WOLF - Feasibility Neurothrombectomy Study in Acute Ischemic Stroke Patients (WOLF)

WOLF - Prospective Feasibility Clinical Investigation to Evaluate the Safety and Technical Performance of the WOLF Thrombectomy Device in Acute Ischemic Stroke Patients

This study is being conducted as a feasibility clinical investigation to collect safety and technical performance data of the WOLF Thrombectomy Device for the removal of thrombus in the neurovasculature.

Study Overview

• Status: Withdrawn
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Device: WOLF Thrombectomy Device

Detailed Description

This study has been designed as a prospective, non-randomized, multi-center, feasibility clinical investigation to evaluate the safety and device technical performance of the WOLF Thrombectomy Device in removing thrombus from an occluded large intracranial vessel(s) in patients with acute ischemic stroke. The device may be used alone or as an adjunct to intravenous tissue plasminogen activator (tPA) and/or to other traditional, thrombectomy modalities.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Hamilton General Hospital
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N5A2
      • Royal University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female subjects age ≥18 years (no upper limit).
2. NIHSS > 6 at the time of baseline neuro imaging.
3. Endovascular treatment intended to be initiated within 60 minutes of qualifying neuroimaging and intended vessel recanalization within 90 minutes of qualifying neuroimaging.
4. Stroke symptom onset within 24hrs of when groin puncture can be obtained.
5. Anterior and posterior circulation large vessel occlusion as confirmed through neuro imaging (CT/CTA/mCTA/MRI/MRA).
6. Neurovascular imaging (CTA/mCTA and or MRA) must include the aortic arch, cervical vessels and intracranial circulation.
7. Advanced neurovascular imaging is required for patients when groin puncture can be obtained after 6 hours and before 24 hours (multiphase CTA, CT Perfusion or perfusion diffusion imaging).
8. The occlusion is located in a proximal intracranial artery (carotid artery, M1 segment of the MCA, or proximal M2 divisions) of the anterior circulation for patients after 6 hours and before 24 hours.

9. There is imaging and clinical evidence of small core and large areas at risk, defined in the previous trials (DAWN & DEFUSE 3) as either:

   i. NIHSS ≥10 and either 0-21 ml core infarct (≥80 years old) or 0-31 ml core infarct (<80 years old), or NIHSS≥20 and 31 to <51ml core infarct and <80 years old (DAWN trial criteria).

   OR ii. Ischemic core volume is < 70 ml, mismatch ratio is >/= 1.8 and mismatch volume* is >/= 15 ml (DEFUSE 3 trial criteria).

10. Pre-stroke disability limited to patients with mRS ≤ 2.
11. Written informed consent to participate given by subject or legal / authorized representative per local ethics committee requirements.

Exclusion Criteria:

1. Female subject is known to be pregnant.
2. Absence of large vessel occlusion on neuro imaging.
3. Presence of existing or preexisting large vessel infarction.
4. Angiographic evidence of excessive arterial tortuosity or access that precludes the WOLF device from reaching the thrombus.
5. Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR >2.5.
6. Patient has a known hypersensitivity to contrast media.
7. Medical reasons the procedure cannot be performed (i.e. patient is experiencing active, uncontrolled bleeding, etc.)
8. Subject is known to be currently enrolled in another investigational trial that could interfere with the endpoint analysis of this trial.
9. ASPECT < 5 or > 1/3 MCA vascular territory compromised as evidenced by CT or MRI.
10. Significant mass effect and mid-line shift.
11. Any evidence of intracranial hemorrhage on imaging.
12. For posterior circulation large vessel occlusion evidence of completed significant brain stem infarction.
13. Posterior circulation after 6 hours.
14. Patients are known to have severe psychiatric disorders, substance abuse, or other reason for being unable to follow trial follow-up instructions.
15. Subject has a known significant concomitant illness with a life expectancy of <6 months.
16. Subject has a known allergy to nickel.
17. Subject has a known history of severe intracranial atherosclerotic disease (ICAD).
18. Subject is unlikely to be able and willing to comply with site standard medical follow up to 90 days.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: WOLF Thrombectomy Device Arm; Patients enrolled in the study who received the treatment and who met all Inclusion and Exclusion Criteria	Device: WOLF Thrombectomy Device; Mechanical thrombectomy for the neurovasculature

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Technical Success Endpoint	Technical Success defined as the ability to achieve a revascularization rate (Thrombolysis in cerebral infarction [TICI] 2b/3) of ≥50% with the first pass of the WOLF Thrombectomy device. Revascularization is assessed by the investigator using fluoroscopy and after the first pass of the device is assessed using the TICI scale. Additional passes will be performed as necessary and the total number of attempts to achieve revascularization documented.	At index procedure
Primary Safety Endpoint	WOLF device-related adverse events (incidence, relationship to device and severity) at index procedure and through 24 hours post procedure.	At index procedure and through 24 hours post procedure.

Collaborators and Investigators

• Sponsor: 880 Medical, LLC
• Investigators: Principal Investigator: Brian van Adel, MD, Hamilton General Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 13, 2019
• Primary Completion (ACTUAL): December 30, 2019
• Study Completion (ACTUAL): December 30, 2019

Study Registration Dates

• First Submitted: December 18, 2018
• First Submitted That Met QC Criteria: December 18, 2018
• First Posted (ACTUAL): December 20, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 23, 2020
• Last Update Submitted That Met QC Criteria: January 21, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction
• Other Study ID Numbers: CLIN 0001-CAN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes