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

iVascular

Status: Completed

Conditions: Acute Ischemic Stroke

Treatments: Device: iNstroke

Study type: Observational

Funder types: Industry

Identifiers

NCT05720975

ASPiC-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 113 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.
2. Informed consent signed by the patient or their representative, or deferred informed consent to avoid delaying commencement of mechanical thrombectomy.
3. Patients with an ASPECTS (Alberta Stroke Program Early CT Score) score ≥ 6
4. 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.
5. Initial NIHSS score before procedure > 6.

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. mRS > 2.
6. Serious allergy to contrast medium.
7. Pregnant women.
8. Patients with intracranial atherosclerotic occlusive disease or extra- or intracranial dissection
9. Personal history of thrombocytopaenia (<40,000 platelets)

Trial design

113 participants in 1 patient group

Experimental: iNstroke

Description:

Study device

Treatment:

Device: iNstroke