Acute Ischemic StrokeTRUSTNCT03754296
Treatment of Acute Ischemic Stroke With CATCHVIEW Stent Retriever in Comparison to SOLITAIRE 2/FR
An observational study of Acute Ischemic Stroke, run by Balt Extrusion.
Trial summary
The TRUST study is a non-interventional, prospective, multicenter, international, single arm and non-inferiority study. It is designed to evaluate the efficacy and safety of mechanical thrombectomy of the CATCHVIEW device compared to SOLITAIRE 2/FR based on an objective performance criterion (OPC) defined with… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- CATCHVIEW
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2018to Mar 2020
- 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 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients with acute onset of stroke symptoms leading to significant clinical deficit in the setting of an angiographically proven occlusion of a proximal intracranial artery (intracranial internal carotid, middle cerebral M1 and/or M2 segments, carotid terminus or tandem proximal ICA/MCA-M1) who could have endovascular therapy (defined as the first pass with assigned study device) started within 8h of onset of stroke symptoms will be eligible for the study.
Who may be able to join
- Age ≥ 18 and ≤ 80 years old
- Clinical signs consistent with acute ischemic stroke
- Pre-stroke modified Rankin Score ≤ 1
- Patient able to be treated within 8 hours of onset of stroke symptoms and within 2 hours between qualifying imaging from CTA or MRA to groin puncture
- Initial NIHSS ≥ 6 and < 30 at the time of inclusion
- Arterial occlusion in the intracranial internal carotid, M1/M2 segment of the MCA, carotid terminus or tandem proximal ICA/MCA-M1 confirmed by CT or MR angiography that is accessible to the device
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- Acute ischemic stroke where patient is ineligible for IV thrombolytic treatment or the treatment is contraindicated (e.g., patient presents beyond recommended time from symptom onset), or where patient has received IV thrombolytic therapy without partial or complete recanalization
- Primary use of the CATCHVIEW stent retriever for the procedure (decision of use is done independently and prior to the participation of the patient in the study)
- Life expectancy of at least 90 days
- Ability of the patient or legally authorized representative to provide a signed and dated informed consent form before the procedure. Where applicable, in case of medical emergency not allowing the patient to provide consent and unavailability of the legally authorized representative, a physician who does not take part in the study will sign the informed consent before the procedure. In any case, the patient or the legally authorized representative consent shall be requested as soon as possible after the procedure up until the discharge visit.
Who cannot join
- Clinical exclusion criteria
- Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT or MRI scan is normal
- Suspicion of aortic dissection
- Patient with a co-morbid disease or condition that would confound the neurological and functional evaluations or compromise survival or ability to complete follow-up assessments within 90 days
- Known history of other arterial disease that would prevent the device from reaching the target vessel and/or preclude safe recovery of the device
- Patient who requires hemodialysis or peritoneal dialysis, or who have contraindication to an angiogram for whatever reason
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- Serious sensitivity to radiographic contrast agents
- Sensitivity to nickel-titanium
- Patient with stenosis proximal to the thrombus site that may preclude safe recovery of the device
- Inability to reach the occlusion site
- Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR>3.0
- Current participation in an interventional investigation drug or device treatment study
- Pregnant women
- Imaging exclusion criteria
- Baseline non-contrast CT or DWI MRI evidence of a moderate/large core defined as extensive early ischemic changes of Alberta Stroke Program Early CT score (ASPECTS) < 6
- Imaging evidence that suggests, in the opinion of the Investigator, the patient is not appropriate for mechanical thrombectomy intervention (e.g. inability to navigate to target lesion, moderate/large infarct with poor collateral circulation, etc.)
- CT or MRI evidence of hemorrhage on presentation
- CT or MRI evidence of mass effect or intra-cranial tumour (except small meningioma)
- Imaging evidence of cerebral vasculitis
- CT or MRI showing an infarction core involving greater than 1/3 of the MCA territory (or in other territories > 100 cc of tissue) on presentation
- CT or MRI evidence of a basilar artery (BA) occlusion or posterior cerebral artery (PCA) occlusion
About this study
Official title: Treatment of Acute Ischemic Stroke With CATCHVIEW Stent Retriever in Comparison to SOLITAIRE 2/FR - the TRUST Study - a Non-interventional, International, Multicenter, Prospective, Single-arm Study Based on an Objective Performance Criterion
The TRUST study is a non-interventional, prospective, multicenter, international, single arm and non-inferiority study. It is designed to evaluate the efficacy and safety of mechanical thrombectomy of the CATCHVIEW device compared to SOLITAIRE 2/FR based on an objective performance criterion (OPC) defined with available and published clinical evidence gathered through the Solitaire clinical trials in the arterial revascularization of patients with acute ischemic stroke.
- Conditions
- Acute Ischemic Stroke
- Being tested
- CATCHVIEW
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CATCHVIEWDevice
Revascularization device
| Study group | Role | What they receive |
|---|---|---|
| CATCHVIEW stent retriever | Not described Receives: Device: CATCHVIEW |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Rankin Score (mRS)
Proportion of patients achieving functional independence (mRS ≤ 2)
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study startDec 2018 (estimated)
- Primary completionMar 2020 (estimated)
- Study completionMar 2020 (estimated)
Why it stopped: Strategic decision
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balt Extrusion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03754296
- Sponsor's protocol ID
- CIP-201703-CATCH
- Acronym
- TRUST
- Status last verified
- Jan 2020
- First submitted
- 23 Nov 2018
- Last updated
- 9 Jan 2020
- Results posted
- No
- Data monitoring committee
- 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 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Acute Ischemic Stroke With CATCHVIEW Stent Retriever in Comparison to SOLITAIRE 2/FR - the TRUST Study - a Non-interventional, International, Multicenter, Prospective, Single-arm Study Based on an Objective Performance Criterion
- ClinicalTrials.gov ID
- NCT03754296
- Acronym / sponsor ID
- TRUST / CIP-201703-CATCH
- Conditions
- Acute Ischemic Stroke
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Strategic decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Balt ExtrusionIndustry (pharma, biotech, devices)
- Study start
- Dec 2018 (estimated)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 27 Nov 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.
The TRUST study is a non-interventional, prospective, multicenter, international, single arm and non-inferiority study. It is designed to evaluate the efficacy and safety of mechanical thrombectomy of the CATCHVIEW device compared to SOLITAIRE 2/FR based on an objective performance criterion (OPC) defined with available and published clinical evidence gathered through the Solitaire clinical trials in the arterial revascularization of patients with acute ischemic stroke.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CATCHVIEW stent retriever | – | Device: CATCHVIEW |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with acute onset of stroke symptoms leading to significant clinical deficit in the setting of an angiographically proven occlusion of a proximal intracranial artery (intracranial internal carotid, middle cerebral M1 and/or M2 segments, carotid terminus or tandem proximal ICA/MCA-M1) who could have endovascular therapy (defined as the first pass with assigned study device) started within 8h of onset of stroke symptoms will be eligible for the study.
Key inclusion criteria (10 listed)
- Age ≥ 18 and ≤ 80 years old
- Clinical signs consistent with acute ischemic stroke
- Pre-stroke modified Rankin Score ≤ 1
- Patient able to be treated within 8 hours of onset of stroke symptoms and within 2 hours between qualifying imaging from CTA or MRA to groin puncture
- Initial NIHSS ≥ 6 and < 30 at the time of inclusion
Key exclusion criteria (21 listed)
- Clinical exclusion criteria
- Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT or MRI scan is normal
- Suspicion of aortic dissection
- Patient with a co-morbid disease or condition that would confound the neurological and functional evaluations or compromise survival or ability to complete follow-up assessments within 90 days
- Known history of other arterial disease that would prevent the device from reaching the target vessel and/or preclude safe recovery of the device
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 |
|---|---|---|
| CATCHVIEWRevascularization device | Device | CATCHVIEW stent retriever |
Primary outcome
modified Rankin Score (mRS)
Time frame: 90 days
Proportion of patients achieving functional independence (mRS ≤ 2)
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 9 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke, run by Balt Extrusion.
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 10 inclusion and 21 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 9 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
modified Rankin Score (mRS) (time frame: 90 days). 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 9 Jan 2020.