NCT07376447

Brief Summary

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

Trial Health

67
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
18mo left

Started May 2026

Geographic Reach
2 countries

11 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
May 2026Dec 2027

First Submitted

Initial submission to the registry

January 22, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 29, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

May 31, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2027

Expected
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

February 2, 2026

Status Verified

January 1, 2026

Enrollment Period

9 months

First QC Date

January 22, 2026

Last Update Submit

January 29, 2026

Conditions

Acute Ischemic Stroke

Keywords

StrokeIschemiaThromboaspiration

Outcome Measures

Primary Outcomes (1)

  • Recanalization Rate

    Recanalization rate with mTICI ≥2b in ≤3 revascularization passes using iNstroke Thrombus Extraction Aspiration Device aspiration catheter alone, or in conjunction with Stent Retriever.

    Intra-procedure

Study Arms (1)

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

OTHER

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.

Device: Thromboaspiration catheter

Interventions

Thromboaspiration catheterDEVICE

Patients to undergo thromboaspiration with iNstroke 6F and/or 4F

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

CHU Bordeaux (H Pellegrin)

Bordeaux, France

Location

CHU Brest

Brest, France

Location

CHU Lille

Lille, France

Location

CHU Nancy

Nancy, France

Location

APHP Pitié Salpétrière

Paris, France

Location

CHU Strasbourg

Strasbourg, France

Location

Klinikum Bremen Mitte

Bremen, Germany

Location

Universität zu Köln

Cologne, Germany

Location

Knappschaft Kliniken

Dortmund, Germany

Location

UKE Hamburg

Hamburg, Germany

Location

Klinikum Nürnberg

Nuremberg, Germany

Location

MeSH Terms

Conditions

Ischemic StrokeStrokeIschemia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2026

First Posted

January 29, 2026

Study Start

May 31, 2026

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

February 2, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(5)FR(6)