Acute Ischemic StrokeWOLFNCT03781622
WOLF - Feasibility Neurothrombectomy Study in Acute Ischemic Stroke Patients
A study testing WOLF Thrombectomy Device in people with Acute Ischemic Stroke, run by 880 Medical, LLC at 2 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- WOLF Thrombectomy Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesCanada
- Study dates
- 13 Jun 2019to 30 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects age ≥18 years (no upper limit).
- NIHSS > 6 at the time of baseline neuro imaging.
- Endovascular treatment intended to be initiated within 60 minutes of qualifying neuroimaging and intended vessel recanalization within 90 minutes of qualifying neuroimaging.
- Stroke symptom onset within 24hrs of when groin puncture can be obtained.
- Anterior and posterior circulation large vessel occlusion as confirmed through neuro imaging (CT/CTA/mCTA/MRI/MRA).
- Neurovascular imaging (CTA/mCTA and or MRA) must include the aortic arch, cervical vessels and intracranial circulation.
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- 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).
- 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.
- There is imaging and clinical evidence of small core and large areas at risk, defined in the previous trials (DAWN \& DEFUSE 3) as either:
- 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).
- Pre-stroke disability limited to patients with mRS ≤ 2.
- Written informed consent to participate given by subject or legal / authorized representative per local ethics committee requirements.
Who cannot join
- Female subject is known to be pregnant.
- Absence of large vessel occlusion on neuro imaging.
- Presence of existing or preexisting large vessel infarction.
- Angiographic evidence of excessive arterial tortuosity or access that precludes the WOLF device from reaching the thrombus.
- Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR >2.5.
- Patient has a known hypersensitivity to contrast media.
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- Medical reasons the procedure cannot be performed (i.e. patient is experiencing active, uncontrolled bleeding, etc.)
- Subject is known to be currently enrolled in another investigational trial that could interfere with the endpoint analysis of this trial.
- ASPECT < 5 or > 1/3 MCA vascular territory compromised as evidenced by CT or MRI.
- Significant mass effect and mid-line shift.
- Any evidence of intracranial hemorrhage on imaging.
- For posterior circulation large vessel occlusion evidence of completed significant brain stem infarction.
- Posterior circulation after 6 hours.
- Patients are known to have severe psychiatric disorders, substance abuse, or other reason for being unable to follow trial follow-up instructions.
- Subject has a known significant concomitant illness with a life expectancy of <6 months.
- Subject has a known allergy to nickel.
- Subject has a known history of severe intracranial atherosclerotic disease (ICAD).
- Subject is unlikely to be able and willing to comply with site standard medical follow up to 90 days.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
Royal University Hospital
Saskatoon, Saskatchewan, S7N5A2
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- WOLF Thrombectomy Device
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WOLF Thrombectomy DeviceDevice
Mechanical thrombectomy for the neurovasculature
| Study group | Role | What they receive |
|---|---|---|
| WOLF Thrombectomy Device Arm | Experimental | Patients enrolled in the study who received the treatment and who met all Inclusion and Exclusion Criteria Receives: Device: WOLF Thrombectomy Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At index procedure and through 24 hours post procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start13 Jun 2019
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
Why it stopped: Poor enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- 880 Medical, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian van Adel, MD, Principal investigator, Hamilton General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03781622
- Sponsor's protocol ID
- CLIN 0001-CAN
- Acronym
- WOLF
- Status last verified
- Jan 2020
- First submitted
- 18 Dec 2018
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WOLF - Prospective Feasibility Clinical Investigation to Evaluate the Safety and Technical Performance of the WOLF Thrombectomy Device in Acute Ischemic Stroke Patients
- ClinicalTrials.gov ID
- NCT03781622
- Acronym / sponsor ID
- WOLF / CLIN 0001-CAN
- Conditions
- Acute Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Poor enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- 880 Medical, LLCIndustry (pharma, biotech, devices)
- Study start
- 13 Jun 2019 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 20 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| WOLF Thrombectomy Device Arm | Experimental | Device: WOLF Thrombectomy DevicePatients enrolled in the study who received the treatment and who met all Inclusion and Exclusion Criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male or female subjects age ≥18 years (no upper limit).
- NIHSS > 6 at the time of baseline neuro imaging.
- Endovascular treatment intended to be initiated within 60 minutes of qualifying neuroimaging and intended vessel recanalization within 90 minutes of qualifying neuroimaging.
- Stroke symptom onset within 24hrs of when groin puncture can be obtained.
- Anterior and posterior circulation large vessel occlusion as confirmed through neuro imaging (CT/CTA/mCTA/MRI/MRA).
Key exclusion criteria (18 listed)
- Female subject is known to be pregnant.
- Absence of large vessel occlusion on neuro imaging.
- Presence of existing or preexisting large vessel infarction.
- Angiographic evidence of excessive arterial tortuosity or access that precludes the WOLF device from reaching the thrombus.
- Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR >2.5.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WOLF Thrombectomy DeviceMechanical thrombectomy for the neurovasculature | Device | WOLF Thrombectomy Device Arm |
Primary outcome
Primary Technical Success Endpoint
Time frame: At index procedure
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.
Primary Safety Endpoint
Time frame: At index procedure and through 24 hours post procedure.
WOLF device-related adverse events (incidence, relationship to device and severity) at index procedure and through 24 hours post procedure.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian van Adel, MD principal investigator
Hamilton General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WOLF Thrombectomy Device in people with Acute Ischemic Stroke, run by 880 Medical, LLC at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Technical Success Endpoint (time frame: At index procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2020.