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Not yet recruiting NCT07376447

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

No phase Interventional Acute Ischemic Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Thromboaspiration catheter.
Who it may be relevant to
Registry conditions: Acute Ischemic Stroke. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France, Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Confirmation of the Performance and Safety of the iNstroke 6F and 4F Thromboaspiration Catheter for the Treatment of Acute Ischemic Stroke

Overview

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

Detailed 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.

Interventions

  • Device Thromboaspiration catheter
    Patients to undergo thromboaspiration with iNstroke 6F and/or 4F

Primary outcome measures

  • Recanalization Rate [Time frame: Intra-procedure]

Eligibility criteria

Inclusion criteria

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

  • 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.
  • 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.
  • Patients with intracranial atherosclerotic occlusive disease or extra- or intracranial dissection.
  • Multiple Intracranial Occlusions
  • Known medical history of thrombocytopenia (Platelets <100,000).
  • Presence of intracerebral hemorrhage.
  • Significant mass effect and/or midline shift.
  • Evidence of intracranial tumor (except small meningioma).
  • Intracranial stenosis proximal to the occlusion.
  • 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.
  • Known or suspected cerebral vasculitis.
  • Known renal insufficiency with creatinine ≥3 mg/dl or Glomerular Filtration Rate (GFR) <30 mL/min.
  • Current participation in an interventional drug or device study that may confound the results of this study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

France · 6 centers
  • CHU Bordeaux (H Pellegrin) — Bordeaux
  • CHU Brest — Brest
  • CHU Lille — Lille
  • CHU Nancy — Nancy
  • APHP Pitié Salpétrière — Paris
  • CHU Strasbourg — Strasbourg
Germany · 5 centers
  • Klinikum Bremen Mitte — Bremen
  • Universität zu Köln — Cologne
  • Knappschaft Kliniken — Dortmund
  • UKE Hamburg — Hamburg
  • Klinikum Nürnberg — Nuremberg

Identifiers

NCT: NCT07376447 · iNDUO-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗