NCT04089917: TAPAS

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

Completed Results posted Last updated 7 September 2023

What this trial tests

trial testing Q Aspiration Catheter in Stroke, Ischemic in 45 participants. Completed in 23 November 2021.

Timeline

16 September 2019

Primary endpoint
30 March 2021

23 November 2021

Quick facts

Lead sponsor	MIVI Neuroscience, Inc.
Status	Completed
Study type	OBSERVATIONAL
Enrollment	45
Start date	16 September 2019
Primary completion	30 March 2021
Estimated completion	23 November 2021
Sites	4 locations across Spain

Drugs / interventions tested

• Q Aspiration Catheter

Conditions studied

• Stroke, Ischemic — all drugs for Stroke, Ischemic →

Sponsor

MIVI Neuroscience, Inc.

Who can join

Adults 18 to 85, any sex, with Stroke, Ischemic. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Successful Revascularization Rate Primary · intra-procedural

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

Group	Value	95% CI
Q Aspiration Catheter	42

Symptomatic Intracranial Haemorrhage Rate Primary · 24 hours post procedure

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

Group	Value	95% CI
Q Aspiration Catheter	1

Successful Revascularization Rate Using the Q Aspiration Catheter as the Only Thrombectomy Device Secondary · intra-procedural

Defined as mTICI 2b-3 flow in the target vessel post-treatment with the Q Catheter (first line therapy)

Group	Value	95% CI
Q Aspiration Catheter	25

Rate of Embolization to a New Neurovascular Territory (ENT) Secondary · intra-procedural

As measured by independent Angiographic Core Lab

Group	Value	95% CI
Q Aspiration Catheter	0

Good Functional Outcome Measured by Modified Rankin Scale Score of 0-2 Secondary · 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).

Group	Value	95% CI
Q Aspiration Catheter	25

Mortality Rate Secondary · 90 days

Rate of all cause mortality

Group	Value	95% CI
Q Aspiration Catheter	7

Adverse events — posted to ClinicalTrials.gov

Time frame: From procedure through subject 3 month follow up visit, serious adverse events were collected. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Q Aspiration Catheter

Serious: 11/45 (24%)

Deaths: 7/45

Serious adverse events (4 terms)

Reaction	System	Q Aspiration Catheter
Hemorrhagic transformation	General disorders	—
Death of unknown cause	General disorders	—
mechanical ventilation complications	Respiratory, thoracic and mediastinal disorders	—
Myocardial infarction	Cardiac disorders	—

Other adverse events (1 terms — click to expand)

Reaction	System	Q Aspiration Catheter
procedural complication	Injury, poisoning and procedural complications	—

Most-reported serious reactions: Hemorrhagic transformation, Death of unknown cause, mechanical ventilation complications, Myocardial infarction.

Data from ClinicalTrials.gov NCT04089917 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.