Evaluation of iNstroke Aspiration Catheters for Thrombectomy: a Multi-center Prospective Study (iNDUO)

iVascular

Status: Begins enrollment in 3 months

Conditions: Acute Ischemic Stroke

Treatments: Device: Thromboaspiration catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT07376447

iNDUO-01

Details and patient eligibility

About

Prospective, single-arm, multi-center study to confirm the performance and safety of the iNstroke 6F and 4F thromboaspiration catheter for the treatment of acute ischemic stroke

Full description

This clinical investigation has been designed to generate further data demonstrating the safety and effectiveness of the iNstroke device as well as of the thrombectomy process for the treatment of large and medium vessel occlusions.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients ≥ 18 years of age.
2. Able to be treated (i.e., defined by arterial puncture time) within 24 hours of symptom onset or last time seen well (LTSW).
3. Demonstrated occlusion in a large and/or medium vessel (carotid T, M1, proximal M2, M2-M3, A1, A2, A3, basilar artery, P1, P2, P3).
4. Baseline NIHSS score ≥6 assessed before the procedure.
5. Pre-morbid [xB13.1]stroke baseline mRS ≤ 2.
6. Subjects with an ASPECTS ≥ 6.
7. Informed consent signed by the subject or their representative, or notice of information, as per regulatory requirements, to collect the subject's data.
8. As applicable by French laws, the subject is affiliated to a health social security regimen or equivalent (only to be answered by French sites).

Exclusion criteria

1. Severe comorbidity and/or shortened life expectancy that will likely prevent improvement or follow up or that will render the procedure unlikely to benefit the patient.
2. Severe allergy to contrast media.
3. As applicable by French laws: breastfeeding women, persons deprived of their liberty by a judicial or administrative decision, or persons of full age who are the subject of a legal protection measure.
4. Patients with intracranial atherosclerotic occlusive disease or extra- or intracranial dissection.
5. Multiple Intracranial Occlusions
6. Known medical history of thrombocytopenia (Platelets <100,000).
7. Presence of intracerebral hemorrhage.
8. Significant mass effect and/or midline shift.
9. Evidence of intracranial tumor (except small meningioma).
10. Intracranial stenosis proximal to the occlusion.
11. Severe sustained hypertension (systolic pressure >185 mm Hg or diastolic pressure >110 mm Hg). Note: If blood pressure can be successfully reduced and maintained at an acceptable level by administering the medication recommended by the ESO (European Stroke Organisation) in its guidelines (also IV infusion of antihypertensives), the patient may be included.
12. Known or suspected cerebral vasculitis.
13. Known renal insufficiency with creatinine ≥3 mg/dl or Glomerular Filtration Rate (GFR) <30 mL/min.
14. Current participation in an interventional drug or device study that may confound the results of this study.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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160 participants in 1 patient group

Thromboaspiration using iNstroke 4F and/or iNstroke 6F aspiration catheter

Other group

Description:

No comparator will be used in this clinical investigation as it is an exploratory study of a CE-marked medical device to be used within the scope of its intended purpose.

Treatment:

Device: Thromboaspiration catheter