Evaluation of iNstroke 5F Aspiration Catheters for Thrombectomy: a Multi-center Prospective Study (NCT07571954) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Evaluation of iNstroke 5F Aspiration Catheters for Thrombectomy: a Multi-center Prospective Study
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 range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
1\. Subjects aged ≥ 18 years. 2. Subjects able to be treated (i.e. defined by groin puncture time) within 24 hours of symptom onset or last time seen well. 3. 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). 4. Baseline NIHSS score ≥ 6 assessed before the procedure. 5. Pre-stroke mRS score ≤ 2. 6. Subjects with an ASPECTS score ≥ 6. 7. Informed consent obtained in accordance with the applicable country-specific regulations and as approved by the Ethics Committee (EC).
France-specific inclusion criteria:
1\. As applicable under French law, subjects affiliated with a health social security scheme or equivalent.
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. Women of child-bearing potential. 4. Subjects with intracranial atherosclerotic occlusive disease or extra- or intracranial dissection. 5. Medical history of thrombocytopenia (Platelets \<100,000). 6. 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). 7. Subjects with occlusions in multiple vessels. 8. Subjects with cancer who have a life expectancy of less than 6 months. 9.…