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

Completed

• Conditions: Acute Ischemic Stroke
• Interventions: Device: iNedit, iNdeep, iNtercept

• Registration Number: NCT05893719
• Lead Sponsor: iVascular S.L.U.

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.

Detailed Description

This is a prospective, multicentre, single-arm and open-label clinical safety and efficacy research.

The purpose of the study is to evaluate the safety and efficacy of the three devices designed by iVascular for neurothrombectomy (iNedit, iNdeep and iNtercept) used together as a tool to facilitate the placement of the stent retriever and apply temporary restriction of blood flow in patients who have suffered a stroke and who undergo mechanical thrombectomy due to acute large vessel occlusion (LVO), presented within 8 hours from symptoms onset (the last time the patient was seen well).

Being a mechanical thrombectomy the procedure by which the thrombus that occludes a cerebral vessel is accessed. It is accessed through an endovascular catheter, inserted through the femoral artery, for disruption or removal.

Study Timeline

• Study First Submitted: 2022-07-21
• Study Start: 2022-07-29
• Study First Submitted QC: 2023-05-29
• Study First Posted: 2023-06-08
• Primary Completion: 2024-08-17
• Study Completion: 2025-02-25
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

Clinical:

1. Age ≥18
2. Informed consent signed by the patient or their representative; to use the patient's data
3. Focal disabling neurologic deficit consistent with acute cerebral ischemia.
4. Baseline NIHSS obtained before procedure of ≥6 points and ≤25 points.
5. Pre-stroke mRS score ≤2.
6. 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:

1. 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.

2. 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).

3. Ability to obtain selective angiography by catheterisation of the target artery.

Exclusion Criteria

Clinical:

1. Patient has suffered a stroke in the past one year.
2. Occlusion (TICI 0 or TICI 1) in vertebrobasilar territory.
3. Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories.
4. Known hemorrhagic diathesis, coagulaion factor deficiency or oral anti-vitamin K anticoagulant therapy with an INR >3.0.
5. 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.
6. 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.
7. Serious advanced or terminal illness with anticipated life expectancy of less than six months.
8. History of life-threatening allergy (more than rash) to contrast medium.
9. Known allergy to nickel, prior to treatment.
10. Known renal insufficiency with creatinine ≥3 mg/dl or Glomerular Filtration Rate (GFR) <30 mL/min.
11. Cerebral vasculitis.
12. Known current cocaine use.
13. Patient who is participating, at the time of inclusion, in a study with a device or drug that could affect this study.
14. Patients who are unlikely to be available for 90-day follow-up (e.g. no fixed home address, visitors from overseas).

Neuroimaging criteria:

1. CT or MRI evidence of hemorrhage (the presence of microbleeds is allowed).
2. Significant mass effect with midline shift.
3. Evidence of complete occlusion, high-grade stenosis or arterial dissection in the extracranial or petrous segment of the internal carotid artery (TANDEM lesions).
4. Patients with known or suspected underlying intracranial atherosclerotic lesions responsible for the target occlusion.
5. Patients with occlusions in multiple vascular territories (e.g. bilateral anterior circulation or anterior/posterior circulation).
6. Evidence of intracranial tumour with the exception of asymptomatic meningiomas with no mass effect.
7. Presumed septic embolism with suspected aortic dissection or suspicion of bacterial endocarditis.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental: iNedit, iNdeep, iNtercept	iNedit, iNdeep, iNtercept	Study devices

Primary Outcome Measures

Name	Time	Method
Performance Success	In the course of endovascular procedure, evaluated immediately after it.	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.
MAE	24 hours (-8/+12 hours)	All serious adverse events following the intervention or until an alternative stroke treatment is started, whichever occurs first.
Mortality	90 days	All-cause mortality

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with rapid neurological improvement	24 hours after treatment	Proportion of patients with rapid neurological improvement (more than 4 points on the NIHSS scale, or NIHSS ≤4)
Reduction of NIHSS scale	At 72 hours or at the time of discharge, whichever occurs first.	Proportion of patients with a reduction of ≥8 points on the NIHSS scale or NIHSS 0-1
Clinical progress	90 days	Good functional clinical progress (modified Rankin scale 0-2)
Percentage of effective recanalization in a first pass.	In the course of endovascular procedure, evaluated immediately after it.	Percentage of effective recanalization in a first pass.
Assessment of intracranial haemorrhage (ICH)	24 (-8/+12) hours	Assessment of intracranial haemorrhage (ICH); any symptomatic or asymptomatic intracranial haemorrhage assessed by magnetic resonance imaging (MRI) /computed tomography (CT).
Procedure duration	In the course of endovascular procedure, evaluated immediately after it.	Procedure duration defined as the time from puncture to when grade ≥2b is reached on the mTICI scale with less than three passes or, if not achieved, until the final angiogram.
Rate of infarction in a previously non-involved vascular territory	24 hours.	Rate of infarction in a previously non-involved vascular territory, as evaluated by imaging (MRI/CT).
Rate of cases that reached the occlusion and allowed the performance of the trombectomy.	In the course of endovascular procedure, evaluated immediately after it.	Rate of cases where the microcatheter and the distal access balloon catheter reached the occlusion in the main vessel to allow navigation and deployment of the stent retriever to carry out the neurothrombectomy.
Neurological deterioration	24 (-8/+12) hours.	Classification of neurological deterioration of ≥4 points on the NIHSS scale
Embolization rate	In the course of endovascular procedure, evaluated immediately after it.	Embolization rate in a previously non-involved territory on cerebral angiography.
Number of passes with the device until recanalization.	In the course of endovascular procedure, evaluated immediately after it.	Number of passes with the device until recanalization.
Mortality rate	3 days (+/-24) hours	Mortality rate related to the procedure
Procedure complication rate	In the course of endovascular procedure, evaluated immediately after it.	Procedure complication rate: arterial perforation, arterial dissection and vasospasm in the target vessel and embolization in a previously non-involved vascular territory.

Trial Locations

Locations (18)

Hospital AZ Groeninge; 🇧🇪 Kortrijk, Belgium

Hospital Klinikum Nürnberg; 🇩🇪 Nürnberg, Germany

Hospital Klinikum Ludwigsburg; 🇩🇪 Ludwigsburg, Germany

Hospital LMU Klinikum; 🇩🇪 Munich, Germany

Hospital Universitario Central de Asturias; 🇪🇸 Oviedo, Asturias, Spain

Hospital Insular de Gran Canaria; 🇪🇸 Las Palmas De Gran Canaria, Spain

Hospital General Universitario Gregorio Marañón; 🇪🇸 Madrid, Spain

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain

Hospital Clínico de Valencia; 🇪🇸 Valencia, Spain

Hospital La Fe; 🇪🇸 Valencia, Spain

Hospital General Universitario de Alicante; 🇪🇸 Alicante, Spain

Hospital Universitario de Badajoz; 🇪🇸 Badajoz, Spain

Hospital de Cruces; 🇪🇸 Baracaldo, Spain

Hospital de la Vall d'Hebrón; 🇪🇸 Barcelona, Spain

Hospital Clinic i Provincial de Barcelona; 🇪🇸 Barcelona, Spain

Hospital Universitario de Bellvitge; 🇪🇸 Barcelona, Spain

Hospital GermansTrias i Pujol; 🇪🇸 Barcelona, Spain

Hospital Reina Sofia de Córdoba; 🇪🇸 Córdoba, Spain