Acute Ischemic StrokeSEMTiCNCT05893719
Prospective, Multicentre Study to Evaluate the Thrombectomy System for Stroke: iNedit, iNdeep and iNtercept
An observational study of Acute Ischemic Stroke, run by iVascular S.L.U. at 18 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- iNedit, iNdeep, iNtercept
- Type of treatment
- Medical device
- How many people
- 175 participants
- Where
- 18 sitesin 3 countries
- Study dates
- 29 Jul 2022to 25 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Clinical:
- Age ≥18
- Informed consent signed by the patient or their representative; to use the patient's data
- Focal disabling neurologic deficit consistent with acute cerebral ischemia.
- Baseline NIHSS obtained before procedure of ≥6 points and ≤25 points.
- Pre-stroke mRS score ≤2.
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- 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:
- 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.
- For patients treated ≤8 hours:
- Score 6 to 10 on ASPECTS scale (Alberta Stroke Program Early CT Score).
- For patients treated between 8 and 24 hours:
- "Target Mismatch Profile" on CT perfusion or MRI (ischemic core volume is <70mL, mismatch ratio is >1,8 and mismatch volume is >15 mL).
- Ability to obtain selective angiography by catheterisation of the target artery.
Who cannot join
- Clinical:
- Patient has suffered a stroke in the past one year.
- Occlusion (TICI 0 or TICI 1) in vertebrobasilar territory.
- Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories.
- Known hemorrhagic diathesis, coagulaion factor deficiency or oral anti-vitamin K anticoagulant therapy with an INR >3.0.
- 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.
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- 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.
- Serious advanced or terminal illness with anticipated life expectancy of less than six months.
- History of life-threatening allergy (more than rash) to contrast medium.
- Known allergy to nickel, prior to treatment.
- Known renal insufficiency with creatinine ≥3 mg/dl or Glomerular Filtration Rate (GFR) <30 mL/min.
- Cerebral vasculitis.
- Known current cocaine use.
- Patient who is participating, at the time of inclusion, in a study with a device or drug that could affect this study.
- Patients who are unlikely to be available for 90-day follow-up (e.g. no fixed home address, visitors from overseas).
- Neuroimaging criteria:
- CT or MRI evidence of hemorrhage (the presence of microbleeds is allowed).
- Significant mass effect with midline shift.
- Evidence of complete occlusion, high-grade stenosis or arterial dissection in the extracranial or petrous segment of the internal carotid artery (TANDEM lesions).
- Patients with known or suspected underlying intracranial atherosclerotic lesions responsible for the target occlusion.
- Patients with occlusions in multiple vascular territories (e.g. bilateral anterior circulation or anterior/posterior circulation).
- Evidence of intracranial tumour with the exception of asymptomatic meningiomas with no mass effect.
- Presumed septic embolism with suspected aortic dissection or suspicion of bacterial endocarditis.
Trial locations and contacts
18 sites in 3 countries.
18 sites in 3 countries
Spain14 sites
Hospital General Universitario de Alicante
Alicante, 03010
Hospital Universitario de Badajoz
Badajoz, 06080
Hospital de Cruces
Barakaldo, 48903
Hospital de la Vall d'Hebrón
Barcelona, 08035
Hospital Clinic i Provincial de Barcelona
Barcelona, 08036
Hospital Universitario de Bellvitge
Barcelona, 08907
Hospital GermansTrias i Pujol
Barcelona, 08916
Hospital Reina Sofia de Córdoba
Córdoba, 14004
Hospital Insular de Gran Canaria
Las Palmas de Gran Canaria, 35016
Hospital General Universitario Gregorio Marañón
Madrid, 28007
Hospital Clínico San Carlos
Madrid, 28040
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011
Hospital Clínico de Valencia
Valencia, 46010
Hospital La Fe
Valencia, 46026
Germany3 sites
Hospital Klinikum Ludwigsburg
Ludwigsburg, 71640
Hospital LMU Klinikum
Munich, 80336
Hospital Klinikum Nürnberg
Nuremberg, 90471
About this study
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.
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.
Read the 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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- iNedit, iNdeep, iNtercept
- Keywords
- Stroke, Mechanical Neurothrombectomy, Ischemia
- Medical subject headings
- Ischemic Stroke, Stroke, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iNedit, iNdeep, iNterceptDevice
Patients to undergo mechanical thrombectomy with iNedit, iNdeep and iNtercept
| Study group | Role | What they receive |
|---|---|---|
| Experimental: iNedit, iNdeep, iNtercept | Study devices Receives: Device: iNedit, iNdeep, iNtercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: In the course of endovascular procedure, evaluated immediately after it.
MAE
All serious adverse events following the intervention or until an alternative stroke treatment is started, whichever occurs first.
Measured: 24 hours (-8/+12 hours)
Mortality
All-cause mortality
Measured: 90 days
Secondary outcomes (13)
Clinical progress
Good functional clinical progress (modified Rankin scale 0-2)
Measured: 90 days
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)
Measured: 24 hours after treatment
Reduction of NIHSS scale
Proportion of patients with a reduction of ≥8 points on the NIHSS scale or NIHSS 0-1
Measured: At 72 hours or at the time of discharge, whichever occurs first.
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.
Measured: In the course of endovascular procedure, evaluated immediately after it.
Number of passes with the device until recanalization.
Number of passes with the device until recanalization.
Measured: In the course of endovascular procedure, evaluated immediately after it.
Percentage of effective recanalization in a first pass.
Percentage of effective recanalization in a first pass.
Measured: In the course of endovascular procedure, evaluated immediately after it.
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.
Measured: In the course of endovascular procedure, evaluated immediately after it.
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).
Measured: 24 (-8/+12) hours
Neurological deterioration
Classification of neurological deterioration of ≥4 points on the NIHSS scale
Measured: 24 (-8/+12) hours.
Embolization rate
Embolization rate in a previously non-involved territory on cerebral angiography.
Measured: In the course of endovascular procedure, evaluated immediately after it.
Mortality rate
Mortality rate related to the procedure
Measured: 3 days (+/-24) hours
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.
Measured: In the course of endovascular procedure, evaluated immediately after it.
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).
Measured: 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start29 Jul 2022
- Primary completion17 Aug 2024
- Study completion25 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- iVascular S.L.U.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05893719
- Sponsor's protocol ID
- SEMTiC-01
- Acronym
- SEMTiC
- Status last verified
- May 2025
- First submitted
- 21 Jul 2022
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40134692Tomasello 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. 2026 Jun;32(3):411-418. doi: 10.1177/15910199231207407. Epub 2023 Oct 17.
PubMed 37847747
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05893719
- Acronym / sponsor ID
- SEMTiC / SEMTiC-01
- Conditions
- Acute Ischemic Stroke
- Keywords
- Stroke, Mechanical Neurothrombectomy, Ischemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- iVascular S.L.U.Industry (pharma, biotech, devices)
- Study start
- 29 Jul 2022 (actual)
- Primary completion
- 17 Aug 2024 (actual)
- Study completion
- 25 Feb 2025 (actual)
- First posted
- 8 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: iNedit, iNdeep, iNtercept | – | Device: iNedit, iNdeep, iNterceptStudy devices |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (14 listed)
- Age ≥18
- Informed consent signed by the patient or their representative; to use the patient's data
- Focal disabling neurologic deficit consistent with acute cerebral ischemia.
- Baseline NIHSS obtained before procedure of ≥6 points and ≤25 points.
- Pre-stroke mRS score ≤2.
Key exclusion criteria (23 listed)
- Patient has suffered a stroke in the past one year.
- Occlusion (TICI 0 or TICI 1) in vertebrobasilar territory.
- Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories.
- Known hemorrhagic diathesis, coagulaion factor deficiency or oral anti-vitamin K anticoagulant therapy with an INR >3.0.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iNedit, iNdeep, iNterceptPatients to undergo mechanical thrombectomy with iNedit, iNdeep and iNtercept | Device | Experimental: iNedit, iNdeep, iNtercept |
Primary outcome
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.
MAE
Time frame: 24 hours (-8/+12 hours)
All serious adverse events following the intervention or until an alternative stroke treatment is started, whichever occurs first.
Mortality
Time frame: 90 days
All-cause mortality
13 secondary outcomes
Clinical progress
Time frame: 90 days
Proportion of patients with rapid neurological improvement
Time frame: 24 hours after treatment
Reduction of NIHSS scale
Time frame: 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.
Number of passes with the device until recanalization.
Time frame: 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.
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.
Assessment of intracranial haemorrhage (ICH)
Time frame: 24 (-8/+12) hours
Neurological deterioration
Time frame: 24 (-8/+12) hours.
Embolization rate
Time frame: In the course of endovascular procedure, evaluated immediately after it.
Mortality rate
Time frame: 3 days (+/-24) hours
Procedure complication rate
Time frame: In the course of endovascular procedure, evaluated immediately after it.
Rate of infarction in a previously non-involved vascular territory
Time frame: 24 hours.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Results publication: PubMed 40134692San 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.
- Results publication: PubMed 37847747Tomasello 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. 2026 Jun;32(3):411-418. doi: 10.1177/15910199231207407. Epub 2023 Oct 17.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke, run by iVascular S.L.U. at 18 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Spain, Germany, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance Success (time frame: In the course of endovascular procedure, evaluated immediately after it.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05893719, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.