Clinical trial NCT05893719: Prospective, Multicentre Study to Evaluate the Thrombectomy System for Stroke: iNedit, iNdeep and iNtercept
Official title: First Prospective, Single-arm, Multicentre Study to Evaluate the Safety and Efficacy of the Overall Thrombectomy System for Stroke: iNedit, iNdeep and iNtercept in Patients With Acute Ischemic Stroke.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Ischemic Stroke
Keywords: Stroke
Mechanical Neurothrombectomy
Ischemia
Lead sponsor: iVascular S.L.U.
Sponsor class: INDUSTRY
First posted: 2023-06-08
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Performance Success
timeFrame: In the course of endovascular procedure, evaluated immediately after it.
measure: MAE
timeFrame: 24 hours (-8/+12 hours)
measure: Mortality
timeFrame: 90 days
Secondary outcomes:
measure: Clinical progress
timeFrame: 90 days
measure: Proportion of patients with rapid neurological improvement
timeFrame: 24 hours after treatment
measure: Reduction of NIHSS scale
timeFrame: At 72 hours or at the time of discharge, whichever occurs first.
measure: Procedure duration
timeFrame: In the course of endovascular procedure, evaluated immediately after it.
measure: Number of passes with the device until recanalization.
timeFrame: In the course of endovascular procedure, evaluated immediately after it.
measure: Percentage of effective recanalization in a first pass.
timeFrame: In the course of endovascular procedure, evaluated immediately after it.
measure: Rate of cases that reached the occlusion and allowed the performance of the trombectomy.
timeFrame: In the course of endovascular procedure, evaluated immediately after it.
measure: Assessment of intracranial haemorrhage (ICH)
timeFrame: 24 (-8/+12) hours
measure: Neurological deterioration
timeFrame: 24 (-8/+12) hours.
measure: Embolization rate
timeFrame: In the course of endovascular procedure, evaluated immediately after it.
measure: Mortality rate
timeFrame: 3 days (+/-24) hours
measure: Procedure complication rate
timeFrame: In the course of endovascular procedure, evaluated immediately after it.
measure: Rate of infarction in a previously non-involved vascular territory
timeFrame: 24 hours.
Other outcomes:
Locations:
city: Kortrijk
country: Belgium
facility: Hospital AZ Groeninge
city: Ludwigsburg
country: Germany
facility: Hospital Klinikum Ludwigsburg
city: Munich
country: Germany
facility: Hospital LMU Klinikum
city: Nürnberg
country: Germany
facility: Hospital Klinikum Nürnberg
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Badajoz
country: Spain
facility: Hospital Universitario de Badajoz
city: Baracaldo
country: Spain
facility: Hospital de Cruces
city: Barcelona
country: Spain
facility: Hospital de la Vall d'Hebrón
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial de Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitario de Bellvitge
city: Barcelona
country: Spain
facility: Hospital GermansTrias i Pujol
city: Córdoba
country: Spain
facility: Hospital Reina Sofia de Córdoba
city: Las Palmas De Gran Canaria
country: Spain
facility: Hospital Insular de Gran Canaria
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Valencia
country: Spain
facility: Hospital Clínico de Valencia
city: Valencia
country: Spain
facility: Hospital La Fe
Study officials:
References:
citation: 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.
citation: 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.