Evaluation of iNstroke 5F Aspiration Catheters for Thrombectomy: a Multi-center Prospective Study

NCT07571954 | Not Yet Recruiting

• 1 other identifier: iNFLOW-5
• Study Type: interventional
• Target: 45
• Locations: 2 countries
• Sites: 7

Brief 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

Conditions

Acute Ischemic Stroke

Keywords

Stroke; Thromboaspiration; Ischemia

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 5F aspiration catheter

OTHER

No comparator will be used as this is a traditional feasibility clinical investigation. The objective is to capture preliminary clinical performance, effectiveness and safety information to adequately plan an appropriate pivotal clinical investigation.

Device: Thromboaspiration catheter

Interventions

Thromboaspiration catheter DEVICE

Patients to undergo thromboaspiration with iNstroke 5F

Thromboaspiration using iNstroke 5F aspiration catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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).
• \. As applicable under French law, subjects affiliated with a health social security scheme or equivalent.

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. 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. Pre-existing neurological or psychiatric illness. 10.
• 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 subject may be included. 11. Known or suspected cerebral vasculitis. 12. Known renal insufficiency with creatinine ≥3 mg/dl or Glomerular Filtration Rate (GFR) \<30 mL/min. 13. Current participation in an interventional drug or device study that may confound the results of this study. 14. Intracranial stenosis proximal to the occlusion.
• \. As applicable under French law, breastfeeding women, persons deprived of their liberty by a judicial or administrative decision, or persons of legal age who are the subject of a legal protection measure.

Sponsors & Collaborators

• iVascular S.L.U.: lead

Study Sites (7)

CHU Bordeaux (H Pellegrin)

Bordeaux, France

Location

CHU Lille

Lille, France

Location

Hospital Regional Universitario de Málaga Carlos Haya

Málaga, Andalusia, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, Aragon, Spain

Location

Hospital Clínico de Barcelona

Barcelona, Barcelona, Spain

Location

Hospital Universitario Bellvitge

L'Hospitalet de Llobregat, Catalonia, Spain

Location

Hospital Álvaro Cunqueiro

Vigo, Galicia, Spain

Location

MeSH Terms

Conditions

Ischemic Stroke; Stroke; Ischemia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological 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: April 30, 2026
• First Posted: May 7, 2026
• Study Start (Estimated): August 31, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: May 7, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (5); FR (2)