Factors Affecting Clinical and Radiological Outcome in Endovascular Management of Acute Ischemic Stroke Due to Large Vessel Occlusion

NCT07740018 | Recruiting

• 1 other identifier: soh-med--26-7-4MD
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Acute ischemic stroke (AIS), particularly if it is caused by a large-vessel occlusion (LVO), is a severe and life-threatening disease. Endovascular therapy (EVT) has rendered safe and effective treatment of AIS due to LVO possible, and new thrombolytic agents and neuroprotectants could soon complement pharmacological AIS therapy. These treatments are highly time dependent. Hence, the overarching goal in the management of patients with AIS is to rapidly and safely transfer, diagnose, and treat patients with AIS (1). The only available 2 treatment options are intravenous alteplase and endovascular therapy (mechanical clot removal), both of which are highly time dependent. Thus, rapid patient transfer, diagnosis, and treatment are crucial, and time-consuming imaging methods and overly selective treatment selection criteria should be avoided (2). Imaging is crucial for AIS management, as it confirms the diagnosis and guides treatment, with intravenous tissue plasminogen activator (alteplase) and/or EVT, the 2 evidence-based treatment strategies for AIS. Every 30-min delay in recanalization decreases the chance of a good functional outcome by 8% to 14% (3). Clinical outcome after large-vessel occlusive strokes depends on admitting clinical condition, successful recanalization, and robust collateral circulation. However, predicting successful recanalization and quantifying collateral status in the acute setting remain elusive (4). Successful recanalization has many predictive factors. Strong evidence supports increasing clot length being associated with poor recanalization. Current imaging techniques completed in the acute setting suggest that clot length can be estimated with a clot burden score (5). Studies consistently show that independent predictors in clinical outcome remain the patient's admission clinical condition as evaluated by baseline NIH Stroke Scale (NIHSS) scores and ischemic lesion volume. Emphasis on lesion volume suggested that stroke mechanism, particularly lacunar strokes with their smaller ischemic volumes, could be an independent predictor for favorable clinical outcome. However, predicting clinical outcome with stroke mechanism, particularly in large vessel occlusions (LVO), remains elusive (6). As thrombus origin site (i.e., vein, artery, or heart) is thought to play a role in clot composition, cardioembolic and paradoxical strokes with their greater fibrin content and red cells were thought to be more susceptible to fibrinolysis than heterogeneous, chronic thrombotic arterial plaques formed in artery-to-artery strokes. However, studies continue to show that stroke mechanism does not influence recanalization or clinical outcome after intravenous rt-PA (IVtPA) (7). Radiological signs that are readily available on a patient's index CT scan have generated interest as predictors for patients undergoing EVT for LVO AIS. For example, poor baseline collateral flow status and Alberta Stroke Program Early CT Score (ASPECTS), assessed via CT angiography, are associated with a larger ischemic core and worse functional outcomes. Other radiological variables which have been investigated include clot characteristics including clot length, density, surface phenotype, truncal versus branch-type occlusions and the presence of a meniscus sign. Further radiological variables that have been studied pertain to vascular anatomy and include parameters that quantify vascular tortuosity such as the aortic arch type (8). Despite advances in the management of acute ischemic stroke due to large-vessel occlusion, significant variability still exists in both clinical and radiological outcomes among patients. Moreover, the relative contribution and interaction of different clinical and imaging predictors in determining treatment success and functional recovery remain not fully established. In addition, there is still no complete consensus regarding the most reliable predictors of recanalization and favorable outcomes in the acute setting, particularly in relation to thrombus characteristics, collateral status, and vascular anatomy (9). Therefore, this study aims to evaluate factors affecting clinical and radiological outcome in management of acute ischemic stroke due to large vessel occlusion.

Conditions

Endovascular Thrombectomy

Outcome Measures

Primary Outcomes (3)

• Early neurological improvement

  Neurological status will be evaluated using the National Institutes of Health Stroke Scale (NIHSS). Early neurological improvement is defined as a reduction of ≥4 points in NIHSS score or an NIHSS score of 0-1.

  24 hours after procedure

• modified ranken scale

  Functional outcome will be assessed using the modified Rankin Scale (mRS). A favorable outcome is defined as an mRS score of 0-2 at 90 days following endovascular treatment. The association between baseline clinical, radiological, procedural factors and functional outcome will be analyzed.

  90 days

• successful angiographic reperfusion

  Successful reperfusion will be assessed using the modified Thrombolysis in Cerebral Infarction (mTICI) grading system. Successful reperfusion is defined as mTICI grade 2b, 2c, or 3 at the end of the endovascular procedure.

  immediately after procedure

Study Arms (1)

endovascular thrombectomy

ACTIVE COMPARATOR

Procedure: endovascular thrombectomy

Interventions

endovascular thrombectomy PROCEDURE

Following radiological assessment and confirmation of eligibility, patients will be transferred directly to the angiography suite for endovascular treatment. Mechanical thrombectomy will be performed by direct aspiration, stent retriever thrombectomy, or a combined approach (Solumbra technique), according to the angiographic findings, vascular anatomy, and operator judgment. The procedural goal will be to achieve successful reperfusion while minimizing procedure-related complications. Following the procedure, patients will be admitted to the stroke unit or neurocritical care unit for close neurological and hemodynamic monitoring. Blood pressure, neurological status, and access-site complications will be monitored according to institutional stroke protocols . Antithrombotic therapy will be initiated or resumed after follow-up imaging confirms the absence of clinically significant intracranial hemorrhage, in accordance with current stroke management guidelines and the underlying stroke

endovascular thrombectomy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• General Criteria (Applicable to All Time Windows)
• Age ≥ 18 to 80 years old.
• Acute ischemic stroke due to large vessel occlusion (LVO) presenting within 24 hours from symptom onset or last known well. Occlusion involving one of the following vessels:
• internal carotid artery (ICA)
• M1 segment of the middle cerebral artery (MCA)
• A1 segment of the anterior cerebral artery (ACA)
• P1 segment of the posterior cerebral artery (PCA)
• Basilar artery (BA)
• V4 segment of the vertebral artery (VA)
• National Institutes of Health Stroke Scale (NIHSS) score ≥ 6. Patients Presenting Within 0-6 Hours from Symptom Onset or Last Known Well ,
• Alberta Stroke Program Early CT Score (ASPECTS) ≥ 6.
• Patients presenting 6-24 hours from the last known well, imaging eligibility based on :
• Estimated ischemic core volume \< 70 mL.
• Ratio of critically hypoperfused tissue to ischemic core (mismatch ratio) ≥ 1.8.
• Absolute volume of potentially salvageable tissue (Diffusion to flair mismatch volume) ≥ 15 mL.

You may not qualify if:

• Patients with stroke resulting from etiologies other than LVO.
• Individuals with a history of previous strokes.
• Hemorrhagic stroke
• Large established infarction (e.g., ASPECTS \< 6 for patients within the early time window or imaging findings not meeting eligibility criteria in the late window).
• Patients presenting 6-24 hours from the last known well who do not meet advanced imaging selection criteria (e.g., DEFUSE 3 or DAWN eligibility criteria).
• Pre-stroke disability with a modified Rankin Scale (mRS) score ≥2.
• Rapid improvement in neurological status to an NIHSS \< 6 or evidence of vessel recanalization prior to randomization.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Faculty of Medicine

Sohag, 82516, Egypt

RECRUITING

Related Publications (3)

• Ospel JM, Holodinsky JK, Goyal M. Management of Acute Ischemic Stroke Due to Large-Vessel Occlusion: JACC Focus Seminar. J Am Coll Cardiol. 2020 Apr 21;75(15):1832-1843. doi: 10.1016/j.jacc.2019.10.034.

  PMID: 32299595 RESULT

• Thomalla G, Boutitie F, Ma H, Koga M, Ringleb P, Schwamm LH, Wu O, Bendszus M, Bladin CF, Campbell BCV, Cheng B, Churilov L, Ebinger M, Endres M, Fiebach JB, Fukuda-Doi M, Inoue M, Kleinig TJ, Latour LL, Lemmens R, Levi CR, Leys D, Miwa K, Molina CA, Muir KW, Nighoghossian N, Parsons MW, Pedraza S, Schellinger PD, Schwab S, Simonsen CZ, Song SS, Thijs V, Toni D, Hsu CY, Wahlgren N, Yamamoto H, Yassi N, Yoshimura S, Warach S, Hacke W, Toyoda K, Donnan GA, Davis SM, Gerloff C; Evaluation of unknown Onset Stroke thrombolysis trials (EOS) investigators. Intravenous alteplase for stroke with unknown time of onset guided by advanced imaging: systematic review and meta-analysis of individual patient data. Lancet. 2020 Nov 14;396(10262):1574-1584. doi: 10.1016/S0140-6736(20)32163-2. Epub 2020 Nov 8.

  PMID: 33176180 RESULT

• Huo X, Sun D, Raynald, Jia B, Tong X, Wang A, Ma N, Gao F, Mo D, Ma G, Amin S, Ren Z, Miao Z; ANGEL-ACT study group. Endovascular Treatment in Acute Ischemic Stroke with Large Vessel Occlusion According to Different Stroke Subtypes: Data from ANGEL-ACT Registry. Neurol Ther. 2022 Mar;11(1):151-165. doi: 10.1007/s40120-021-00301-z. Epub 2021 Nov 20.

  PMID: 34800279 RESULT

Central Study Contacts

Mohammed ahmed kassem, assistant lecturer

CONTACT

00201098003153; mohamed011152@med.sohag.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: July 31, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: July 31, 2026

Record last verified: 2026-07

Locations

EG (1)