Acute Ischemic StrokeNCT06733246
Safety and Efficacy Evaluation of the Ceretrieve Device in the Treatment of AIS Patients
A study testing Aspiration 0 in people with Acute Ischemic Stroke, run by Ceretrieve Ltd. at 1 site in Germany.
Trial summary
The main objective of this clinical trial is to evaluate of the safety \& efficacy of the Ceretrieve device within 24 hours post thrombectomy procedure. This means to assess that the use with the Ceretrieve neuro-thrombectomy device that is designed to treat acute ischemic stroke patients raises no safety concerns and… 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?
- Aspiration 0
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteGermany
- Study dates
- 12 Nov 2024to 30 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Age ≥18 years of age
- Clinical signs consistent with acute ischemic stroke
- Subject is able to be treated within 24 hours of stroke symptom onset.
- Pre-stroke modified Rankin Score of 0 or 1
- NIHSS > 6 at the time of screening
- If intravenous thrombolysis (IVT) is indicated, initiation of IVT should be administered as soon as possible and no later than 4.5 hours of onset of stroke symptoms (onset time is defined as the last time when the patient was witnessed to be at baseline neurologic status), with investigator verification that the subject has received/is receiving the correct IVT dose for the estimated weight.
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- Intracranial occlusion defined as Modified Thrombolysis in Cerebral Infarction (mTICI) 0-1 flow confirmed by angiography that is accessible to the mechanical thrombectomy device in the following locations:
- 1. Intracranial internal carotid artery 2. M1 and/or M2 segment of the MCA 3. Vertebral artery 4. Basilar artery Note: M1 segment of the MCA is defined as the arterial trunk from its origin at the ICA to the first bifurcation or trifurcation into major branches neglecting the small temporo-polar branch.
- 8. A valid completed informed consent in accordance with the local ethics committee regulations.
Who cannot join
- Female who is pregnant or lactating or has a positive pregnancy test at time of admission.
- Rapid neurological improvement prior to study enrolment suggesting resolution of signs/symptoms of stroke
- Known serious sensitivity to radiographic contrast agents
- Known sensitivity to nickel, titanium metals, or their alloys
- Subjects already enrolled in other investigational studies that would interfere with study endpoints
- Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency. (A subject without history or suspicion of coagulopathy does not require INR or prothrombin time lab results to be available prior to enrolment.)
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- Life expectancy of less than 90 days
- Clinical presentation suggests a subarachnoid hemorrhage, even if the initial CT or MRI scan is normal.
- Suspicion of aortic dissection
- Subject with a comorbid disease or condition that would confound the neurological and functional evaluations or compromise survival or ability to complete follow-up assessments.
- Known to currently use or abuses alcohol (defined as regular or daily consumption of more than four alcoholic drinks per day).
- Known arterial condition (e.g., proximal vessel stenosis or pre-existing stent) that would prevent the device from reaching the target vessel and/or preclude safe recovery of the device
- Subject who requires balloon angioplasty or stenting of the carotid artery at the time of the index procedure
- Angiographic evidence of carotid dissection
- Imaging exclusion criteria:
- CT or MRI evidence of hemorrhage on presentation
- CT or MRI evidence of mass effect or intra-cranial tumor (except small meningioma)
- CT or MRI evidence of cerebral vasculitis
- CT or MRI-DWI showing ASPECTS 0-5 (or pc-ASPECTS 0-6 in the posterior circulation). Alternatively, if automated core volume assessment software is used, MRI-DWI or CTP core > 70cc.
- CT/MRI shows evidence of carotid dissection or complete cervical carotid occlusion requiring a stent
- Any imaging evidence that suggests, in the opinion of the investigator, that the subject is not appropriate for mechanical thrombectomy intervention while utilizing an aspiration approach (e.g. inability to navigate to the target lesion, moderate/large infarct with poor collateral circulation, etc.).
- Occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation) as confirmed by angiography, or clinical evidence of bilateral strokes or strokes in multiple territories.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Heidelberg University Hospital
Heidelberg, 69120
Sabine Johnson, Ms., +49 6221 56-37300, Sabine.Johnson@med.uni-heidelberg.de
Lena Eschelbach, Ms., +49 6221 56-37300, lena.eschelbach@med.uni-heidelberg.de
About this study
Official title: Evaluation of the Safey & Performance of the Ceretrieve Device Designed for Thrombus Removal in Intracranial Arteries Using an Aspiration Technique in Patients Suffering an Acute Ischemic Stroke (AIS)
The main objective of this clinical trial is to evaluate of the safety \& efficacy of the Ceretrieve device within 24 hours post thrombectomy procedure. This means to assess that the use with the Ceretrieve neuro-thrombectomy device that is designed to treat acute ischemic stroke patients raises no safety concerns and that it is found to be effective when it is used according to its intended purpose, which is revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (involving the internal carotid artery, middle cerebral artery- M1 and M2 segments, basilar, and vertebral arteries).
The study researchers will compare the efficacy and safety results of this study to data derived from the literature of FDA approved neuro-thrombectomy devices. The study hypothesis is that The Ceretrieve device would achieve successful reperfusion performance shall be similar to the safety \& performance derived from the literature.
Read more
The primary outcomes that will be measures are:
Performance:
Successful reperfusion, defined as core laboratory-adjudicated modified Thrombolysis in Cerebral Ischemia (mTICI) score 2b-3 within three passes of the Ceretrieve system without any rescue.
Safety:
Symptomatic intra-cranial hemorrhage within 24 (18-36) hours of the study procedure.
Patients who will participate in this study will be followed for a time period of 3 months. After discharge from the medical center, they will be asked to arrive to a one visit at the clinic for safety data collection and evaluation.
Read the detailed description
This study is designed as a prospective, multi-center, open-label, single-arm study.
Patient will be required to undergo screening evaluation to confirm he/she meet the eligibility study criteria and are suitable to be a study participant.
The study patient population is comprised of adult subjects 18 years old and above, suffering from acute ischemic stroke, with a new moderate-to-severe neurologic deficits, angiographically confirmed occlusion in the intracranial internal carotid, middle cerebral (M1 or M2 segment), basilar, or vertebral artery, and can undergo endovascular therapy (at least one Ceretrieve deployment in the target artery), within 24 hours of symptoms on set.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Aspiration 0
- Keywords
- Thrombectomy, Aspiration, Neuro-thrombectomy catheter, stroke
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspiration 0Device
Ceretrieve is a neuro-thrombectomy aspiration catheter deigned for clot removal in AIS patients.
| Study group | Role | What they receive |
|---|---|---|
| Ceretrieve treatment arm - patient will be treated with the Ceretrieve device - aspiration approach | Experimental | This is the only study arm. All patients found to be eligible will be treated with the Ceretrieve device. Receives: Device: Aspiration 0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Successful Reperfusion (mTICI 2b-3) Within Three Passes Without Rescue Therapy
Successful reperfusion defined as core laboratory-adjudicated modified Thrombolysis in Cerebral Ischemia (mTICI) score of 2b-3 achieved within three passes of the Ceretrieve system without use of rescue therapy.
Measured: intra-procedural
Number of Participants With Symptomatic Intracranial Hemorrhage Within 24 (18-36) Hours Post-Procedure
Symptomatic intracranial hemorrhage assessed within 24 (18-36) hours following the procedure.
Measured: 24 (18-36) hours post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start12 Nov 2024
- Primary completion30 May 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ceretrieve Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06733246
- Sponsor's protocol ID
- RA 304
- Status last verified
- Mar 2026
- First submitted
- 10 Dec 2024
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data in the study will undergo pseudo-anonymization process and there will be no identifiable details in the data collected on all study patients. In this study, all endpoints are aimed at assessing/analyzing events' rates to be compared against the applicable historical data, and not the review of individual cases data.
Publications
Turk AS 3rd, Siddiqui A, Fifi JT, De Leacy RA, Fiorella DJ, Gu E, Levy EI, Snyder KV, Hanel RA, Aghaebrahim A, Woodward BK, Hixson HR, Chaudry MI, Spiotta AM, Rai AT, Frei D, Almandoz JED, Kelly M, Arthur A, Baxter B, English J, Linfante I, Fargen KM, Mocco J. Aspiration thrombectomy versus stent retriever thrombectomy as first-line approach for large vessel occlusion (COMPASS): a multicentre, randomised, open label, blinded outcome, non-inferiority trial. Lancet. 2019 Mar 9;393(10175):998-1008. doi: 10.1016/S0140-6736(19)30297-1.
PubMed 30860055Guo X, Xiong Y, Huang X, Pan Z, Kang X, Chen C, Zhou J, Wang C, Lin S, Hu W, Wang L, Zheng F. Aspiration versus stent retriever for posterior circulation stroke: A meta-analysis. CNS Neurosci Ther. 2023 Feb;29(2):525-537. doi: 10.1111/cns.14045. Epub 2022 Dec 13.
PubMed 36513959Jolugbo P, Ariens RAS. Thrombus Composition and Efficacy of Thrombolysis and Thrombectomy in Acute Ischemic Stroke. Stroke. 2021 Mar;52(3):1131-1142. doi: 10.1161/STROKEAHA.120.032810. Epub 2021 Feb 10.
PubMed 33563020Pilgram-Pastor SM, Piechowiak EI, Dobrocky T, Kaesmacher J, Den Hollander J, Gralla J, Mordasini P. Stroke thrombectomy complication management. J Neurointerv Surg. 2021 Oct;13(10):912-917. doi: 10.1136/neurintsurg-2021-017349. Epub 2021 Jun 22.
PubMed 34158401Baek JH, Kim BM, Kang DH, Heo JH, Nam HS, Kim YD, Hwang YH, Kim YW, Kim YS, Kim DJ, Kwak HS, Roh HG, Lee YJ, Kim SH, Baik SK, Jeon P, Yoo J, Suh SH, Kim B, Kim JW, Suh S, Jeon HJ. Balloon Guide Catheter Is Beneficial in Endovascular Treatment Regardless of Mechanical Recanalization Modality. Stroke. 2019 Jun;50(6):1490-1496. doi: 10.1161/STROKEAHA.118.024723. Epub 2019 May 2.
PubMed 31043149Kim YW, Hwang YH, Kim YS, Kang DH. Frontline contact aspiration thrombectomy using SOFIA catheter for acute ischemic stroke: period-to-period comparison with Penumbra catheter. Acta Neurochir (Wien). 2019 Jun;161(6):1197-1204. doi: 10.1007/s00701-019-03914-4. Epub 2019 Apr 29.
PubMed 31037498Fanous AA, Siddiqui AH. Mechanical thrombectomy: Stent retrievers vs. aspiration catheters. Cor Vasa. 2016;58(2):e193-e203. doi:10.1016/j.crvasa.2016.01.004
Munich SA, Vakharia K, Levy EI. Overview of Mechanical Thrombectomy Techniques. Neurosurgery. 2019 Jul 1;85(suppl_1):S60-S67. doi: 10.1093/neuros/nyz071.
PubMed 31197338Huang JC, Bhaskar SMM. Clot Morphology in Acute Ischemic Stroke Decision Making. Int J Mol Sci. 2022 Oct 15;23(20):12373. doi: 10.3390/ijms232012373.
PubMed 36293230Zaidat OO, Castonguay AC, Linfante I, Gupta R, Martin CO, Holloway WE, Mueller-Kronast N, English JD, Dabus G, Malisch TW, Marden FA, Bozorgchami H, Xavier A, Rai AT, Froehler MT, Badruddin A, Nguyen TN, Taqi MA, Abraham MG, Yoo AJ, Janardhan V, Shaltoni H, Novakovic R, Abou-Chebl A, Chen PR, Britz GW, Sun CJ, Bansal V, Kaushal R, Nanda A, Nogueira RG. First Pass Effect: A New Measure for Stroke Thrombectomy Devices. Stroke. 2018 Mar;49(3):660-666. doi: 10.1161/STROKEAHA.117.020315. Epub 2018 Feb 19.
PubMed 29459390Patil S, Darcourt J, Messina P, Bozsak F, Cognard C, Doyle K. Characterising acute ischaemic stroke thrombi: insights from histology, imaging and emerging impedance-based technologies. Stroke Vasc Neurol. 2022 Aug;7(4):353-363. doi: 10.1136/svn-2021-001038. Epub 2022 Mar 3.
PubMed 35241632Haupt M, Gerner ST, Bahr M, Doeppner TR. Neuroprotective Strategies for Ischemic Stroke-Future Perspectives. Int J Mol Sci. 2023 Feb 22;24(5):4334. doi: 10.3390/ijms24054334.
PubMed 36901765Primiani CT, Vicente AC, Brannick MT, Turk AS, Mocco J, Levy EI, Siddiqui AH, Mokin M. Direct Aspiration versus Stent Retriever Thrombectomy for Acute Stroke: A Systematic Review and Meta-Analysis in 9127 Patients. J Stroke Cerebrovasc Dis. 2019 May;28(5):1329-1337. doi: 10.1016/j.jstrokecerebrovasdis.2019.01.034. Epub 2019 Feb 14.
PubMed 30772159Wahlgren N, Ahmed N, Davalos A, Ford GA, Grond M, Hacke W, Hennerici MG, Kaste M, Kuelkens S, Larrue V, Lees KR, Roine RO, Soinne L, Toni D, Vanhooren G; SITS-MOST investigators. Thrombolysis with alteplase for acute ischaemic stroke in the Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST): an observational study. Lancet. 2007 Jan 27;369(9558):275-82. doi: 10.1016/S0140-6736(07)60149-4.
PubMed 17258667
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safey & Performance of the Ceretrieve Device Designed for Thrombus Removal in Intracranial Arteries Using an Aspiration Technique in Patients Suffering an Acute Ischemic Stroke (AIS)
- ClinicalTrials.gov ID
- NCT06733246
- Acronym / sponsor ID
- RA 304
- Conditions
- Acute Ischemic Stroke
- Keywords
- Thrombectomy, Aspiration, Neuro-thrombectomy catheter, stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Ceretrieve Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 13 Dec 2024 (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.
The main objective of this clinical trial is to evaluate of the safety \& efficacy of the Ceretrieve device within 24 hours post thrombectomy procedure. This means to assess that the use with the Ceretrieve neuro-thrombectomy device that is designed to treat acute ischemic stroke patients raises no safety concerns and that it is found to be effective when it is used according to its intended purpose, which is revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (involving the internal carotid artery, middle cerebral artery- M1 and M2 segments, basilar, and vertebral arteries).
The study researchers will compare the efficacy and safety results of this study to data derived from the literature of FDA approved neuro-thrombectomy devices. The study hypothesis is that The Ceretrieve device would achieve successful reperfusion performance shall be similar to the safety \& performance derived from the literature.
The primary outcomes that will be measures are:
Performance:
Successful reperfusion, defined as core laboratory-adjudicated modified Thrombolysis in Cerebral Ischemia (mTICI) score 2b-3 within three passes of the Ceretrieve system without any rescue.
Safety:
Symptomatic intra-cranial hemorrhage within 24 (18-36) hours of the study procedure.
Patients who will participate in this study will be followed for a time period of 3 months. After discharge from the medical center, they will be asked to arrive to a one visit at the clinic for safety data collection and evaluation.
Detailed description
This study is designed as a prospective, multi-center, open-label, single-arm study.
Patient will be required to undergo screening evaluation to confirm he/she meet the eligibility study criteria and are suitable to be a study participant.
The study patient population is comprised of adult subjects 18 years old and above, suffering from acute ischemic stroke, with a new moderate-to-severe neurologic deficits, angiographically confirmed occlusion in the intracranial internal carotid, middle cerebral (M1 or M2 segment), basilar, or vertebral artery, and can undergo endovascular therapy (at least one Ceretrieve deployment in the target artery), within 24 hours of symptoms on set.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ceretrieve treatment arm - patient will be treated with the Ceretrieve device - aspiration approach | Experimental | Device: Aspiration 0This is the only study arm. All patients found to be eligible will be treated with the Ceretrieve device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥18 years of age
- Clinical signs consistent with acute ischemic stroke
- Subject is able to be treated within 24 hours of stroke symptom onset.
- Pre-stroke modified Rankin Score of 0 or 1
- NIHSS > 6 at the time of screening
Key exclusion criteria (22 listed)
- Female who is pregnant or lactating or has a positive pregnancy test at time of admission.
- Rapid neurological improvement prior to study enrolment suggesting resolution of signs/symptoms of stroke
- Known serious sensitivity to radiographic contrast agents
- Known sensitivity to nickel, titanium metals, or their alloys
- Subjects already enrolled in other investigational studies that would interfere with study endpoints
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 |
|---|---|---|
| Aspiration 0Ceretrieve is a neuro-thrombectomy aspiration catheter deigned for clot removal in AIS patients. | Device | Ceretrieve treatment arm - patient will be treated with the Ceretrieve device - aspiration approach |
Primary outcome
Number of Participants With Successful Reperfusion (mTICI 2b-3) Within Three Passes Without Rescue Therapy
Time frame: intra-procedural
Successful reperfusion defined as core laboratory-adjudicated modified Thrombolysis in Cerebral Ischemia (mTICI) score of 2b-3 achieved within three passes of the Ceretrieve system without use of rescue therapy.
Number of Participants With Symptomatic Intracranial Hemorrhage Within 24 (18-36) Hours Post-Procedure
Time frame: 24 (18-36) hours post procedure
Symptomatic intracranial hemorrhage assessed within 24 (18-36) hours following the procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Background: PubMed 30860055Turk AS 3rd, Siddiqui A, Fifi JT, De Leacy RA, Fiorella DJ, Gu E, Levy EI, Snyder KV, Hanel RA, Aghaebrahim A, Woodward BK, Hixson HR, Chaudry MI, Spiotta AM, Rai AT, Frei D, Almandoz JED, Kelly M, Arthur A, Baxter B, English J, Linfante I, Fargen KM, Mocco J. Aspiration thrombectomy versus stent retriever thrombectomy as first-line approach for large vessel occlusion (COMPASS): a multicentre, randomised, open label, blinded outcome, non-inferiority trial. Lancet. 2019 Mar 9;393(10175):998-1008. doi: 10.1016/S0140-6736(19)30297-1.
- Background: PubMed 36513959Guo X, Xiong Y, Huang X, Pan Z, Kang X, Chen C, Zhou J, Wang C, Lin S, Hu W, Wang L, Zheng F. Aspiration versus stent retriever for posterior circulation stroke: A meta-analysis. CNS Neurosci Ther. 2023 Feb;29(2):525-537. doi: 10.1111/cns.14045. Epub 2022 Dec 13.
- Background: PubMed 33563020Jolugbo P, Ariens RAS. Thrombus Composition and Efficacy of Thrombolysis and Thrombectomy in Acute Ischemic Stroke. Stroke. 2021 Mar;52(3):1131-1142. doi: 10.1161/STROKEAHA.120.032810. Epub 2021 Feb 10.
- Background: PubMed 34158401Pilgram-Pastor SM, Piechowiak EI, Dobrocky T, Kaesmacher J, Den Hollander J, Gralla J, Mordasini P. Stroke thrombectomy complication management. J Neurointerv Surg. 2021 Oct;13(10):912-917. doi: 10.1136/neurintsurg-2021-017349. Epub 2021 Jun 22.
- Background: PubMed 31043149Baek JH, Kim BM, Kang DH, Heo JH, Nam HS, Kim YD, Hwang YH, Kim YW, Kim YS, Kim DJ, Kwak HS, Roh HG, Lee YJ, Kim SH, Baik SK, Jeon P, Yoo J, Suh SH, Kim B, Kim JW, Suh S, Jeon HJ. Balloon Guide Catheter Is Beneficial in Endovascular Treatment Regardless of Mechanical Recanalization Modality. Stroke. 2019 Jun;50(6):1490-1496. doi: 10.1161/STROKEAHA.118.024723. Epub 2019 May 2.
- Background: PubMed 31037498Kim YW, Hwang YH, Kim YS, Kang DH. Frontline contact aspiration thrombectomy using SOFIA catheter for acute ischemic stroke: period-to-period comparison with Penumbra catheter. Acta Neurochir (Wien). 2019 Jun;161(6):1197-1204. doi: 10.1007/s00701-019-03914-4. Epub 2019 Apr 29.
- BackgroundFanous AA, Siddiqui AH. Mechanical thrombectomy: Stent retrievers vs. aspiration catheters. Cor Vasa. 2016;58(2):e193-e203. doi:10.1016/j.crvasa.2016.01.004
- Background: PubMed 31197338Munich SA, Vakharia K, Levy EI. Overview of Mechanical Thrombectomy Techniques. Neurosurgery. 2019 Jul 1;85(suppl_1):S60-S67. doi: 10.1093/neuros/nyz071.
- Background: PubMed 36293230Huang JC, Bhaskar SMM. Clot Morphology in Acute Ischemic Stroke Decision Making. Int J Mol Sci. 2022 Oct 15;23(20):12373. doi: 10.3390/ijms232012373.
- Background: PubMed 29459390Zaidat OO, Castonguay AC, Linfante I, Gupta R, Martin CO, Holloway WE, Mueller-Kronast N, English JD, Dabus G, Malisch TW, Marden FA, Bozorgchami H, Xavier A, Rai AT, Froehler MT, Badruddin A, Nguyen TN, Taqi MA, Abraham MG, Yoo AJ, Janardhan V, Shaltoni H, Novakovic R, Abou-Chebl A, Chen PR, Britz GW, Sun CJ, Bansal V, Kaushal R, Nanda A, Nogueira RG. First Pass Effect: A New Measure for Stroke Thrombectomy Devices. Stroke. 2018 Mar;49(3):660-666. doi: 10.1161/STROKEAHA.117.020315. Epub 2018 Feb 19.
- Background: PubMed 35241632Patil S, Darcourt J, Messina P, Bozsak F, Cognard C, Doyle K. Characterising acute ischaemic stroke thrombi: insights from histology, imaging and emerging impedance-based technologies. Stroke Vasc Neurol. 2022 Aug;7(4):353-363. doi: 10.1136/svn-2021-001038. Epub 2022 Mar 3.
- Background: PubMed 36901765Haupt M, Gerner ST, Bahr M, Doeppner TR. Neuroprotective Strategies for Ischemic Stroke-Future Perspectives. Int J Mol Sci. 2023 Feb 22;24(5):4334. doi: 10.3390/ijms24054334.
- Individual participant dataSharing planned: No. All data in the study will undergo pseudo-anonymization process and there will be no identifiable details in the data collected on all study patients. In this study, all endpoints are aimed at assessing/analyzing events' rates to be compared against the applicable historical data, and not the review of individual cases data.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aspiration 0 in people with Acute Ischemic Stroke, run by Ceretrieve Ltd. at 1 site in Germany.
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 9 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hilla Hilla Ben-Ezra, Ms. (+972-52-6511131, hilla@ceretrieve.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Successful Reperfusion (mTICI 2b-3) Within Three Passes Without Rescue Therapy (time frame: intra-procedural). The study lists 2 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 NCT06733246, which also lists 14 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 25 Mar 2026.