Acute Ischemic StrokePhase 4ATILANCT05225961
ATILA Project: Aspirin Versus Tirofiban in Endovascular Treatment for Patients With Acute Ischemic Stroke Due to Tandem Lesion
A Phase 4 study testing Tirofiban and Acetylsalicylic acid in people with Acute Ischemic Stroke, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 13 sites in Spain.
Trial summary
Patients with tandem lesions (TL) are defined as patients with an acute ischemic stroke (AIS) with occlusion of an intracranial vessel of the anterior circulation and an occlusion or severe stenosis (70-99%) of the origin of the ipsilateral internal carotid artery (ICA). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Tirofiban and Acetylsalicylic acid
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 13 sitesSpain
- Study dates
- 20 Mar 2026to 20 Mar 2026
- Phase
- Phase 4
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with acute ischemic stroke of the anterior territory secondary to a tandem lesion, with an indication for thrombectomy treatment according to the current recommendations of the Clinical Practice Guidelines, and the need for cervical stent placement.
- The intracranial occlusion locations that may be included are: carotid "T", M1 and M2 segments of the middle cerebral artery, segment A1 of the anterior cerebral artery; and in the case that the posterior cerebral artery has fetal origin and is the site of intracranial occlusion.
- ASPECTS (Alberta Stroke Program Early computerized Tomography Score) ≥6.
- Greater than or equal to 18 years of age.
- Signed informed consent.
Who cannot join
- Patients under 18 years of age.
- Patients with ASPECTS <6.
- Bilateral strokes or those produced by simultaneous occlusion of an artery in the anterior and posterior territory.
- Patients whose carotid stenosis is due to a re-stenosis or reocclusion of a pre-existing cervical stent.
- Candidate patients for carotid puncture.
- Previous treatment with double antiplatelet therapy for another cause prior to inclusion.
Show all 15Show fewer
- Severe comorbidity and / or reduced life expectancy.
- Modified Rankin scale (mRS)> 2.
- Severe allergy to contrast medium.
- Pregnant.
- Patients with intracranial occlusive arteriosclerotic disease or extra or intracranial dissection.
- Documented allergy to acetylsalicylic acid or Tirofiban.
- Personal history of platelet penia (Platelets <100,000)
- Concomitant anticoagulant treatment with presence of International Normalized Ratio (INR) > 1.7 in case of anti-vitamin K treatment or taking direct oral anticoagulant <48 hours ago)
- Medical history of the patient that carries a high risk of bleeding according to the investigator's criteria.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Spain13 sites
Complexo Hospitalario Universitario A Coruña
A Coruña, A Coruña
General Hospital Dr. Balmis (Alicante)
Alicante, Alicante
Complejo Hospitalario Torrecárdenas
Almería, Almería
Complejo Hospital Universitario de Badajoz
Badajoz, Badajoz
Germans Trias i Pujol Hospital
Badalona, Barcelona
Hospital Universitario de Cruces
Bilbao, Bilbao
Reina Sofía Hospital
Córdoba, Córdoba
Josep Trueta Hospital
Girona, Gerona
Ramón y Cajal Hospital
Madrid, Madrid
Hospital Clínico Universitario Virgen de la Arrixaca, Murcia
Murcia, Murcia
Virgen del Rocío Hospital
Seville, Seville
Virgen Macarena Hospital
Seville, Seville
Hospital Universitario y Politécnico de La Fe
Valencia, Valencia
About this study
Official title: Randomized Multi-center Clinical Trial to Assess Effectiveness and Safety of Tirofiban Versus Intravenous Aspirin in Patients With Acute Ischemic Stroke Secondary to Tandem Injury, Subject to Recanalization Therapy Through Endovascular Treatment
Patients with tandem lesions (TL) are defined as patients with an acute ischemic stroke (AIS) with occlusion of an intracranial vessel of the anterior circulation and an occlusion or severe stenosis (70-99%) of the origin of the ipsilateral internal carotid artery (ICA). The greatest current limitation in the management of this type of lesion is the use of antithrombotic medication (double antiaggregation) in the acute phase that is required in case of placing extracranial stent to stabilize the atheroma plaque. In relation to this antiplatelet regimen, the latest clinical practice guidelines warn about the risk of combining intravenous fibrinolysis with antiplatelet medication in the acute phase, since it seems to increase the risk of symptomatic intracranial hemorrhage (sICH). However, the non-stabilization of the carotid atheroma plaque is associated with higher rates of cervical reocclusion, poorer functional prognosis, and higher mortality.
Therefore, the use of a single antiplatelet agent could be a reasonable alternative. To establish the best protocol for mono-antiaggregant therapy in the acute phase of TL, the investigators propose to carry out a prospective multicenter randomized clinical trial.
- All patients with ischemic stroke secondary to TL in the anterior circulation candidates for mechanical thrombectomy in whom cervical endoprosthesis will be placed in the acute phase, will be included, randomized to two groups: 500 mg of intravenous (iv) Aspirin vs Low dose regimen of Tirofiban iv.
- Carotid reocclusion rates and sICH rates will be evaluated within the first 24 hours after mechanical thrombectomy . As a secondary objective, the functional prognosis at 3 months in both groups will be analyzed, as well as a panel of biomarkers predictors of reocclusion in both groups. Establishing an antiplatelet management protocol in the acute phase in these patients would be an innovative strategy not developed by any other group worldwide, and would place us at the forefront of research in the field. Likewise, developing a clinical-biological predictive model of carotid reocclusion will allow us to establish risk patients in which to plan alternative treatments. Reference hospitals in the treatment of ischemic stroke at the national level with sufficient experience in the management of this pathology will participate in the project.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Tirofiban, Acetylsalicylic acid
- Keywords
- Ischemic Stroke, Tandem Lesion, Tirofiban, Stent, Mechanical thrombectomy
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirofibanDrug
An intravenous bolus of 500 micrograms of Tirofiban will be intravenously administered in five minutes with an infusion pump (infusion rate: 120 milliliters / hour), which is equivalent to 500 micrograms of Tirofiban. After five minutes, a dose reduction will be programmed to 200 micrograms / hour (infusion rate: 4 milliliters / hour for 24 hours (maximum total infused dose of 96 milliliters). Tirofiban infusion started in the neuroradiology room should be maintained until a control brain computerized tomography (CT) scan is performed at 20 hours (+/-2 hours). Once the absence of parenchymal hematoma is demonstrated in control CT, loading doses of acetylsalicylic acid and clopidogrel will be intravenously administered in the Tirofiban group, and the perfusion must be maintained simultaneously of Tirofiban and oral double antiplatelet therapy for four hours, after which the administration of the experimental drug should be discontinued.
Acetylsalicylic acidDrug
A single dose 500 milligrams of Acetylsalicylic acid (ASPIRINA®, 500 mg) will be intravenously administered. The solution for injection should be prepared on the spot and used immediately after preparation. It is highly recommended to administer as soon as possible after femoral puncture and always before stent placement, allowing a 10-minute delay after placement of the cervical endoprosthesis. In case of exceeding this time, the patient will be withdrawn from the trial. It will not be necessary to maintain aspirin infusion. In the Acetylsalicylic acid group, a head computerized tomography scan will also be performed at 20 (+/- 2 hours) after the endovascular procedure. Once the absence of parenchymal hematoma is demonstrated, a load of clopidogrel and 100 mg of Acetylsalicylic acid will be administered. Oral antiplatelet medication can be administered orally if the patient has a good level of consciousness and is not associated with dysphagia; or by placing a nasogastric tube.
| Study group | Role | What they receive |
|---|---|---|
| Tirofiban | Experimental | An intravenous bolus of 500 micrograms of Tirofiban will be intravenously administered in five minutes with an infusion pump (infusion rate: 120 milliliters / hour), which is equivalent to 10 ml (500 micrograms) of Tirofiban. After five minutes, a dose reduction will be programmed to 200 micrograms / hour (infusion rate: 4 milliliters / hour for 24 hours (maximum total infused dose of 96 milliliters). Receives: Drug: Tirofiban |
| Acetylsalicylic acid | Active comparator | A single dose 500 milligrams of Acetylsalicylic acid (ASPIRINA®, 500 mg) will be intravenously administered. One vial of ASPIRINA ® in not more than 250 ml in 0.9% sodium chloride solution, 5% and 10% glucose solution, Ringer's solution or lactated Ringer's. The solution for injection should be prepared on the spot and used immediately after preparation. It is highly recommended to administer as soon as possible after femoral puncture and always before stent placement, allowing a 10-minute delay after placement of the cervical endoprosthesis. In case of exceeding this time, the patient will be withdrawn from the trial. Receives: Drug: Acetylsalicylic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carotid Reocclusion
Outcome measure assessment will be performed using ultrasound doppler, in which carotid reocclusion is define by:
- the presence at the level of the occlusion point, by a characteristic biphasic, brief and low speed pattern both in the Doppler spectrum and in color mode (color image with both orthodromic and antidromic flow, red-blue just proximal to the occlusion.
- An anechoic appearance with a false appearance of permeable light, detecting the absence of flow in color and Doppler modes.
Measured: Annually (single evaluation): within the first 24 hours (+/- 12hours)
Platelet aggregation phenomena
Outcome measure assessment will be performed using ultrasound doppler, in which carotid reocclusion is define by:
- the presence at the level of the occlusion point, by a characteristic biphasic, brief and low speed pattern both in the Doppler spectrum and in color mode (color image with both orthodromic and antidromic flow, red-blue just proximal to the occlusion.
- An anechoic appearance with a false appearance of permeable light, detecting the absence of flow in color and Doppler modes
Measured: Annually (single evaluation): within the first 24 hours (+/- 12hours)
Symptomatic intracranial hemorrhage (sICH)
The sICH is defined as a new intracranial hemorrhage in brain computerized tomography within hospitalization related to an National institute of Health Stroke Scale score increase >4 points compared with stroke admission.
Measured: Within first 24 hours after inclusion
Secondary outcomes (1)
Good functional prognosis
Defined as a score on the modified rankin scale (mRS) between 0-2 at 90 days.
Measured: At 90 days (+/- 7 days) after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start20 Mar 2026
- Primary completion20 Mar 2026
- Study completion20 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elena Zapata-Arrizada, PhD, Principal investigator, Virgen del Rocío Hospital, Seville, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05225961
- Sponsor's protocol ID
- ATILA-ictus-2021
- Acronym
- ATILA
- Status last verified
- Mar 2026
- First submitted
- 29 Nov 2021
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zapata-Arriaza E, Medina-Rodriguez M, Moniche Alvarez F, de Alboniga-Chindurza A, Aguilar-Perez M, Ainz-Gomez L, Baena-Palomino P, Zamora A, Pardo-Galiana B, Delgado-Acosta F, Valverde Moyano R, Jimenez-Gomez E, Bravo Rey I, Oteros Fernandez R, Escudero-Martinez I, Vielba-Gomez I, Morales Caba L, Diaz Perez J, Garcia Molina E, Mosteiro S, Castellanos Rodrigo MDM, Amaya Pascasio L, Hidalgo C, Freijo Guerrero MDM, Gonzalez Diaz E, Ramirez Moreno JM, Fernandez Prudencio L, Terceno Izaga M, Bashir Viturro S, Gamero-Garcia MA, Jimenez Jorge S, Rosso Fernandez C, Montaner J, Gonzalez Garcia A. Statistical analysis plan for the multicenter, open, randomized controlled clinical trial to assess the efficacy and safety of intravenous tirofiban vs aspirin in acute ischemic stroke due to tandem lesion, undergoing recanalization therapy by endovascular treatment (ATILA trial). Trials. 2024 Jan 9;25(1):35. doi: 10.1186/s13063-023-07817-9.
PubMed 38195586
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Multi-center Clinical Trial to Assess Effectiveness and Safety of Tirofiban Versus Intravenous Aspirin in Patients With Acute Ischemic Stroke Secondary to Tandem Injury, Subject to Recanalization Therapy Through Endovascular Treatment
- ClinicalTrials.gov ID
- NCT05225961
- Acronym / sponsor ID
- ATILA / ATILA-ictus-2021
- Conditions
- Acute Ischemic Stroke
- Keywords
- Ischemic Stroke, Tandem Lesion, Tirofiban, Stent, Mechanical thrombectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Study start
- 20 Mar 2026 (actual)
- Primary completion
- 20 Mar 2026 (actual)
- Study completion
- 20 Mar 2026 (actual)
- First posted
- 7 Feb 2022 (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.
Patients with tandem lesions (TL) are defined as patients with an acute ischemic stroke (AIS) with occlusion of an intracranial vessel of the anterior circulation and an occlusion or severe stenosis (70-99%) of the origin of the ipsilateral internal carotid artery (ICA). The greatest current limitation in the management of this type of lesion is the use of antithrombotic medication (double antiaggregation) in the acute phase that is required in case of placing extracranial stent to stabilize the atheroma plaque. In relation to this antiplatelet regimen, the latest clinical practice guidelines warn about the risk of combining intravenous fibrinolysis with antiplatelet medication in the acute phase, since it seems to increase the risk of symptomatic intracranial hemorrhage (sICH). However, the non-stabilization of the carotid atheroma plaque is associated with higher rates of cervical reocclusion, poorer functional prognosis, and higher mortality.
Therefore, the use of a single antiplatelet agent could be a reasonable alternative. To establish the best protocol for mono-antiaggregant therapy in the acute phase of TL, the investigators propose to carry out a prospective multicenter randomized clinical trial.
- All patients with ischemic stroke secondary to TL in the anterior circulation candidates for mechanical thrombectomy in whom cervical endoprosthesis will be placed in the acute phase, will be included, randomized to two groups: 500 mg of intravenous (iv) Aspirin vs Low dose regimen of Tirofiban iv.
- Carotid reocclusion rates and sICH rates will be evaluated within the first 24 hours after mechanical thrombectomy . As a secondary objective, the functional prognosis at 3 months in both groups will be analyzed, as well as a panel of biomarkers predictors of reocclusion in both groups. Establishing an antiplatelet management protocol in the acute phase in these patients would be an innovative strategy not developed by any other group worldwide, and would place us at the forefront of research in the field. Likewise, developing a clinical-biological predictive model of carotid reocclusion will allow us to establish risk patients in which to plan alternative treatments. Reference hospitals in the treatment of ischemic stroke at the national level with sufficient experience in the management of this pathology will participate in the project.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tirofiban | Experimental | Drug: TirofibanAn intravenous bolus of 500 micrograms of Tirofiban will be intravenously administered in five minutes with an infusion pump (infusion rate: 120 milliliters / hour), which is equivalent to 10 ml (500 micrograms) of Tirofiban. After five minutes, a dose reduction will be programmed to 200 micrograms / hour (infusion rate: 4 milliliters / hour for 24 hours (maximum total infused dose of 96 milliliters). |
| Acetylsalicylic acid | Active comparator | Drug: Acetylsalicylic acidA single dose 500 milligrams of Acetylsalicylic acid (ASPIRINA®, 500 mg) will be intravenously administered. One vial of ASPIRINA ® in not more than 250 ml in 0.9% sodium chloride solution, 5% and 10% glucose solution, Ringer's solution or lactated Ringer's. The solution for injection should be prepared on the spot and used immediately after preparation. It is highly recommended to administer as soon as possible after femoral puncture and always before stent placement, allowing a 10-minute delay after placement of the cervical endoprosthesis. In case of exceeding this time, the patient will be withdrawn from the trial. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with acute ischemic stroke of the anterior territory secondary to a tandem lesion, with an indication for thrombectomy treatment according to the current recommendations of the Clinical Practice Guidelines, and the need for cervical stent placement.
- The intracranial occlusion locations that may be included are: carotid "T", M1 and M2 segments of the middle cerebral artery, segment A1 of the anterior cerebral artery; and in the case that the posterior cerebral artery has fetal origin and is the site of intracranial occlusion.
- ASPECTS (Alberta Stroke Program Early computerized Tomography Score) ≥6.
- Greater than or equal to 18 years of age.
- Signed informed consent.
Key exclusion criteria (15 listed)
- Patients under 18 years of age.
- Patients with ASPECTS <6.
- Bilateral strokes or those produced by simultaneous occlusion of an artery in the anterior and posterior territory.
- Patients whose carotid stenosis is due to a re-stenosis or reocclusion of a pre-existing cervical stent.
- Candidate patients for carotid puncture.
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 |
|---|---|---|
| TirofibanAn intravenous bolus of 500 micrograms of Tirofiban will be intravenously administered in five minutes with an infusion pump (infusion rate: 120 milliliters / hour), which is equivalent to 500 micrograms of Tirofiban. After five minutes, a dose reduction will be programmed to 200 micrograms / hour (infusion rate: 4 milliliters / hour for 24 hours (maximum total infused dose of 96 milliliters). Tirofiban infusion started in the neuroradiology room should be maintained until a control brain computerized tomography (CT) scan is performed at 20 hours (+/-2 hours). Once the absence of parenchymal hematoma is demonstrated in control CT, loading doses of acetylsalicylic acid and clopidogrel will be intravenously administered in the Tirofiban group, and the perfusion must be maintained simultaneously of Tirofiban and oral double antiplatelet therapy for four hours, after which the administration of the experimental drug should be discontinued. | Drug | Tirofiban |
| Acetylsalicylic acidA single dose 500 milligrams of Acetylsalicylic acid (ASPIRINA®, 500 mg) will be intravenously administered. The solution for injection should be prepared on the spot and used immediately after preparation. It is highly recommended to administer as soon as possible after femoral puncture and always before stent placement, allowing a 10-minute delay after placement of the cervical endoprosthesis. In case of exceeding this time, the patient will be withdrawn from the trial. It will not be necessary to maintain aspirin infusion. In the Acetylsalicylic acid group, a head computerized tomography scan will also be performed at 20 (+/- 2 hours) after the endovascular procedure. Once the absence of parenchymal hematoma is demonstrated, a load of clopidogrel and 100 mg of Acetylsalicylic acid will be administered. Oral antiplatelet medication can be administered orally if the patient has a good level of consciousness and is not associated with dysphagia; or by placing a nasogastric tube. | Drug | Acetylsalicylic acid |
Primary outcome
Carotid Reocclusion
Time frame: Annually (single evaluation): within the first 24 hours (+/- 12hours)
Outcome measure assessment will be performed using ultrasound doppler, in which carotid reocclusion is define by: * the presence at the level of the occlusion point, by a characteristic biphasic, brief and low speed pattern both in the Doppler spectrum and in color mode (color image with both orthodromic and antidromic flow, red-blue just proximal to the occlusion. * An anechoic appearance with a false appearance of permeable light, detecting the absence of flow in color and Doppler modes.
Platelet aggregation phenomena
Time frame: Annually (single evaluation): within the first 24 hours (+/- 12hours)
Outcome measure assessment will be performed using ultrasound doppler, in which carotid reocclusion is define by: * the presence at the level of the occlusion point, by a characteristic biphasic, brief and low speed pattern both in the Doppler spectrum and in color mode (color image with both orthodromic and antidromic flow, red-blue just proximal to the occlusion. * An anechoic appearance with a false appearance of permeable light, detecting the absence of flow in color and Doppler modes
Symptomatic intracranial hemorrhage (sICH)
Time frame: Within first 24 hours after inclusion
The sICH is defined as a new intracranial hemorrhage in brain computerized tomography within hospitalization related to an National institute of Health Stroke Scale score increase >4 points compared with stroke admission.
1 secondary outcome
Good functional prognosis
Time frame: At 90 days (+/- 7 days) after inclusion
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 3 Apr 2026.
- Derived from this study: PubMed 38195586Zapata-Arriaza E, Medina-Rodriguez M, Moniche Alvarez F, de Alboniga-Chindurza A, Aguilar-Perez M, Ainz-Gomez L, Baena-Palomino P, Zamora A, Pardo-Galiana B, Delgado-Acosta F, Valverde Moyano R, Jimenez-Gomez E, Bravo Rey I, Oteros Fernandez R, Escudero-Martinez I, Vielba-Gomez I, Morales Caba L, Diaz Perez J, Garcia Molina E, Mosteiro S, Castellanos Rodrigo MDM, Amaya Pascasio L, Hidalgo C, Freijo Guerrero MDM, Gonzalez Diaz E, Ramirez Moreno JM, Fernandez Prudencio L, Terceno Izaga M, Bashir Viturro S, Gamero-Garcia MA, Jimenez Jorge S, Rosso Fernandez C, Montaner J, Gonzalez Garcia A. Statistical analysis plan for the multicenter, open, randomized controlled clinical trial to assess the efficacy and safety of intravenous tirofiban vs aspirin in acute ischemic stroke due to tandem lesion, undergoing recanalization therapy by endovascular treatment (ATILA trial). Trials. 2024 Jan 9;25(1):35. doi: 10.1186/s13063-023-07817-9.
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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.
Elena Zapata-Arrizada, PhD principal investigator
Virgen del Rocío Hospital, Seville, Spain
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tirofiban and Acetylsalicylic acid in people with Acute Ischemic Stroke, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 13 sites in Spain.
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 5 inclusion and 15 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 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Carotid Reocclusion (time frame: Annually (single evaluation): within the first 24 hours (+/- 12hours)). 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 NCT05225961, which also lists 1 linked publication.
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 3 Apr 2026.