Acute Ischemic StrokeNCT06427187
Mechanical Thrombectomy of Acute Ischemic Stroke Anterior Circulation Distal Vessel Occlusion
A study testing an array of devices are used in thrombectomy. These include guide catheters, stent-retrievers, microcatheters, aspiration catheters, and aspiration pump systems in people with Acute Ischemic Stroke, run by Assiut University.
Trial summary
Ischemic stroke continues to be of the leading causes of disability and death. Distal vessel occlusion one of most presenting and disabling varieties of ischemic stroke. Distal vessel occlusion stroke is a type of ischemic stroke that affects the small arteries in the brain, usually beyond the M2 segment of the middle… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- an array of devices are used in thrombectomy. These include guide catheters, stent-retrievers, microcatheters, aspiration catheters, and aspiration pump systems
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 1 Jul 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a. Inclusion criteria:
- Diagnosis of an acute ischemic stroke due to an occlusion of the anterior cerebral artery (ACA) in the A1-A3 segment 2. Diagnosis of an acute ischemic stroke due to an occlusion of the middle cerebral artery in the distal M2 segment or the M3 segment.
Who cannot join
- Posterior circulation small vessel occlusion
- Tandem lesions with occlusion of the ipsilateral ICA were excluded.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Outcomes of Mechanical Thrombectomy of Acute Ischemic Stroke Anterior Circulation Distal Vessel Occlusion
Ischemic stroke continues to be of the leading causes of disability and death. Distal vessel occlusion one of most presenting and disabling varieties of ischemic stroke. Distal vessel occlusion stroke is a type of ischemic stroke that affects the small arteries in the brain, usually beyond the M2 segment of the middle cerebral artery. These strokes can cause various neurological symptoms depending on the location and size of the occluded vessel and the extent of the brain tissue damage
Read the detailed description
DMVOs are defined by the Distal Thrombectomy Summit Group consensus statement as thromboembolic occlusion of the anterior cerebral artery, M2-M4 middle cerebral artery (MCA), posterior cerebral artery (PCA), posterior inferior cerebellar artery, anterior inferior cerebellar artery or superior cerebellar artery. It is estimated that 25-40% of all AIS is due to DMVO.Though distal vessel occlusion associated with poor disabling comorbidities'.With different aetiology weather primary Embolic from (heart, carotid or aorta),thrombotic (atherosclerotic, hypertension or Diabetes ,smoking \&hyperlipidaemia) or Secondary distal vessel occlusion that occurs as a complication of a proximal large vessel occlusion, either spontaneously or after treatment with intravenous thrombolysis or endovascular thrombectomy. This can be due to thrombus fragmentation and migration or incomplete reperfusion of the affected vascular territory . Endovascular thrombectomy is well established as a highly effective treatment for acute ischemic stroke (AIS) due to proximal, large vessel occlusions (PLVOs). Recent advances in stent retriever and aspiration catheter technology are more promising results to reach more distal vessels, with a good outcome. However, MT in M2 emerging with different technique using stent Retriever or aspiration or both nowadays, evidence of other MT in distal vessel occlusion is poor.
- Conditions
- Acute Ischemic Stroke
- Being tested
- an array of devices are used in thrombectomy. These include guide catheters, stent-retrievers, microcatheters, aspiration catheters, and aspiration pump systems
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
an array of devices are used in thrombectomy. These include guide catheters, stent-retrievers, microcatheters, aspiration catheters, and aspiration pump systemsDevice
each patient with distal vessel occlusion subjected to mechanical thrombectomy using aspiration technique or stent retriever
| Study group | Role | What they receive |
|---|---|---|
| distal vessel occlusion Mechanical thromectomy | Experimental | Each presenting Patient with acute distal vessel occlusion of anterior circulation with (A1-A3)or (M2-M3) either mechanical thrombectomy (MT) with or without intra-venous thrombolysis (IVT) according to standard medical guidelines. MT was performed using approved aspiration catheters or stent-retrievers or both. Receives: Device: an array of devices are used in thrombectomy. These include guide catheters, stent-retrievers, microcatheters, aspiration catheters, and aspiration pump systems |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thrombolysis in Cerebral Infarction (TICI)
The original description was based on the angiographic appearances of the treated occluded vessel and the distal branches:
grade 0: no perfusion grade 1: penetration with minimal perfusion grade 2: partial perfusion grade 2A: only partial filling (less than two-thirds) of the entire vascular territory is visualized grade 2B: complete filling of all of the expected vascular territory is visualized but the filling is slower than normal grade 3: complete perfusion
Measured: 1 day , 10 day
modified Thrombolysis in Cerebral Infarction scale (mTICI)
grade 0: no perfusion grade 1: antegrade reperfusion past the initial occlusion, but limited distal branch filling with little or slow distal reperfusion grade 2 grade 2a: antegrade reperfusion of less than half of the occluded target artery previously ischemic territory (e.g. in one major division of the middle cerebral artery (MCA) and its territory) grade 2b: antegrade reperfusion of more than half of the previously occluded target artery ischemic territory (e.g. in two major divisions of the MCA and their territories) grade 2c: near complete perfusion except for slow flow or distal emboli in a few distal cortical vessels this was not part of the original mTICI score, but was added later and has since become widely accepted as being part of the scoring 4 grade 3: complete antegrade reperfusion of the previously occluded target artery ischemic territory, with absence of visualized occlusion in all distal branches
Measured: 1 day , 10 day
Secondary outcomes (2)
mRS
90 Days modified Rankin scale (mRS) score The Modified Rankin Scale (mRS) is used to measure the degree of disability in patients who have had a stroke, as follows 0: No symptoms at all
- No significant disability despite symptoms; able to carry out all usual duties and activities
- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
- Moderate disability; requiring some help, but able to walk without assistance
- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
- Severe disability; bedridden, incontinent and requiring constant nursing care and attention
- Dead
Measured: three months
Safety outcomes were defined as 90-day mortality and occurrence of symptomatic intracranial haemorrhage (sICH).
Safety outcomes were defined as 90-day mortality and occurrence of symptomatic intracranial haemorrhage (sICH).
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Model description
- Each presenting Patient subjected to: * careful history including Age, Sex, comorbid diseases (hypertension, Diabetes, dyslipidemia, cardiac disease...), time from onset to treatment * examination: Vital signs * NIHSS at admission * Lab investigation: basic lab, metabolic profile \& Lipid profile * The diagnosis was made using a standard CT stroke protocol including CT head Aspect score, arterial CT angiography, and perfusion CT. In some cases, primary stroke MRI was performed including fluid attenuated inversion recovery (FLAIR), diffusion weighted imaging (DWI): in order to evaluate location of occluded vessel, size of ischemic core \& penumbra). All patients received either mechanical thrombectomy (MT) with or without intra-venous thrombolysis (IVT) according to standard medical guidelines. MT was performed using approved aspiration catheters or stent-retrievers or both.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Zayed Saber, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06427187
- Sponsor's protocol ID
- Mechanical throbectomy
- Status last verified
- May 2024
- First submitted
- 18 May 2024
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kunz WG, Almekhlafi MA, Goyal M. Distal Vessel Occlusions: When to Consider Endovascular Thrombectomy. Stroke. 2018 Jul;49(7):1581-1583. doi: 10.1161/STROKEAHA.118.021887. Epub 2018 Jun 18. No abstract available.
PubMed 29915118Sepp D, Hernandez Petzsche MR, Zarth T, Wunderlich S, Ikenberg B, Maegerlein C, Zimmer C, Berndt MT, Boeckh-Behrens T, Kirschke JS. Mechanical thrombectomy of distal cerebral vessel occlusions of the anterior circulation. Sci Rep. 2023 Apr 7;13(1):5730. doi: 10.1038/s41598-023-32634-0.
PubMed 37029202Saver JL, Chapot R, Agid R, Hassan A, Jadhav AP, Liebeskind DS, Lobotesis K, Meila D, Meyer L, Raphaeli G, Gupta R; Distal Thrombectomy Summit Group*dagger. Thrombectomy for Distal, Medium Vessel Occlusions: A Consensus Statement on Present Knowledge and Promising Directions. Stroke. 2020 Sep;51(9):2872-2884. doi: 10.1161/STROKEAHA.120.028956. Epub 2020 Aug 6. No abstract available.
PubMed 32757757Kobeissi H, Bilgin C, Ghozy S, Kadirvel R, Kallmes DF, Brinjikji W. A review of acute ischemic stroke caused by distal, medium vessel occlusions. Interv Neuroradiol. 2025 Dec;31(6):846-851. doi: 10.1177/15910199231197616. Epub 2023 Aug 29.
PubMed 37644821Lima FO, Furie KL, Silva GS, Lev MH, Camargo EC, Singhal AB, Harris GJ, Halpern EF, Koroshetz WJ, Smith WS, Nogueira RG. Prognosis of untreated strokes due to anterior circulation proximal intracranial arterial occlusions detected by use of computed tomography angiography. JAMA Neurol. 2014 Feb;71(2):151-7. doi: 10.1001/jamaneurol.2013.5007.
PubMed 24323077Elhorany M, Rosso C, Shotar E, Baronnet-Chauvet F, Premat K, Lenck S, Crozier S, Corcy C, Bottin L, Mansour OY, Talbi A, El-Din EAT, Fadel WA, Sourour NA, Alamowitch S, Samson Y, Clarencon F. Safety and effectiveness of mechanical thrombectomy for primary isolated distal vessel occlusions: A monocentric retrospective comparative study. J Neuroradiol. 2022 Jun;49(4):311-316. doi: 10.1016/j.neurad.2022.03.008. Epub 2022 Apr 6.
PubMed 35397949Guenego A, Mine B, Bonnet T, Elens S, Vazquez Suarez J, Jodaitis L, Ligot N, Naeije G, Lubicz B. Thrombectomy for distal medium vessel occlusion with a new generation of Stentretriever (Tigertriever 13). Interv Neuroradiol. 2022 Aug;28(4):444-454. doi: 10.1177/15910199211039926. Epub 2021 Sep 13.
PubMed 34516332Alawieh AM, Chalhoub RM, Al Kasab S, Jabbour P, Psychogios MN, Starke RM, Arthur AS, Fargen KM, De Leacy R, Kan P, Dumont TM, Rai A, Crosa RJ, Maier I, Goyal N, Wolfe SQ, Cawley CM, Mocco J, Tjoumakaris SI, Howard BM, Dimisko L, Saad H, Ogilvy CS, Crowley RW, Mascitelli JR, Fragata I, Levitt MR, Kim JT, Park MS, Gory B, Polifka AJ, Matouk C, Grossberg JA, Spiotta AM; STAR Collaborators. Multicenter investigation of technical and clinical outcomes after thrombectomy for distal vessel occlusion by frontline technique. J Neurointerv Surg. 2023 Sep;15(e1):e93-e101. doi: 10.1136/jnis-2022-019023. Epub 2022 Aug 2.
PubMed 35918129Sweid A, Head J, Tjoumakaris S, Xu V, Shivashankar K, Alexander TD, Dougherty JA, Gooch MR, Herial N, Hasan D, DePrince M, Rosenwasser RH, Jabbour P. Mechanical Thrombectomy in Distal Vessels: Revascularization Rates, Complications, and Functional Outcome. World Neurosurg. 2019 Oct;130:e1098-e1104. doi: 10.1016/j.wneu.2019.07.098. Epub 2019 Jul 16.
PubMed 31323418Atchaneeyasakul K, Malik AM, Yavagal DR, Haussen DC, Jadhav AP, Bouslama M, Kenmuir CL, Desai S, Grossberg JA, Chaturvedi S, Jovin TG, Nogueira RG. Thrombectomy Outcomes in Acute Ischemic Stroke due to Middle Cerebral Artery M2 Occlusion with Stent Retriever versus Aspiration: A Multicenter Experience. Interv Neurol. 2020 Jan;8(2-6):180-186. doi: 10.1159/000500198. Epub 2019 Jun 18.
PubMed 32508900Sacks D, Baxter B, Campbell BCV, Carpenter JS, Cognard C, Dippel D, Eesa M, Fischer U, Hausegger K, Hirsch JA, Hussain MS, Jansen O, Jayaraman MV, Khalessi AA, Kluck BW, Lavine S, Meyers PM, Ramee S, Rufenacht DA, Schirmer CM, Vorwerk D. Multisociety Consensus Quality Improvement Revised Consensus Statement for Endovascular Therapy of Acute Ischemic Stroke: From the American Association of Neurological Surgeons (AANS), American Society of Neuroradiology (ASNR), Cardiovascular and Interventional Radiology Society of Europe (CIRSE), Canadian Interventional Radiology Association (CIRA), Congress of Neurological Surgeons (CNS), European Society of Minimally Invasive Neurological Therapy (ESMINT), European Society of Neuroradiology (ESNR), European Stroke Organization (ESO), Society for Cardiovascular Angiography and Interventions (SCAI), Society of Interventional Radiology (SIR), Society of NeuroInterventional Surgery (SNIS), and World Stroke Organization (WSO). J Vasc Interv Radiol. 2018 Apr;29(4):441-453. doi: 10.1016/j.jvir.2017.11.026. Epub 2018 Mar 1. No abstract available.
PubMed 29478797Zaidat OO, Yoo AJ, Khatri P, Tomsick TA, von Kummer R, Saver JL, Marks MP, Prabhakaran S, Kallmes DF, Fitzsimmons BF, Mocco J, Wardlaw JM, Barnwell SL, Jovin TG, Linfante I, Siddiqui AH, Alexander MJ, Hirsch JA, Wintermark M, Albers G, Woo HH, Heck DV, Lev M, Aviv R, Hacke W, Warach S, Broderick J, Derdeyn CP, Furlan A, Nogueira RG, Yavagal DR, Goyal M, Demchuk AM, Bendszus M, Liebeskind DS; Cerebral Angiographic Revascularization Grading (CARG) Collaborators; STIR Revascularization working group; STIR Thrombolysis in Cerebral Infarction (TICI) Task Force. Recommendations on angiographic revascularization grading standards for acute ischemic stroke: a consensus statement. Stroke. 2013 Sep;44(9):2650-63. doi: 10.1161/STROKEAHA.113.001972. Epub 2013 Aug 6. No abstract available.
PubMed 23920012
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Mechanical Thrombectomy of Acute Ischemic Stroke Anterior Circulation Distal Vessel Occlusion
- ClinicalTrials.gov ID
- NCT06427187
- Acronym / sponsor ID
- Mechanical throbectomy
- Conditions
- Acute Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 23 May 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.
Ischemic stroke continues to be of the leading causes of disability and death. Distal vessel occlusion one of most presenting and disabling varieties of ischemic stroke. Distal vessel occlusion stroke is a type of ischemic stroke that affects the small arteries in the brain, usually beyond the M2 segment of the middle cerebral artery. These strokes can cause various neurological symptoms depending on the location and size of the occluded vessel and the extent of the brain tissue damage
Detailed description
DMVOs are defined by the Distal Thrombectomy Summit Group consensus statement as thromboembolic occlusion of the anterior cerebral artery, M2-M4 middle cerebral artery (MCA), posterior cerebral artery (PCA), posterior inferior cerebellar artery, anterior inferior cerebellar artery or superior cerebellar artery. It is estimated that 25-40% of all AIS is due to DMVO.Though distal vessel occlusion associated with poor disabling comorbidities'.With different aetiology weather primary Embolic from (heart, carotid or aorta),thrombotic (atherosclerotic, hypertension or Diabetes ,smoking \&hyperlipidaemia) or Secondary distal vessel occlusion that occurs as a complication of a proximal large vessel occlusion, either spontaneously or after treatment with intravenous thrombolysis or endovascular thrombectomy. This can be due to thrombus fragmentation and migration or incomplete reperfusion of the affected vascular territory . Endovascular thrombectomy is well established as a highly effective treatment for acute ischemic stroke (AIS) due to proximal, large vessel occlusions (PLVOs). Recent advances in stent retriever and aspiration catheter technology are more promising results to reach more distal vessels, with a good outcome. However, MT in M2 emerging with different technique using stent Retriever or aspiration or both nowadays, evidence of other MT in distal vessel occlusion is poor.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each presenting Patient subjected to: * careful history including Age, Sex, comorbid diseases (hypertension, Diabetes, dyslipidemia, cardiac disease...), time from onset to treatment * examination: Vital signs * NIHSS at admission * Lab investigation: basic lab, metabolic profile \& Lipid profile * The diagnosis was made using a standard CT stroke protocol including CT head Aspect score, arterial CT angiography, and perfusion CT. In some cases, primary stroke MRI was performed including fluid attenuated inversion recovery (FLAIR), diffusion weighted imaging (DWI): in order to evaluate location of occluded vessel, size of ischemic core \& penumbra). All patients received either mechanical thrombectomy (MT) with or without intra-venous thrombolysis (IVT) according to standard medical guidelines. MT was performed using approved aspiration catheters or stent-retrievers or both.
| Arm | Type | Receives |
|---|---|---|
| distal vessel occlusion Mechanical thromectomy | Experimental | Device: an array of devices are used in thrombectomy. These include guide catheters, stent-retrievers, microcatheters, aspiration catheters, and aspiration pump systemsEach presenting Patient with acute distal vessel occlusion of anterior circulation with (A1-A3)or (M2-M3) either mechanical thrombectomy (MT) with or without intra-venous thrombolysis (IVT) according to standard medical guidelines. MT was performed using approved aspiration catheters or stent-retrievers or both. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- a. Inclusion criteria:
Key exclusion criteria (2 listed)
- Posterior circulation small vessel occlusion
- Tandem lesions with occlusion of the ipsilateral ICA were excluded.
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 |
|---|---|---|
| an array of devices are used in thrombectomy. These include guide catheters, stent-retrievers, microcatheters, aspiration catheters, and aspiration pump systemseach patient with distal vessel occlusion subjected to mechanical thrombectomy using aspiration technique or stent retriever | Device | distal vessel occlusion Mechanical thromectomy |
Primary outcome
Thrombolysis in Cerebral Infarction (TICI)
Time frame: 1 day , 10 day
The original description was based on the angiographic appearances of the treated occluded vessel and the distal branches: grade 0: no perfusion grade 1: penetration with minimal perfusion grade 2: partial perfusion grade 2A: only partial filling (less than two-thirds) of the entire vascular territory is visualized grade 2B: complete filling of all of the expected vascular territory is visualized but the filling is slower than normal grade 3: complete perfusion
modified Thrombolysis in Cerebral Infarction scale (mTICI)
Time frame: 1 day , 10 day
grade 0: no perfusion grade 1: antegrade reperfusion past the initial occlusion, but limited distal branch filling with little or slow distal reperfusion grade 2 grade 2a: antegrade reperfusion of less than half of the occluded target artery previously ischemic territory (e.g. in one major division of the middle cerebral artery (MCA) and its territory) grade 2b: antegrade reperfusion of more than half of the previously occluded target artery ischemic territory (e.g. in two major divisions of the MCA and their territories) grade 2c: near complete perfusion except for slow flow or distal emboli in a few distal cortical vessels this was not part of the original mTICI score, but was added later and has since become widely accepted as being part of the scoring 4 grade 3: complete antegrade reperfusion of the previously occluded target artery ischemic territory, with absence of visualized occlusion in all distal branches
2 secondary outcomes
mRS
Time frame: three months
Safety outcomes were defined as 90-day mortality and occurrence of symptomatic intracranial haemorrhage (sICH).
Time frame: three months
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 23 May 2024.
- Background: PubMed 29915118Kunz WG, Almekhlafi MA, Goyal M. Distal Vessel Occlusions: When to Consider Endovascular Thrombectomy. Stroke. 2018 Jul;49(7):1581-1583. doi: 10.1161/STROKEAHA.118.021887. Epub 2018 Jun 18. No abstract available.
- Background: PubMed 37029202Sepp D, Hernandez Petzsche MR, Zarth T, Wunderlich S, Ikenberg B, Maegerlein C, Zimmer C, Berndt MT, Boeckh-Behrens T, Kirschke JS. Mechanical thrombectomy of distal cerebral vessel occlusions of the anterior circulation. Sci Rep. 2023 Apr 7;13(1):5730. doi: 10.1038/s41598-023-32634-0.
- Background: PubMed 32757757Saver JL, Chapot R, Agid R, Hassan A, Jadhav AP, Liebeskind DS, Lobotesis K, Meila D, Meyer L, Raphaeli G, Gupta R; Distal Thrombectomy Summit Group*dagger. Thrombectomy for Distal, Medium Vessel Occlusions: A Consensus Statement on Present Knowledge and Promising Directions. Stroke. 2020 Sep;51(9):2872-2884. doi: 10.1161/STROKEAHA.120.028956. Epub 2020 Aug 6. No abstract available.
- Background: PubMed 37644821Kobeissi H, Bilgin C, Ghozy S, Kadirvel R, Kallmes DF, Brinjikji W. A review of acute ischemic stroke caused by distal, medium vessel occlusions. Interv Neuroradiol. 2025 Dec;31(6):846-851. doi: 10.1177/15910199231197616. Epub 2023 Aug 29.
- Background: PubMed 24323077Lima FO, Furie KL, Silva GS, Lev MH, Camargo EC, Singhal AB, Harris GJ, Halpern EF, Koroshetz WJ, Smith WS, Nogueira RG. Prognosis of untreated strokes due to anterior circulation proximal intracranial arterial occlusions detected by use of computed tomography angiography. JAMA Neurol. 2014 Feb;71(2):151-7. doi: 10.1001/jamaneurol.2013.5007.
- Background: PubMed 35397949Elhorany M, Rosso C, Shotar E, Baronnet-Chauvet F, Premat K, Lenck S, Crozier S, Corcy C, Bottin L, Mansour OY, Talbi A, El-Din EAT, Fadel WA, Sourour NA, Alamowitch S, Samson Y, Clarencon F. Safety and effectiveness of mechanical thrombectomy for primary isolated distal vessel occlusions: A monocentric retrospective comparative study. J Neuroradiol. 2022 Jun;49(4):311-316. doi: 10.1016/j.neurad.2022.03.008. Epub 2022 Apr 6.
- Background: PubMed 34516332Guenego A, Mine B, Bonnet T, Elens S, Vazquez Suarez J, Jodaitis L, Ligot N, Naeije G, Lubicz B. Thrombectomy for distal medium vessel occlusion with a new generation of Stentretriever (Tigertriever 13). Interv Neuroradiol. 2022 Aug;28(4):444-454. doi: 10.1177/15910199211039926. Epub 2021 Sep 13.
- Background: PubMed 35918129Alawieh AM, Chalhoub RM, Al Kasab S, Jabbour P, Psychogios MN, Starke RM, Arthur AS, Fargen KM, De Leacy R, Kan P, Dumont TM, Rai A, Crosa RJ, Maier I, Goyal N, Wolfe SQ, Cawley CM, Mocco J, Tjoumakaris SI, Howard BM, Dimisko L, Saad H, Ogilvy CS, Crowley RW, Mascitelli JR, Fragata I, Levitt MR, Kim JT, Park MS, Gory B, Polifka AJ, Matouk C, Grossberg JA, Spiotta AM; STAR Collaborators. Multicenter investigation of technical and clinical outcomes after thrombectomy for distal vessel occlusion by frontline technique. J Neurointerv Surg. 2023 Sep;15(e1):e93-e101. doi: 10.1136/jnis-2022-019023. Epub 2022 Aug 2.
- Background: PubMed 31323418Sweid A, Head J, Tjoumakaris S, Xu V, Shivashankar K, Alexander TD, Dougherty JA, Gooch MR, Herial N, Hasan D, DePrince M, Rosenwasser RH, Jabbour P. Mechanical Thrombectomy in Distal Vessels: Revascularization Rates, Complications, and Functional Outcome. World Neurosurg. 2019 Oct;130:e1098-e1104. doi: 10.1016/j.wneu.2019.07.098. Epub 2019 Jul 16.
- Background: PubMed 32508900Atchaneeyasakul K, Malik AM, Yavagal DR, Haussen DC, Jadhav AP, Bouslama M, Kenmuir CL, Desai S, Grossberg JA, Chaturvedi S, Jovin TG, Nogueira RG. Thrombectomy Outcomes in Acute Ischemic Stroke due to Middle Cerebral Artery M2 Occlusion with Stent Retriever versus Aspiration: A Multicenter Experience. Interv Neurol. 2020 Jan;8(2-6):180-186. doi: 10.1159/000500198. Epub 2019 Jun 18.
- Background: PubMed 29478797Sacks D, Baxter B, Campbell BCV, Carpenter JS, Cognard C, Dippel D, Eesa M, Fischer U, Hausegger K, Hirsch JA, Hussain MS, Jansen O, Jayaraman MV, Khalessi AA, Kluck BW, Lavine S, Meyers PM, Ramee S, Rufenacht DA, Schirmer CM, Vorwerk D. Multisociety Consensus Quality Improvement Revised Consensus Statement for Endovascular Therapy of Acute Ischemic Stroke: From the American Association of Neurological Surgeons (AANS), American Society of Neuroradiology (ASNR), Cardiovascular and Interventional Radiology Society of Europe (CIRSE), Canadian Interventional Radiology Association (CIRA), Congress of Neurological Surgeons (CNS), European Society of Minimally Invasive Neurological Therapy (ESMINT), European Society of Neuroradiology (ESNR), European Stroke Organization (ESO), Society for Cardiovascular Angiography and Interventions (SCAI), Society of Interventional Radiology (SIR), Society of NeuroInterventional Surgery (SNIS), and World Stroke Organization (WSO). J Vasc Interv Radiol. 2018 Apr;29(4):441-453. doi: 10.1016/j.jvir.2017.11.026. Epub 2018 Mar 1. No abstract available.
- Background: PubMed 23920012Zaidat OO, Yoo AJ, Khatri P, Tomsick TA, von Kummer R, Saver JL, Marks MP, Prabhakaran S, Kallmes DF, Fitzsimmons BF, Mocco J, Wardlaw JM, Barnwell SL, Jovin TG, Linfante I, Siddiqui AH, Alexander MJ, Hirsch JA, Wintermark M, Albers G, Woo HH, Heck DV, Lev M, Aviv R, Hacke W, Warach S, Broderick J, Derdeyn CP, Furlan A, Nogueira RG, Yavagal DR, Goyal M, Demchuk AM, Bendszus M, Liebeskind DS; Cerebral Angiographic Revascularization Grading (CARG) Collaborators; STIR Revascularization working group; STIR Thrombolysis in Cerebral Infarction (TICI) Task Force. Recommendations on angiographic revascularization grading standards for acute ischemic stroke: a consensus statement. Stroke. 2013 Sep;44(9):2650-63. doi: 10.1161/STROKEAHA.113.001972. Epub 2013 Aug 6. No abstract available.
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Active, not recruiting
Efficacy and Safety of Endovascular Recanalization for Acute Basilar Artery Occlusion With Extended Time Window (ANGEL-BAO)
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Questions about this trial
What is this clinical trial studying?
A study testing an array of devices are used in thrombectomy. These include guide catheters, stent-retrievers, microcatheters, aspiration catheters, and aspiration pump systems in people with Acute Ischemic Stroke, run by Assiut University.
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 2 inclusion and 2 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: opening soon, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Mohamed zayed, Master degree (+20109809943, mzayeds1206@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thrombolysis in Cerebral Infarction (TICI) (time frame: 1 day , 10 day). 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 NCT06427187, which also lists 12 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 23 May 2024.