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

Stroke, Ischemic Clinical Trial

— TAPAS  

Official title:

An Observational Study of the Q Aspiration Catheter Used During Neurointervention for Acute Large Vessel Ischemic Stroke in Spain.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04089917
• Other study ID #: 101347
• Status: Completed
• Start date: September 16, 2019
• Est. completion date: November 23, 2021

Study information

• Verified date: October 2022
• Source: MIVI Neuroscience, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: November 23, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Stroke
• Stroke, Ischemic

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital Universitario 12 De Octubre	Madrid
Spain	Hospital Virgen de la Arrixaca	Murcia
Spain	Centro Hospitalario Universitario Donostia	San Sebastián
Spain	Hospital Universitario de Santiago de Compostela	Santiago De Compostela

Sponsors (1)

Lead Sponsor	Collaborator
MIVI Neuroscience, Inc.

Country where clinical trial is conducted

Spain, 

References & 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: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful Revascularization Rate	Defined as final modified Thrombolysis In Cerebral Infarction scale (mTICI 2b-3) flow in the target vessel	intra-procedural
Primary	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	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)	intra-procedural
Secondary	Rate of Embolization to a New Neurovascular Territory (ENT)	As measured by independent Angiographic Core Lab	intra-procedural
Secondary	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).	90 days
Secondary	Mortality Rate	Rate of all cause mortality	90 days

External Links

•   Thrombectomy aspiration post-market study in acute stroke with the Q aspiration catheter: the TAPAS study