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

May 29, 2023 updated by: iVascular S.L.U.

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.

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.

Study Overview

Status

Recruiting

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

225

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Kortrijk, Belgium
        • Not yet recruiting
        • Hospital AZ Groeninge
        • Contact:
        • Principal Investigator:
          • Olivier François
      • Bordeaux, France
        • Not yet recruiting
        • Hospital Universitario CHU Bordeaux
        • Contact:
        • Principal Investigator:
          • Xavier Barreau
      • Paris, France
        • Not yet recruiting
        • Hospital BICETRE
        • Contact:
        • Principal Investigator:
          • Laurent Spelle
      • Ludwigsburg, Germany, 71640
        • Not yet recruiting
        • Hospital Klinikum Ludwigsburg
        • Contact:
        • Principal Investigator:
          • Stephan Meckel
      • Munich, Germany, 80336
        • Not yet recruiting
        • Hospital LMU Klinikum
        • Contact:
        • Principal Investigator:
          • Thomas Liebig
      • Nürnberg, Germany, 90471
        • Not yet recruiting
        • Hospital Klinikum Nürnberg
        • Contact:
        • Principal Investigator:
          • Markus Holtmannspöetter
      • Alicante, Spain, 03010
        • Recruiting
        • Hospital General Universitario de Alicante
        • Contact:
        • Principal Investigator:
          • Carlos Domínguez
      • Badajoz, Spain, 06080
        • Recruiting
        • Hospital Universitario de Badajoz
        • Contact:
        • Principal Investigator:
          • Luis Fernández-Prudencio
      • Baracaldo, Spain, 48903
        • Recruiting
        • Hospital De Cruces
        • Contact:
        • Principal Investigator:
          • Eva González
      • Barcelona, Spain, 08907
        • Recruiting
        • Hospital Universitario de Bellvitge
        • Contact:
        • Principal Investigator:
          • Oscar Chirife
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic i Provincial de Barcelona
        • Contact:
        • Principal Investigator:
          • Antonio López
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital de la Vall d'Hebron
        • Contact:
        • Principal Investigator:
          • Alejandro Tomasello
      • Barcelona, Spain, 08916
        • Recruiting
        • Hospital GermansTrias i Pujol
        • Contact:
        • Principal Investigator:
          • Carlos Castaño
      • Córdoba, Spain, 14004
        • Recruiting
        • Hospital Reina Sofía de Córdoba
        • Contact:
        • Principal Investigator:
          • Fernando Delgado
      • Las Palmas De Gran Canaria, Spain, 35016
        • Recruiting
        • Hospital Insular de Gran Canaria
        • Contact:
        • Principal Investigator:
          • Yeray Aguilar
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Clinico San Carlos
        • Contact:
        • Principal Investigator:
          • Manuel Moreu
      • Madrid, Spain, 28007
        • Recruiting
        • Hospital General Universitario Gregorio Marañon
        • Contact:
        • Principal Investigator:
          • Enrique Castro
      • Valencia, Spain, 46010
        • Recruiting
        • Hospital Clinico de Valencia
        • Contact:
        • Principal Investigator:
          • Joaquin Gil
      • Valencia, Spain, 46026
        • Recruiting
        • Hospital la Fe
        • Contact:
        • Principal Investigator:
          • Fernando Aparici
    • Asturias
      • Oviedo, Asturias, Spain, 33011
        • Recruiting
        • Hospital Universitario Central de Asturias
        • Contact:
        • Principal Investigator:
          • Pedro Vega

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Experimental: iNedit, iNdeep, iNtercept
Study devices
Patients to undergo mechanical thrombectomy with iNedit, iNdeep and iNtercept

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical progress
Time Frame: 90 days
Good functional clinical progress (modified Rankin scale 0-2)
90 days
Proportion of patients with rapid neurological improvement
Time Frame: 24 hours after treatment
Proportion of patients with rapid neurological improvement (more than 4 points on the NIHSS scale, or NIHSS ≤4)
24 hours after treatment
Reduction of NIHSS scale
Time Frame: 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
At 72 hours or at the time of discharge, whichever occurs first.
Procedure duration
Time Frame: 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.
In the course of endovascular procedure, evaluated immediately after it.
Number of passes with the device until recanalization.
Time Frame: 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.
Percentage of effective recanalization in a first pass.
Time Frame: In the course of endovascular procedure, evaluated immediately after it.
Percentage of effective recanalization in a first pass.
In the course of endovascular procedure, evaluated immediately after it.
Rate of cases that reached the occlusion and allowed the performance of the trombectomy.
Time Frame: 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.
In the course of endovascular procedure, evaluated immediately after it.
Assessment of intracranial haemorrhage (ICH)
Time Frame: 24 (-8/+12) hours
Assessment of intracranial haemorrhage (ICH); any symptomatic or asymptomatic intracranial haemorrhage assessed by magnetic resonance imaging (MRI) /computed tomography (CT).
24 (-8/+12) hours
Neurological deterioration
Time Frame: 24 (-8/+12) hours.
Classification of neurological deterioration of ≥4 points on the NIHSS scale
24 (-8/+12) hours.
Embolization rate
Time Frame: In the course of endovascular procedure, evaluated immediately after it.
Embolization rate in a previously non-involved territory on cerebral angiography.
In the course of endovascular procedure, evaluated immediately after it.
Mortality rate
Time Frame: 3 days (+/-24) hours
Mortality rate related to the procedure
3 days (+/-24) hours
Procedure complication rate
Time Frame: 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.
In the course of endovascular procedure, evaluated immediately after it.
Rate of infarction in a previously non-involved vascular territory
Time Frame: 24 hours.
Rate of infarction in a previously non-involved vascular territory, as evaluated by imaging (MRI/CT).
24 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Estimated)

July 1, 2023

Study Completion (Estimated)

July 1, 2023

Study Registration Dates

First Submitted

July 21, 2022

First Submitted That Met QC Criteria

May 29, 2023

First Posted (Actual)

June 8, 2023

Study Record Updates

Last Update Posted (Actual)

June 8, 2023

Last Update Submitted That Met QC Criteria

May 29, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Ischemic Stroke

Clinical Trials on iNedit, iNdeep, iNtercept

3
Subscribe