A Study of the Use of the Q Aspiration Catheter to Remove Clot in Stroke Patients (TAPAS)

October 28, 2022 updated by: MIVI Neuroscience, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain
        • Hospital Universitario 12 de Octubre
      • Murcia, Spain
        • Hospital Virgen de la Arrixaca
      • San Sebastián, Spain
        • Centro Hospitalario Universitario Donostia
      • Santiago De Compostela, Spain
        • Hospital Universitario de Santiago de Compostela

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability 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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Q Aspiration Catheter
mechanical thrombectomy for acute ischemic stroke
Device: Q Aspiration Catheter
The Q Aspiration Catheter is indicated for use in the removal of fresh, soft emboli and thrombi in the neurovascular system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful Revascularization Rate
Time Frame: intra-procedural
Defined as final modified Thrombolysis In Cerebral Infarction scale (mTICI 2b-3) flow in the target vessel
intra-procedural
Symptomatic Intracranial Haemorrhage Rate
Time Frame: 24 hours post procedure
Defined as the symptomatic intracranial haemorrhage as detected by CT/MRI with an NIHSS change of >/= 4 points
24 hours post procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful Revascularization Rate Using the Q Aspiration Catheter as the Only Thrombectomy Device
Time Frame: intra-procedural
Defined as mTICI 2b-3 flow in the target vessel post-treatment with the Q Catheter (first line therapy)
intra-procedural
Rate of Embolization to a New Neurovascular Territory (ENT)
Time Frame: intra-procedural
As measured by independent Angiographic Core Lab
intra-procedural
Good Functional Outcome Measured by Modified Rankin Scale Score of 0-2
Time Frame: 90 days
The Modified Rankin Scale (mRS) measures neurological disability or dependence for stroke patients on a scale of 0 (no symptoms) to 6 (deceased).
90 days
Mortality Rate
Time Frame: 90 days
Rate of all cause mortality
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MIVI Neuroscience, Inc.

Investigators

  • Principal Investigator: Mariano Espinosa de Rueda Ruiz, MD, Neurorradiologia Intervencionista, HCUVA, Murcia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2019

Primary Completion (Actual)

March 30, 2021

Study Completion (Actual)

November 23, 2021

Study Registration Dates

First Submitted

August 21, 2019

First Submitted That Met QC Criteria

September 12, 2019

First Posted (Actual)

September 13, 2019

Study Record Updates

Last Update Posted (Actual)

September 7, 2023

Last Update Submitted That Met QC Criteria

October 28, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 101347

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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