Ischemic StrokeNCT03871309
Tigertriever Distal Vessels Registry
An observational study of Ischemic Stroke, run by Rapid Medical at 1 site in United Kingdom.
Trial summary
A registry study to collect data on the Tigertriever device at restoring blood flow by removing clots in M2 or distal vessels in patients experiencing acute ischemic stroke, during commercial use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Tigertriever
- Type of treatment
- Medical device
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Feb 2020to 10 Oct 2023
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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
Study population: Male or female patients (age ≥18) who present with an acute ischemic stroke due to a M2 or distal (medium to small) vessel occlusion confirmed by vessel imaging and treated with the Tigertriever 17 or 13 revascularization devices.
Who may be able to join
- Patients who present with acute ischemic stroke, who can be treated within 6 hours of symptoms onset, who are either refractory to or ineligible for IV t-PA treatment and intend to be treated with thrombectomy.
- Patients ≥18
- NIHSS Score of ≥2
- Angiographically confirmed occlusion in a M2 or distal (medium to small) branch that is accessible to the Tigertriever device (17 or 13) as determined by the vessel diameter (≥1mm).
- Anticipated life expectancy of at least 6 months from presentation
- Signed informed consent form by the patient or a legally acceptable representative.
Who cannot join
- Extended infarct - ischemic changes >1/3 MCA territory / 100 ml tissue or ASPECT score <5
- Pre- stroke mRS ≥ 2
- Unknown time of stroke symptom onset
- Vessel diameter < 1mm
- Angiographically evident extreme vessel tortuosity that may preclude the device from reaching the target area.
- Occlusion/stenosis proximal to thrombus that precludes safe retrieval
Show all 19Show fewer
- Medical co-morbidities including but not limited to:
- Uncontrolled coagulopathy such as International Normalized Ratio (INR) of > 3.0 or platelets count < 40 x109/L or APTT >50 sec
- Serious concurrent medical illness: myocardial infarction, seizures, sepsis, uncontrolled diabetes, uncontrolled hypertension, brain tumor, renal impairment (eGFR <60).
- Baseline glucose < 2.7 or > 22.2 mmol/L
- Imaging features of:
- raised intracranial pressure or significant mass effect (for example, midline shift, severe sulcal effacement, transcompartmental herniation)
- intracranial hemorrhage
- vascular malformation or aneurysm
- significant vascular abnormality such as carotid dissection, complete carotid occlusion or large/medium vessel vasculitis
- Allergy/sensitivity to nickel-titanium or contrast media
- Females who are pregnant or lactating
- Unable to obtain informed consent from the patient or a suitable legal representative
- Any other contraindication to thrombectomy
Trial locations and contacts
1 site in 1 country.
About this study
A registry study to collect data on the Tigertriever device at restoring blood flow by removing clots in M2 or distal vessels in patients experiencing acute ischemic stroke, during commercial use.
Read the detailed description
Tigertriever is a CE marked mechanical revascularization device indicated to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset.
- Conditions
- Ischemic Stroke
- Being tested
- Tigertriever
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TigertrieverDevice
Mechanical Thrombectomy
| Study group | Role | What they receive |
|---|---|---|
| Tigertriever | Male or female patients (age ≥18) who present with an acute ischemic stroke due to a M2 or distal (medium to small) vessel occlusion confirmed by vessel imaging and treated with the Tigertriever 17 or 13 revascularization devices. Receives: Device: Tigertriever |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with Symptomatic Intracranial Hemorrhage (SICH) or new infarct within 24 (±12) hours post-procedure.
Safety Endpoints. SICH shall be defined as Parenchymal Hematoma type 2 coupled with ≥4-point NIHSS deterioration at 24 hours.
Measured: 24 hours post procedure
Percentage of participants with a new occlusion.
Safety Endpoints.
Measured: Day 0 (end of procedure)
Percentage of participants with a TICI Score ≥IIb post procedure.
Effectiveness Endpoints
Measured: Day 0 (end of procedure)
Percentage of participants with a TICI Score ≥IIb post procedure after first pass.
Effectiveness Endpoints
Measured: Day 0 (end of procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start7 Feb 2020
- Primary completion4 Aug 2022
- Study completion10 Oct 2023
Why it stopped: PI and sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Rapid Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyri Lobotesis, MD, Principal investigator, Imperial College Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03871309
- Sponsor's protocol ID
- 005-035-006-ANTR-0607
- Status last verified
- Oct 2022
- First submitted
- 21 Feb 2019
- Last updated
- 12 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tigertriever Distal Vessels Registry
- ClinicalTrials.gov ID
- NCT03871309
- Acronym / sponsor ID
- 005-035-006-ANTR-0607
- Conditions
- Ischemic Stroke
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI and sponsor decision
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Rapid MedicalIndustry (pharma, biotech, devices)
- Study start
- 7 Feb 2020 (actual)
- Primary completion
- 4 Aug 2022 (actual)
- Study completion
- 10 Oct 2023 (actual)
- First posted
- 12 Mar 2019 (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.
A registry study to collect data on the Tigertriever device at restoring blood flow by removing clots in M2 or distal vessels in patients experiencing acute ischemic stroke, during commercial use.
Detailed description
Tigertriever is a CE marked mechanical revascularization device indicated to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tigertriever | – | Device: TigertrieverMale or female patients (age ≥18) who present with an acute ischemic stroke due to a M2 or distal (medium to small) vessel occlusion confirmed by vessel imaging and treated with the Tigertriever 17 or 13 revascularization devices. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male or female patients (age ≥18) who present with an acute ischemic stroke due to a M2 or distal (medium to small) vessel occlusion confirmed by vessel imaging and treated with the Tigertriever 17 or 13 revascularization devices.
Key inclusion criteria (6 listed)
- Patients who present with acute ischemic stroke, who can be treated within 6 hours of symptoms onset, who are either refractory to or ineligible for IV t-PA treatment and intend to be treated with thrombectomy.
- Patients ≥18
- NIHSS Score of ≥2
- Angiographically confirmed occlusion in a M2 or distal (medium to small) branch that is accessible to the Tigertriever device (17 or 13) as determined by the vessel diameter (≥1mm).
- Anticipated life expectancy of at least 6 months from presentation
Key exclusion criteria (19 listed)
- Extended infarct - ischemic changes >1/3 MCA territory / 100 ml tissue or ASPECT score <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 |
|---|---|---|
| TigertrieverMechanical Thrombectomy | Device | Tigertriever |
Primary outcome
Percentage of participants with Symptomatic Intracranial Hemorrhage (SICH) or new infarct within 24 (±12) hours post-procedure.
Time frame: 24 hours post procedure
Safety Endpoints. SICH shall be defined as Parenchymal Hematoma type 2 coupled with ≥4-point NIHSS deterioration at 24 hours.
Percentage of participants with a new occlusion.
Time frame: Day 0 (end of procedure)
Safety Endpoints.
Percentage of participants with a TICI Score ≥IIb post procedure.
Time frame: Day 0 (end of procedure)
Effectiveness Endpoints
Percentage of participants with a TICI Score ≥IIb post procedure after first pass.
Time frame: Day 0 (end of procedure)
Effectiveness Endpoints
Results and safety
The study was stopped early (reason given: PI and sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Ischemic Stroke
Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingPhase 3
Probucol for Symptomatic Intracranial and Extracranial Artery Stenosis
Ischemic Stroke, TIA
Recruiting
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
Paralysis; Quadriplegic, Quadraplegia
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.
Kyri Lobotesis, MD principal investigator
Imperial College Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by Rapid Medical at 1 site in United Kingdom.
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 6 inclusion and 19 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: stopped early, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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 stopped early (reason given: PI and sponsor decision). Results are not available in the source record.
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?
Percentage of participants with Symptomatic Intracranial Hemorrhage (SICH) or new infarct within 24 (±12) hours post-procedure. (time frame: 24 hours post procedure). The study lists 4 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 12 Apr 2024.