Analysis of Revascularization in Ischemic Stroke With EmboTrap

NCT02488915 | Completed Results DMC

• 1 other identifier: CIP002
• Study Type: interventional
• Target: 228
• Locations: 4 countries
• Sites: 12

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

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (10)

• Good Clinical Outcome as Defined by Modified Rankin Scale (mRS) Score ≤2

  90(±14) days Post Procedure

• Procedure Time

  Post-treatment

• All Procedure-related Mortality

  Day 7 post-procedure

• All-cause Mortality

  90(±14) days Post Procedure

• Occurrence of Serious Adverse Device Effects (SADE)

  90(±14) days Post Procedure

Study Arms (1)

EmboTrap® Revascularization Device

EXPERIMENTAL

Mechanical Thrombectomy with EmboTrap

Device: EmboTrap® Revascularization Device

Interventions

EmboTrap® Revascularization Device DEVICE

Also known as: EmboTrap II

EmboTrap® Revascularization Device

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient or the patient's legally authorized representative has signed and dated an Informed Consent Form.
• Aged between 18 years and 85 years (inclusive).
• A new focal disabling neurologic deficit consistent with acute cerebral ischemia.
• NIHSS score ≥8 and ≤25.
• Pre-ictal mRS score of 0 or 1.
• The interventionalist estimates that at least one deployment of the EmboTrap device can be completed within 8 hours from the onset of symptoms.
• Patients for whom IV-tPA is indicated and who are available for treatment, are treated with IV-tPA.
• 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.
• 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.
• For strokes in the anterior circulation the following imaging criteria should also be met:
• MRI criterion: volume of diffusion restriction visually assessed ≤50 mL. OR
• CT criterion: ASPECTS 6 to 10 on baseline CT or CTA-source images, or, volume of significantly lowered CBV ≤50 mL.
• 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.

You may not qualify if:

• Life expectancy likely less than 6 months.
• Females who are pregnant or breastfeeding.
• History of severe allergy to contrast medium.
• Known nickel allergy at time of treatment.
• Known current use of cocaine at time of treatment.
• Patient has suffered a stroke in the past 3 months.
• The patient presents with an NIHSS score \<8 or \>25 or is physician assessed as being in a clinically relevant uninterrupted coma.
• Subject participating in another study involving an investigational device or drug.
• Use of warfarin anticoagulation or any Novel Anticoagulant with International Normalized Ratio (INR) \>3.0.
• Platelet count \<50,000/μL.
• Glucose \<50 mg/dL.
• Any known hemorrhagic or coagulation deficiency.
• Unstable renal failure with serum creatinine \>3.0 or Glomerular Filtration Rate (GFR) \<30.
• 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.
• 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). .

Sponsors & Collaborators

• Neuravi Inc.: lead

Study Sites (12)

UCLA

Los Angeles, California, 90095, United States

Location

Good Samaritan Hospital and Regional Medical Center

San Jose, California, 95124, United States

Location

University of Miami and Jackson Memorial Hospital

Miami, Florida, 33136, United States

Location

Emory University School of Medicine,

Atlanta, Georgia, 30303, United States

Location

Riverside Radiology and Interventional Associates

Columbus, Ohio, 43214, United States

Location

St Vincent Mercy Hospital

Toledo, Ohio, 43608, United States

Location

OHSU Stroke Center

Portland, Oregon, 97239, United States

Location

UPMC Stroke Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Tennessee Interventional and Imaging Associates

Chattanooga, Tennessee, 37403, United States

Location

AZ Groeninge

Kortrijk, Belgium

Location

UKSH Campus Kiel

Kiel, Germany

Location

Beaumont Hospital

Dublin, Ireland

Location

Related Publications (2)

• 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.

  PMID: 34046008 DERIVED

• 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.

  PMID: 29643261 DERIVED

MeSH Terms

Conditions

Stroke; Ischemia; Brain Diseases; Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Ischemic Stroke; Vascular Diseases

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infarction; Necrosis

Results Point of Contact

• Title: Mairsíl Claffey
• Organization: Neuravi Ltd

mclaffey@neuravi.com

0035391394123

Study Officials

• Prof. Sam Zaidat, M.D.

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

  PRINCIPAL INVESTIGATOR

• Prof. Tommy Andersson, M.D.

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Prof. Jeffery Saver, M.D.

  UCLA, CA, USA.

  STUDY DIRECTOR

• Prof. Heinrich Mattle, M.D.

  University of Berne, Berne, Switzerland.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2015
• First Posted: July 2, 2015
• Study Start: November 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: September 1, 2017
• Last Updated: July 13, 2018
• Results First Posted: July 13, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1); US (9); DE (1); BE (1)