NCT04089917

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2019

Completed
23 days until next milestone

First Posted

Study publicly available on registry

September 13, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

September 16, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2021

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

September 7, 2023

Completed
Last Updated

September 7, 2023

Status Verified

October 1, 2022

Enrollment Period

1.5 years

First QC Date

August 21, 2019

Results QC Date

October 28, 2022

Last Update Submit

October 28, 2022

Conditions

Stroke, Ischemic

Keywords

Mechanical thrombectomyAcute ischemic strokeneurovascular intervention

Outcome Measures

Primary Outcomes (2)

  • Successful Revascularization Rate

    Defined as final modified Thrombolysis In Cerebral Infarction scale (mTICI 2b-3) flow in the target vessel

    intra-procedural

  • Symptomatic Intracranial Haemorrhage Rate

    Defined as the symptomatic intracranial haemorrhage as detected by CT/MRI with an NIHSS change of \>/= 4 points

    24 hours post procedure

Secondary Outcomes (4)

  • Successful Revascularization Rate Using the Q Aspiration Catheter as the Only Thrombectomy Device

    intra-procedural

  • Rate of Embolization to a New Neurovascular Territory (ENT)

    intra-procedural

  • Good Functional Outcome Measured by Modified Rankin Scale Score of 0-2

    90 days

  • Mortality Rate

    90 days

Study Arms (1)

Q Aspiration Catheter

mechanical thrombectomy for acute ischemic stroke

Device: Q Aspiration Catheter

Interventions

Q Aspiration CatheterDEVICE

The Q Aspiration Catheter is indicated for use in the removal of fresh, soft emboli and thrombi in the neurovascular system.

Q Aspiration Catheter

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hospital Universitario 12 De Octubre

Madrid, Spain

Location

Hospital Virgen de la Arrixaca

Murcia, Spain

Location

Centro Hospitalario Universitario Donostia

San Sebastián, Spain

Location

Hospital Universitario de Santiago de Compostela

Santiago de Compostela, Spain

Location

Related Publications (1)

  • 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.

    PMID: 35641183RESULT

Related Links

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Mariano Espinosa de Rueda
Organization
Department of Interventional Neuroradiology, Hospital Clínico Universitario Virgen de la Arrixaca, Murcia, Spain
mm.espinosa@gmail.com
+34 968 36 96 42

Study Officials

  • Mariano Espinosa de Rueda Ruiz, MD

    Neurorradiologia Intervencionista, HCUVA, Murcia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2019

First Posted

September 13, 2019

Study Start

September 16, 2019

Primary Completion

March 30, 2021

Study Completion

November 23, 2021

Last Updated

September 7, 2023

Results First Posted

September 7, 2023

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

ES(4)