Ischemic StrokeTRACNCT05270122
ThrombX Retriever for Acute Ischemic Stroke Trial
A study testing Mechanical thrombectomy with ThrombX Retriever in people with Ischemic Stroke, run by ThrombX Medical.
Trial summary
This trial is designed to assess the safety and effectiveness of the ThrombX Retriever. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Mechanical thrombectomy with ThrombX Retriever
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- May 2022to Jul 2024
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute anterior circulation ischemic stroke
- Pre-stroke Modified Rankin Score ≤ 1
- NIHSS ≥ 6 and < 25 immediately prior to enrollment
- ASPECT score ≥6 with CT scanning or core infarct volume <50 mL on magnetic MRI or CT based perfusion imaging
- Occlusion of IC or the middle cerebral artery M1 or M2 division
- Subject can be treated within eight-hours of onset of stroke symptoms
Who cannot join
- Pregnant or lactating at time of admission
- Known serious sensitivity to radiographic contrast agents
- Known sensitivity to nickel, titanium metals, or their alloys
- Current participation in another investigation drug or device treatment study
- Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency prothrombin time lab results to be available prior to enrollment)
- Renal failure
Show all 19Show fewer
- Baseline blood glucose of <50mg/dL (2.78 mmol/L) or >400mg/dL (22.20 mmol/L)
- Baseline platelet count < 50,000/uL
- Severe, sustained hypertension
- Presumed septic embolus, suspicion of bacterial endocarditis
- Subject has a contraindication to an angiogram
- Life expectancy <6 months
- Comorbid disease or condition that would confound assessments
- Known history of arterial tortuosity, preexisting stent, and/or other arterial disease
- Tandem lesions, occlusion requiring angioplasty and/or stent placement or evidence of carotid dissection
- Site of occlusion is heavily calcified
- Imaging or clinical evidence of bilateral strokes or concomitant posterior circulation stroke
- CT or MRI evidence of hemorrhage or evidence of mass effect or intra-cranial tumor
- Imaging evidence suggests subject is not appropriate for mechanical thrombectomy
Trial locations and contacts
No sites are listed yet.
About this study
This trial is designed to assess the safety and effectiveness of the ThrombX Retriever.
Read the detailed description
This trial is a clinical evaluation is to assess the safety and effectiveness of the ThrombX Retriever in the revascularization of the site of primary occlusion in patients presenting with acute ischemic stroke secondary to intracranial, large vessel, occlusive disease.
- Conditions
- Ischemic Stroke
- Being tested
- Mechanical thrombectomy with ThrombX Retriever
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical thrombectomy with ThrombX RetrieverDevice
Also called Mechanical Thrombectomy
Revascularization
| Study group | Role | What they receive |
|---|---|---|
| ThrombX Retriever | Experimental | Access to the involved vasculature and preform mechanical thrombectomy using the ThrombX Retriever. Receives: Device: Mechanical thrombectomy with ThrombX Retriever |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful reperfusion of the occluded target vessel with up to 3 passes of the ThrombX Retriever
Defined by a mTICI score >2b
Measured: Up to the end of theprocedure
Safety Endpoint
Symptomatic intracerebral hemorrhage (sICH) confirmed on imaging and other Serious Adverse Device Effects (SADE) within 24 hours post procedure. The sICH is defined as the presence of extravascular blood in the cranium associated with an increase in the NIHSS score of ≥ 4 points or death.
Measured: 24 hours
Secondary outcomes (1)
Functional independence defined by modified Rankin Scale (mRS)
modified Ranking Scale is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. The scale runs from 0-6, running from perfect health without symptoms to death.
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 posted8 Mar 2022
- Study startMay 2022 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionJul 2024 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group assignment
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ThrombX Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mahesh Jayaraman, MD, Principal investigator, Rhode Island HospitalRaul Nogueira, MD, MD, Principal investigator, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05270122
- Sponsor's protocol ID
- T0268
- Acronym
- TRAC
- Status last verified
- Mar 2022
- First submitted
- 17 Feb 2022
- Last updated
- 28 Mar 2022
- 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 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ThrombX Retriever for Acute Ischemic Stroke Trial
- ClinicalTrials.gov ID
- NCT05270122
- Acronym / sponsor ID
- TRAC / T0268
- Conditions
- Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- ThrombX MedicalIndustry (pharma, biotech, devices)
- Study start
- May 2022 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 8 Mar 2022 (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 trial is designed to assess the safety and effectiveness of the ThrombX Retriever.
Detailed description
This trial is a clinical evaluation is to assess the safety and effectiveness of the ThrombX Retriever in the revascularization of the site of primary occlusion in patients presenting with acute ischemic stroke secondary to intracranial, large vessel, occlusive disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group assignment
| Arm | Type | Receives |
|---|---|---|
| ThrombX Retriever | Experimental | Device: Mechanical thrombectomy with ThrombX RetrieverAccess to the involved vasculature and preform mechanical thrombectomy using the ThrombX Retriever. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Acute anterior circulation ischemic stroke
- Pre-stroke Modified Rankin Score ≤ 1
- NIHSS ≥ 6 and < 25 immediately prior to enrollment
- ASPECT score ≥6 with CT scanning or core infarct volume <50 mL on magnetic MRI or CT based perfusion imaging
- Occlusion of IC or the middle cerebral artery M1 or M2 division
Key exclusion criteria (19 listed)
- Pregnant or lactating at time of admission
- Known serious sensitivity to radiographic contrast agents
- Known sensitivity to nickel, titanium metals, or their alloys
- Current participation in another investigation drug or device treatment study
- Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency prothrombin time lab results to be available prior to enrollment)
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 |
|---|---|---|
| Mechanical thrombectomy with ThrombX RetrieverAlso: Mechanical ThrombectomyRevascularization | Device | ThrombX Retriever |
Primary outcome
Successful reperfusion of the occluded target vessel with up to 3 passes of the ThrombX Retriever
Time frame: Up to the end of theprocedure
Defined by a mTICI score >2b
Safety Endpoint
Time frame: 24 hours
Symptomatic intracerebral hemorrhage (sICH) confirmed on imaging and other Serious Adverse Device Effects (SADE) within 24 hours post procedure. The sICH is defined as the presence of extravascular blood in the cranium associated with an increase in the NIHSS score of ≥ 4 points or death.
1 secondary outcome
Functional independence defined by modified Rankin Scale (mRS)
Time frame: 90 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2022.
- 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.
Mahesh Jayaraman, MD principal investigator
Rhode Island Hospital
Raul Nogueira, MD, MD principal investigator
University of Pittsburgh Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical thrombectomy with ThrombX Retriever in people with Ischemic Stroke, run by ThrombX Medical.
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: status not confirmed, as of the sponsor's last update on 28 Mar 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claire Houston, MS (65052453467, chouston@thrombxmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful reperfusion of the occluded target vessel with up to 3 passes of the ThrombX Retriever (time frame: Up to the end of theprocedure). 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 28 Mar 2022.