Stroke, IschemicTAPASNCT04089917
A Study of the Use of the Q Aspiration Catheter to Remove Clot in Stroke Patients
An observational study of Stroke, Ischemic, run by MIVI Neuroscience, Inc. at 4 sites in Spain.
Trial summary
The purpose of this study is to collect real-world safety and performance data on the MIVI Neuroscience, Inc. Q Aspiration Catheter for use in the removal of fresh, soft emboli and thrombi in the neurovascular system during acute ischemic stroke. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- Q Aspiration Catheter
- Type of treatment
- Medical device
- How many people
- 45 participants
- Where
- 4 sitesSpain
- Study dates
- 16 Sep 2019to 23 Nov 2021
- Phase
- Observational
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
Study population: Population is patients diagnosed with large vessel occlusion acute ischemic stroke within 8 hours of stroke onset treated with mechanical aspiration thrombectomy with the Q Aspiration Catheter as first line therapy.
Who may be able to join
- Age 18 to 85 years;
- Diagnosis of acute ischemic stroke with mechanical thrombectomy procedure < 8 hours from onset of symptoms/ last known well;
- Large Vessel Occlusion on CT or MRI in the anterior cerebral vasculature up to A1, M1, or M2 or the posterior cerebral vasculature;
- ASPECTS 6 - 10 or volume of diffusion restriction < 50 mL;
- Use of the Q Aspiration Catheter as the first line treatment according to the IFU;
- Signed informed consent by patient or legally authorized representative.
Who cannot join
- Occlusions in multiple vascular territories, extracranial occlusion or tandem occlusion;
- Evidence of dissection in the carotid or target artery for treatment;
- Evidence of recent/fresh haemorrhage on presentation;
- Unwilling to agree to a 3-month follow up visit.
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Hospital Universitario 12 De Octubre
Madrid
Hospital Virgen de la Arrixaca
Murcia
Centro Hospitalario Universitario Donostia
San Sebastián
Hospital Universitario de Santiago de Compostela
Santiago de Compostela
About this study
Official title: An Observational Study of the Q Aspiration Catheter Used During Neurointervention for Acute Large Vessel Ischemic Stroke in Spain.
The purpose of this study is to collect real-world safety and performance data on the MIVI Neuroscience, Inc. Q Aspiration Catheter for use in the removal of fresh, soft emboli and thrombi in the neurovascular system during acute ischemic stroke.
Read the detailed description
The purpose of this study is to demonstrate the safety and performance of the MIVI Neuroscience, Inc. CE Marked Q Aspiration Catheter for use in the removal of fresh, soft emboli and thrombi in the neurovascular system during acute ischemic stroke. The study is an observational study collecting Q Aspiration Catheter use that will enroll a maximum of 50 subjects at a maximum of 5 sites in Spain. Subjects data will be collected through hospitalization with a 3 months post-procedure study visit. This study is designed for observational data to be collected and reported.
- Conditions
- Stroke, Ischemic
- Being tested
- Q Aspiration Catheter
- Keywords
- Mechanical thrombectomy, Acute ischemic stroke, neurovascular intervention
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Q Aspiration CatheterDevice
The Q Aspiration Catheter is indicated for use in the removal of fresh, soft emboli and thrombi in the neurovascular system.
| Study group | Role | What they receive |
|---|---|---|
| Q Aspiration Catheter | mechanical thrombectomy for acute ischemic stroke Receives: Device: Q Aspiration Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Revascularization Rate
Defined as final modified Thrombolysis In Cerebral Infarction scale (mTICI 2b-3) flow in the target vessel
Measured: intra-procedural
Symptomatic Intracranial Haemorrhage Rate
Defined as the symptomatic intracranial haemorrhage as detected by CT/MRI with an NIHSS change of >/= 4 points
Measured: 24 hours post procedure
Secondary outcomes (4)
Successful Revascularization Rate Using the Q Aspiration Catheter as the Only Thrombectomy Device
Defined as mTICI 2b-3 flow in the target vessel post-treatment with the Q Catheter (first line therapy)
Measured: intra-procedural
Rate of Embolization to a New Neurovascular Territory (ENT)
As measured by independent Angiographic Core Lab
Measured: intra-procedural
Good Functional Outcome Measured by Modified Rankin Scale Score of 0-2
The Modified Rankin Scale (mRS) measures neurological disability or dependence for stroke patients on a scale of 0 (no symptoms) to 6 (deceased).
Measured: 90 days
Mortality Rate
Rate of all cause mortality
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 posted13 Sep 2019
- Study start16 Sep 2019
- Primary completion30 Mar 2021
- Study completion23 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke, IschemicStudies 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
- Retrospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- MIVI Neuroscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mariano Espinosa de Rueda Ruiz, MD, Principal investigator, Neurorradiologia Intervencionista, HCUVA, Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04089917
- Sponsor's protocol ID
- 101347
- Acronym
- TAPAS
- Status last verified
- Oct 2022
- First submitted
- 21 Aug 2019
- Last updated
- 7 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Espinosa de Rueda M, Ballenilla Marco F, Garmendia Lopetegui E, Pumar JM, Zamarro J, Garcia-Villalba B, Diaz-Perez J, Mosqueira A, Luttich A, Larrea JA, Parrilla G. Thrombectomy aspiration post-market study in acute stroke with the Q aspiration catheter: the TAPAS study. J Neurointerv Surg. 2023 Jul;15(7):674-678. doi: 10.1136/neurintsurg-2022-018649. Epub 2022 May 31.
PubMed 35641183