Trials Sponsors Conditions Drugs Pricing

Conditions

Acute Ischemic Stroke

Keywords

StrokeIschemiaThromboaspiration

Outcome Measures

Primary Outcomes (3)

Performance success
Recanalization rate with mTICI ≥2b-3 (modified thrombolysis in cerebral infarction scale).
In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure.
MAE
All serious adverse events.
24 hours (-8/+12 hours)
Mortality
All-cause mortality.
90 days

Secondary Outcomes (13)

Navigability
In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure.
Clinical progress
90 days
Proportion of patients with rapid neurological improvement
24 hours
Reduction of NIHSS scale
24 or 72 hours
Procedure duration
In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure.
+8 more secondary outcomes

Study Arms (1)

Experimental: iNstroke

Study device

Device: iNstroke

Interventions

iNstrokeDevice

Patients to undergo thromboaspiration with iNstroke.

Experimental: iNstroke

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

All consecutive patients experiencing acute ischaemic stroke of the anterior circulation with occlusion of TICA, M1, extracranial ICA, vertebral artery segment V4 or basilar artery, treated with iNstroke aspiration catheter and complying with the eligibility criteria.

You may qualify if:

Patients with acute ischaemic stroke over 18 years of age caused by large vessel occlusion (TICA, extracranial ICA, M1, vertebral artery segment V4 or basilar artery) and receiving neurointerventional treatment with the iNstroke aspiration catheter.

Sponsors & Collaborators

iVascular S.L.U.
Industrylead

Study Sites (1)

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

MeSH Terms

Conditions

Ischemic StrokeStrokeIschemia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Enrollment

113 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: CASE ONLY
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 21, 2022

First Posted

February 9, 2023

Study Start

December 26, 2022

Actual (reported)

Efficacy and Safety Evaluation of the Thromboaspiration Catheter System iNstroke in Patients With Acute Ischemic Stroke

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (13)

Study Arms (1)

Experimental: iNstroke

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (13)

Study Arms (1)

Experimental: iNstroke

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations