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

Acute Ischemic Stroke Clinical Trial

— ASPiC  

Official title:

First Prospective, Single-arm, Single-centre Study to Evaluate the Efficacy and Safety of the Thromboaspiration Catheter System (iNstroke) for Stroke in Patients With Acute Ischemic Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05720975
• Other study ID #: ASPiC-01
• Status: Recruiting
• Start date: December 26, 2022
• Est. completion date: January 2024

Study information

• Verified date: January 2023
• Source: iVascular S.L.U.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

First prospective, single-arm, single-centre study to evaluate the efficacy and safety of the iNstroke thromboaspiration catheter system (iNstroke) for stroke in patients with acute ischemic stroke.

Description:

This is a prospective, single-arm, single-centre clinical safety and efficacy research. The purpose of the study is to evaluate safety and efficacy the device designed by iVascular for thromboaspiration (iNstroke) in patients who have suffered a stroke and who undergo thromboaspiration due to an acute occlusion of neuro vessels.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 95
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients with acute ischaemic stroke over 18 years of age caused by large vessel occlusion and receiving neurointerventional treatment with the iNstroke aspiration catheter.

2. Informed consent signed by the patient or their representative.

3. Patients with an ASPECTS (Alberta Stroke Program Early CT Score) score = 6 and occlusion of a large vessel (TICA, M1, and tandem with TICA or M1 occlusion, vertebral or basilar).

4. In those patients with more than 8 hours of symptom onset or with stroke on awakening or unknown onset stroke, treatment should be individualised and there should be a penumbra area in CT perfusion.

5. Baseline NIHSS obtained before procedure of =6 points.

Exclusion Criteria:

1. Patients under 18 years of age.

2. Patients with an ASPECTS score <6.

3. Baseline NIHSS obtained before procedure of = 6 points.

4. Severe comorbidity and/or shortened life expectancy

5. ERm >2.

6. Severe allergy to contrast media.

7. Pregnant women.

8. Patients with intracranial atherosclerotic occlusive disease or extra- or intracranial dissection

9. Medical history of plateletopenia (Platelets <100,000)

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Device:
• iNstroke
Patients to undergo thromboaspiration with iNstroke.

Locations

Country	Name	City	State
Spain	Hospital Universitario Virgen del Rocío	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
iVascular S.L.U.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	MAE	All serious adverse events.	24 hours (-8/+12 hours)
Primary	Mortality	All-cause mortality.	90 days
Secondary	Navigability	Number of procedures in which the InStroke catheter reaches the intracranial occluded segment (M1, basilar artery) through coaxial system with a microcatheter and without the assistance of other additional devices.	In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure.
Secondary	Clinical progress	Good functional clinical progress (modified Rankin scale 0-2).	90 days
Secondary	Proportion of patients with rapid neurological improvement	Proportion of patients with rapid neurological improvement (more than 4 points on the NIHSS scale)	24 hours
Secondary	Reduction of NIHSS scale	Proportion of patients with a reduction of =8 points on the NIHSS scale (during the first 24 hours post-treatment), or NIHSS 0-1 (at 72 hours [or at the time of discharge, whichever occurs first]).	24 or 72 hours
Secondary	Procedure duration	Procedure duration defined as the time from puncture to when grade =2b is reached on the mTICI scale with less than three passes or, if not achieved, until the final angiogram.	In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure.
Secondary	Number of passes with the device until recanalisation.	Number of passes with the device until recanalisation.	In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure.
Secondary	Percentage of effective recanalisation in a first pass	Percentage of effective recanalisation in a first pass, the effect of which will be measured by a recanalisation rate of TICI2c-3 and TICI 2b-3.	In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure.
Secondary	Rate of need to use another reperfusion technique	Rate of need to use another reperfusion technique due to suction system failure.	In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure.
Secondary	Assessment of symptomatic intracerebral haemorrhage	Assessment of symptomatic intracerebral haemorrhage by magnetic resonance imaging (MRI)/computed tomography (CT). ICH is defined as the presence of extravascular blood in the brain or within the skull- ICH is considered symptomatic (SICH) if it is associated with clinical deterioration (worsening of the score National Institutes of Health Stroke Scale (NIHSS) of; =4 points) or if it causes death and is identified as the predominant cause of neurological deterioration, according to the assessment of an independent clinical events committee (CEC).	24 (-8/+12) hours.
Secondary	Neurological deterioration	Classification of neurological deterioration of =4 points on the NIHSS scale.	24 (-8/+12) hours.
Secondary	Embolization rate	Embolization rate in a previously non-involved territory on cerebral angiography.	In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure.
Secondary	Mortality rate	Mortality rate related to the procedure	3 days (+/-24 hours) or at discharge, whichever occurs first.
Secondary	Procedure complication rate	Procedure complication rate: arterial perforation, arterial dissection and severe vasospasm in the target vessel	In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure.