Prospective, Multicentre Study to Evaluate the Thrombectomy System for Stroke: INEDIT, INDEEP and INTERCEPT

Acute Ischemic Stroke Clinical Trial

— SEMTiC  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05893719
• Other study ID #: SEMTiC-01
• Status: Recruiting
• Start date: July 1, 2022
• Est. completion date: July 2023

Study information

• Verified date: May 2023
• Source: iVascular S.L.U.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 225
• Est. completion date: July 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 8 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. Initially treated with a different thrombectomy device in the same procedure.

2. Patient has suffered a stroke in the past one year.

3. Occlusion (TICI 0 or TICI 1) in vertebrobasilar territory.

4. Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories.

5. Known hemorrhagic diathesis, coagulaion factor deficiency or oral anti-vitamin K anticoagulant therapy with an INR >3.0.

6. 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.

7. 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.

8. Serious advanced or terminal illness with anticipated life expectancy of less than six months.

9. History of life-threatening allergy (more than rash) to contrast medium.

10. Known allergy to nickel, prior to treatment.

11. Known renal insufficiency with creatinine =3 mg/dl or Glomerular Filtration Rate (GFR) <30 mL/min.

12. Cerebral vasculitis.

13. Known current cocaine use.

14. Patient who is participating, at the time of inclusion, in a study with a device or drug that could affect this study.

15. 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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemic Stroke
• Stroke

Intervention

Device:
• iNedit, iNdeep, iNtercept
Patients to undergo mechanical thrombectomy with iNedit, iNdeep and iNtercept

Locations

Country	Name	City	State
Belgium	Hospital AZ Groeninge	Kortrijk
France	Hospital Universitario CHU Bordeaux	Bordeaux
France	Hospital Bicetre	Paris
Germany	Hospital Klinikum Ludwigsburg	Ludwigsburg
Germany	Hospital LMU Klinikum	Munich
Germany	Hospital Klinikum Nürnberg	Nürnberg
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Hospital Universitario de Badajoz	Badajoz
Spain	Hospital de Cruces	Baracaldo
Spain	Hospital Clinic i Provincial de Barcelona	Barcelona
Spain	Hospital de la Vall d'Hebrón	Barcelona
Spain	Hospital GermansTrias i Pujol	Barcelona
Spain	Hospital Universitario de Bellvitge	Barcelona
Spain	Hospital Reina Sofia de Córdoba	Córdoba
Spain	Hospital Insular de Gran Canaria	Las Palmas De Gran Canaria
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital General Universitario Gregorio Marañón	Madrid
Spain	Hospital Universitario Central de Asturias	Oviedo	Asturias
Spain	Hospital Clínico de Valencia	Valencia
Spain	Hospital La Fe	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
iVascular S.L.U.

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	MAE	All serious adverse events following the intervention or until an alternative stroke treatment is started, whichever occurs first.	24 hours (-8/+12 h)
Primary	Mortality	All-cause mortality	90 days
Secondary	Clinical progress	Good functional clinical progress (modified Rankin scale 0-2)	90 days
Secondary	Proportion of patients with rapid neurological improvement	Proportion of patients with rapid neurological improvement (more than 4 points on the NIHSS scale, or NIHSS =4)	24 hours after treatment
Secondary	Reduction of NIHSS scale	Proportion of patients with a reduction of =8 points on the NIHSS scale or NIHSS 0-1	At 72 hours or at the time of discharge, whichever occurs first.
Secondary	Procedure duration	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.	In the course of endovascular procedure, evaluated immediately after it.
Secondary	Number of passes with the device until recanalization.	Number of passes with the device until recanalization.	In the course of endovascular procedure, evaluated immediately after it.
Secondary	Percentage of effective recanalization in a first pass.	Percentage of effective recanalization in a first pass.	In the course of endovascular procedure, evaluated immediately after it.
Secondary	Rate of cases that reached the occlusion and allowed the performance of the trombectomy.	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.	In the course of endovascular procedure, evaluated immediately after it.
Secondary	Assessment of intracranial haemorrhage (ICH)	Assessment of intracranial haemorrhage (ICH); any symptomatic or asymptomatic intracranial haemorrhage assessed by magnetic resonance imaging (MRI) /computed tomography (CT).	24 (-8/+12) hours
Secondary	Neurological deterioration	Classification of neurological deterioration of =4 points on the NIHSS scale	24 (-8/+12) hours.
Secondary	Embolization rate	Embolization rate in a previously non-involved territory on cerebral angiography.	In the course of endovascular procedure, evaluated immediately after it.
Secondary	Mortality rate	Mortality rate related to the procedure	3 days (+/-24) hours
Secondary	Procedure complication rate	Procedure complication rate: arterial perforation, arterial dissection and vasospasm in the target vessel and embolization in a previously non-involved vascular territory.	In the course of endovascular procedure, evaluated immediately after it.
Secondary	Rate of infarction in a previously non-involved vascular territory	Rate of infarction in a previously non-involved vascular territory, as evaluated by imaging (MRI/CT).	24 hours.