAL

EmboTrap® Revascularization Device

Intervention Type: DEVICE

Interventions

EmboTrap® Revascularization Device

Intervention Type: DEVICE

Other Intervention Names

EmboTrap II

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neuravi Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Prof. Sam Zaidat, M.D.

Role: PRINCIPAL_INVESTIGATOR

St. Vincent Mercy Mercy Hospital, Toledo,Ohio, USA

Prof. Tommy Andersson, M.D.

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Prof. Jeffery Saver, M.D.

Role: STUDY_DIRECTOR

UCLA, CA, USA.

Prof. Heinrich Mattle, M.D.

Role: STUDY_DIRECTOR

University of Berne, Berne, Switzerland.

Locations

UCLA

Los Angeles, California, United States

Good Samaritan Hospital and Regional Medical Center

San Jose, California, United States

University of Miami and Jackson Memorial Hospital

Miami, Florida, United States

Emory University School of Medicine,

Atlanta, Georgia, United States

Riverside Radiology and Interventional Associates

Columbus, Ohio, United States

St Vincent Mercy Hospital

Toledo, Ohio, United States

OHSU Stroke Center

Portland, Oregon, United States

UPMC Stroke Center

Pittsburgh, Pennsylvania, United States

Tennessee Interventional and Imaging Associates

Chattanooga, Tennessee, United States

AZ Groeninge

Kortrijk, , Belgium

UKSH Campus Kiel

Kiel, , Germany

Beaumont Hospital

Dublin, , Ireland

Countries

United States; Belgium; Germany; Ireland

References

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.

Reference Type: DERIVED

PMID: 34046008 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29643261 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CIP002

Identifier Type: -

Identifier Source: org_study_id