Prospective, Multicentre Study to Evaluate the Thrombectomy System for Stroke: iNedit, iNdeep and iNtercept

NCT05893719 | Completed

• 1 other identifier: SEMTiC-01
• Study Type: observational
• Target: 175
• Locations: 3 countries
• Sites: 18

Brief Summary

First prospective, single-arm, multicentre study to evaluate the safety and efficacy of the overall stroke thrombectomy system: iNedit, iNdeep and iNtercept in patients with acute ischemic stroke.

Conditions

Acute Ischemic Stroke

Keywords

Stroke; Mechanical Neurothrombectomy; Ischemia

Outcome Measures

Primary Outcomes (3)

• Performance Success

  To assess the ability of the system to successfully perform a neurothrombectomy using the three devices to be evaluated and with ≤3 insertions (passes) of the stent retriever.

  In the course of endovascular procedure, evaluated immediately after it.

• MAE

  All serious adverse events following the intervention or until an alternative stroke treatment is started, whichever occurs first.

  24 hours (-8/+12 hours)

• Mortality

  All-cause mortality

  90 days

Secondary Outcomes (13)

• Clinical progress

  90 days

• Proportion of patients with rapid neurological improvement

  24 hours after treatment

• Reduction of NIHSS scale

  At 72 hours or at the time of discharge, whichever occurs first.

• Procedure duration

  In the course of endovascular procedure, evaluated immediately after it.

• Number of passes with the device until recanalization.

  In the course of endovascular procedure, evaluated immediately after it.

Study Arms (1)

Experimental: iNedit, iNdeep, iNtercept

Study devices

Device: iNedit, iNdeep, iNtercept

Interventions

iNedit, iNdeep, iNtercept DEVICE

Patients to undergo mechanical thrombectomy with iNedit, iNdeep and iNtercept

Experimental: iNedit, iNdeep, iNtercept

Eligibility Criteria

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

Study Population

Patients who present acute stroke, attributable to occlusion of the internal carotid artery, M1 or M2 segments of the middle cerebral artery, and who are not suitable to receive IV rtPA or who have already received IV rtPA treatment without sufficient recanalization, within 24 hours from symptoms onset (or the last time they were seen well) to groin puncture in the catheterisation laboratory.

You may qualify if:

• Clinical:
• Age ≥18
• Informed consent signed by the patient or their representative; to use the patient's data
• Focal disabling neurologic deficit consistent with acute cerebral ischemia.
• Baseline NIHSS obtained before procedure of ≥6 points and ≤25 points.
• Pre-stroke mRS score ≤2.
• Planning to start treatment within 24 hours of symptoms onset, defined as the last time when the patient was seen well (the start of the procedure is defined as arterial puncture).
• Neuroimaging criteria:
• Occlusion (TICI 0 or TICI 1) of the internal intracranial carotid artery, M1 and M2 segments of the middle cerebral artery and T carotid artery, suitable for mechanical thrombectomy confirmed by conventional angiography.
• For patients treated ≤8 hours:
• a) Score 6 to 10 on ASPECTS scale (Alberta Stroke Program Early CT Score).
• For patients treated between 8 and 24 hours:
• a) "Target Mismatch Profile" on CT perfusion or MRI (ischemic core volume is \<70mL, mismatch ratio is \>1,8 and mismatch volume is \>15 mL).
• Ability to obtain selective angiography by catheterisation of the target artery.

You may not qualify if:

• Clinical:
• Patient has suffered a stroke in the past one year.
• Occlusion (TICI 0 or TICI 1) in vertebrobasilar territory.
• Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories.
• Known hemorrhagic diathesis, coagulaion factor deficiency or oral anti-vitamin K anticoagulant therapy with an INR \>3.0.
• Blood glucose \<50 mg/dl or \>400 mg/dl. NOTE: If blood glucose can be successfully reduced and maintained at an acceptable level by administering the medication recommended by the ESO (European Stroke Organisation) in its guidelines, the patient may be included.
• 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.
• Serious advanced or terminal illness with anticipated life expectancy of less than six months.
• History of life-threatening allergy (more than rash) to contrast medium.
• Known allergy to nickel, prior to treatment.
• Known renal insufficiency with creatinine ≥3 mg/dl or Glomerular Filtration Rate (GFR) \<30 mL/min.
• Cerebral vasculitis.
• Known current cocaine use.
• Patients who are unlikely to be available for 90-day follow-up (e.g. no fixed home address, visitors from overseas).
• Neuroimaging criteria:

Sponsors & Collaborators

• iVascular S.L.U.: lead

Study Sites (18)

Hospital AZ Groeninge

Kortrijk, Belgium

Location

Hospital Klinikum Ludwigsburg

Ludwigsburg, 71640, Germany

Location

Hospital LMU Klinikum

Munich, 80336, Germany

Location

Hospital Klinikum Nürnberg

Nuremberg, 90471, Germany

Location

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 33011, Spain

Location

Hospital General Universitario de Alicante

Alicante, 03010, Spain

Location

Hospital Universitario de Badajoz

Badajoz, 06080, Spain

Location

Hospital de Cruces

Barakaldo, 48903, Spain

Location

Hospital de la Vall d'Hebrón

Barcelona, 08035, Spain

Location

Hospital Clinic i Provincial de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario de Bellvitge

Barcelona, 08907, Spain

Location

Hospital GermansTrias i Pujol

Barcelona, 08916, Spain

Location

Hospital Reina Sofia de Córdoba

Córdoba, 14004, Spain

Location

Hospital Insular de Gran Canaria

Las Palmas de Gran Canaria, 35016, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Hospital Clínico de Valencia

Valencia, 46010, Spain

Location

Hospital La Fe

Valencia, 46026, Spain

Location

Related Publications (2)

• San Roman L, Gramegna LL, Pich S, Domingo-Rodriguez L, Duran M, Duocastella L, Macho J. First prospective, single-arm, multicenter study to evaluate safety and efficacy of the overall thrombectomy system -iNedit, iNdeep, and iNtercept- for acute ischemic stroke. Rationale beyond the study. Front Neurol. 2025 Mar 5;16:1537008. doi: 10.3389/fneur.2025.1537008. eCollection 2025.

  PMID: 40134692 RESULT

• Tomasello A, Gramegna LL, Vega P, Castano C, Moreu M, Dominguez C, Macho J. Mechanical thrombectomy with a new intermediate balloon catheter combining the BGC and DAC features: Initial clinical experience with the iNedit device. Interv Neuroradiol. 2023 Oct 17:15910199231207407. doi: 10.1177/15910199231207407. Online ahead of print.

  PMID: 37847747 RESULT

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: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2022
• First Posted: June 8, 2023
• Study Start: July 29, 2022
• Primary Completion: August 17, 2024
• Study Completion: February 25, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (14); BE (1); DE (3)