Efficacy and Safety Evaluation of iNstroke 5F Aspiration Catheter for Thrombectomy (NCT07571954) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Efficacy and Safety Evaluation of iNstroke 5F Aspiration Catheter for Thrombectomy
France, Spain45 participantsStarted 2026-08-31
Plain-language summary
Prospective, single-arm, multi-centre study to evaluate the efficacy and safety of the iNstroke 5F thromboaspiration catheter in patients with acute ischaemic stroke
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects aged ≥ 18 years.
* Subjects able to be treated (i.e., defined by groin puncture time) within 24 hours of symptom onset or last time seen well.
* Occlusion in a large or proximal medium vessel (M1, proximal M2, A2 or P2) identified by magnetic resonance angiography (MRA) or computed tomography angiography (CTA).
* Baseline NIHSS score ≥ 6 assessed before the procedure.
* Pre-stroke mRS score ≤ 2.
* Subjects with an ASPECTS score ≥ 6.
* Informed consent obtained in accordance with the applicable country-specific regulations and as approved by the Ethics Committee (EC).
* France-specific inclusion criteria: As applicable under French law, subjects affiliated with a health social security scheme or equivalent.
Exclusion Criteria:
* 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.
* Severe allergy to contrast media.
* Women of child-bearing potential.
* Subjects with intracranial atherosclerotic occlusive disease or extra- or intracranial dissection.
* Medical history of thrombocytopenia (Platelets \<100,000).
* Subjects with tandem occlusions (evidence of complete occlusion, high-grade stenosis or arterial dissection in the extracranial or petrous segment of the internal carotid artery).
* Subjects with occlusions in multiple vessels.
* Subjects with cancer who have a life expectancy of less than 6 months.
* Pre-existing neurolo…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.