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

iVascular

Status: Completed

Conditions: Acute Ischemic Stroke

Treatments: Device: iNedit, iNdeep, iNtercept

Study type: Observational

Funder types: Industry

Identifiers

NCT05893719

SEMTiC-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 175 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

175 participants in 1 patient group

Experimental: iNedit, iNdeep, iNtercept

Description:

Study devices

Treatment:

Device: iNedit, iNdeep, iNtercept