Safety and Efficacy Evaluation of the iNstroke 4F Thromboaspiration Catheter in Patients With Acute Ischaemic Stroke Due to Primary Distal Medium Vessel Occlusions (DMVO)

Официальное название

Prospective, Single-arm, Multi-centre Study to Evaluate the Efficacy and Safety of the iNstroke 4F Thromboaspiration Catheter in Patients With Acute Ischaemic Stroke Due to Primary Distal Medium Vessel Occlusions (DMVO).

Обзор

Prospective, Single-arm, Multi-centre Study to Evaluate the Efficacy and Safety of the iNstroke 4F Thromboaspiration Catheter in Patients with Acute Ischaemic Stroke due to Primary Distal Medium Vessel Occlusions.

Подробное описание

This study is an exploratory, interventional, open label, single-arm, multi-centre prospective clinical investigation.

In this post-market clinical investigation, the aim is to further evaluate the efficacy and safety of the iNstroke 4F aspiration catheter, with a view to, in future clinical investigations, comparing the product with the standard therapy or with other similar products. In addition, this clinical investigation will generate results that could be used to further assess the safety and effectiveness of mechanical thrombectomy for the treatment of DMVO.

Вмешательства

• Устройство Thromboaspiration catheter
  Patients to undergo thromboaspiration with iNstroke 4F

Первичные конечные точки

• Recanalization Endpoint [Срок оценки: Intra-procedure]

Вторичные конечные точки (12)

• Recanalization Endpoint [Срок оценки: Intra-procedure]
• Recanalization Endpoint [Срок оценки: Intra-procedure]
• Recanalization Endpoint [Срок оценки: Intra-procedure]
• Recanalization Endpoint [Срок оценки: Intra-procedure]
• Recanalization Endpoint [Срок оценки: Intra-procedure]
• Clinical Endpoint [Срок оценки: 90 day]
• Safety Endpoint [Срок оценки: 24 (-8/+12) hours]
• Safety Endpoint [Срок оценки: Intra-procedure]
• Safety Endpoint [Срок оценки: Intra-procedure]
• Safety Endpoint [Срок оценки: During hospital admission]
• Safety Endpoint [Срок оценки: 90 days (±14 days) after the procedure.]
• Safety Endpoint [Срок оценки: Intra-procedure]

Критерии участия

Критерии включения

• Subjects aged ≥ 18 years.
• Subjects with symptom onset up to 24 hours.
• Isolated primary demonstrated occlusion in a distal medium vessel (Non-dominant or distal M2-MCA segment, M3 or M4 segments of MCA, A2-A3 segments of ACA, P1, P2 and P3 segments of PCA) identified by magnetic resonance angiography (MRA) or computed tomography angiography (CTA).
• Baseline NIHSS score ≥5 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).

Критерии исключения

• Subjects aged < 18.
• Suspected secondary DMVO. Suspicion or evidence of primary LVO whether it has been treated or not with fibrinolytic therapy or mechanical thrombectomy that subsequently develops a DMVO.
• Baseline NIHSS score <5 assessed before the procedure.
• Pre-stroke mRS score >2.
• Subjects with an ASPECTS score <6.
• 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.
• 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 (e.g., MCA-M3 and ACA-A2), whether or not they undergo mechanical thrombectomy.
• Subjects with cancer (with or without metastases) who have a life expectancy of less than 6 months.
• Subjects participating in a clinical trial at the moment of the inclusion.
• Subjects with pre-existing neurological or psychiatric illness that could confound the neurological or functional assessments.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Германия · 5 центров

• Universitätsklinikum Bonn — Bonn
• Universitätsklinikum Schleswig-Holstein — Kiel
• Klinikum Marburg — Marburg
• Klinikum Nürnberg — Nuremberg
• Knappschaftskrankenhaus Recklinghausen — Recklinghausen

Испания · 5 центров

• Hospital Universitario Vall d'Hebron — Barcelona
• Hospital Universitario 12 de Octubre — Madrid
• Hospital Universitario de Getafe — Madrid
• Hospital Universitario La Paz — Madrid
• Hospital Clínico Universitario Virgen de Arrixaca — Murcia

Венгрия · 1 центр

• Semmelweis University Center — Budapest

Идентификаторы

NCT: NCT07357285 · 4-NiVO-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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