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

NCT05720975 | Completed

• 1 other identifier: ASPiC-01
• Study Type: observational
• Target: 113
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Ischemic Stroke

Keywords

Stroke; Ischemia; Thromboaspiration

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.

Study Arms (1)

Experimental: iNstroke

Study device

Device: iNstroke

Interventions

iNstroke DEVICE

Patients to undergo thromboaspiration with iNstroke.

Experimental: iNstroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-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.
• Informed consent signed by the patient or their representative, or deferred informed consent to avoid delaying commencement of mechanical thrombectomy.
• Patients with an ASPECTS (Alberta Stroke Program Early CT Score) score ≥ 6
• In patients having onset of stroke more than 8 hours previously, wake-up strokes, or unknown time of onset, treatment must be customised and CT perfusion must show penumbra.
• Initial NIHSS score before procedure \> 6.

You may not qualify if:

• Patients under 18 years of age.
• Patients with an ASPECTS score \<6.
• Baseline NIHSS obtained before procedure of ≤ 6 points.
• Severe comorbidity and/or shortened life expectancy
• mRS \> 2.
• Serious allergy to contrast medium.
• Pregnant women.
• Patients with intracranial atherosclerotic occlusive disease or extra- or intracranial dissection
• Personal history of thrombocytopaenia (\<40,000 platelets)

Sponsors & Collaborators

• iVascular S.L.U.: lead

Study Sites (1)

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

Location

MeSH Terms

Conditions

Ischemic Stroke; Stroke; Ischemia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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
• Primary Completion: January 7, 2025
• Study Completion: January 7, 2025
• Last Updated: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)