- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06953427
The Impact of Age on Short-term Post-thrombectomy Outcomes in Patients Aged 70 or Beyond With Acute Ischemic Stroke
Study Overview
Status
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Taichung, Taiwan, 433004
- Department of Interventional Neuro-Radiology, Kuang Tien General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥70 years
- Acute Ischemic Stroke due to large-vessel occlusion (LVO) confirmed by CT angiography or MR angiography
- underwent EVT within the standard treatment window
- available 3-month modified Rankin Scale (mRS) scores.
Exclusion Criteria:
- Premorbid mRS score >2
- Poor imaging quality precluding assessment
- Lack of follow-up data.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Patients with acute cerebral stroke who underwent endovascular thrombectomy
Only patients who aged 70 or above will be enrolled.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Post-endovascular thrombectomy modified Thrombolysis in Cerebral Infarction (mTICI) reperfusion grade
Time Frame: Immediate post-thrombectomy
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Modified Treatment In Cerebral Ischemia (TICI) scale: Score Definition 0: No reperfusion; 1: Flow beyond occlusion without distal branch reperfusion; 2a: Reperfusion of less than half of the downstream target arterial territory; 2b: Reperfusion of more than half, yet incomplete, in the downstream target arterial territory; 3: Complete reperfusion of the downstream target arterial territory, including distal branches with slow flow. This is an immediate post-procedure assessment relating to capillary-level reperfusion as measured on catheter angiography. |
Immediate post-thrombectomy
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Three-months post-EVT modified Rankin scale (mRS)
Time Frame: 3-months post-EVT
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Modified Rankin Scale Score Description 0: No symptoms at all;
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3-months post-EVT
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Spontaneous intracerebral hemorrhage
Time Frame: Day 2 to Day 90 post-EVT
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A CT scan will be performed on day 2 to detect any spontaneous intracerebral hemorrhage.
In patients who are fine on day 2, will perform CT scan to check bleeding when symptoms arise.
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Day 2 to Day 90 post-EVT
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Pao-Sheng Yen, MD, Kuang Tien General Hospital
Publications and helpful links
General Publications
- 1. Roaldsen MB, Jusufovic M, Berge E, Lindekleiv H. Endovascular thrombectomy and intra-arterial interventions for acute ischaemic stroke. Cochrane Database Syst Rev. 2021 Jun 14;6(6):Cd007574. 2. Costalat V, Jovin TG, Albucher JF, et al. Trial of Thrombectomy for Stroke with a Large Infarct of Unrestricted Size. N Engl J Med. 2024 May 9;390(18):1677-89. 3. Zerna C, Rogers E, Rabi DM, et al. Comparative Effectiveness of Endovascular Treatment for Acute Ischemic Stroke: A Population-Based Analysis. J Am Heart Assoc. 2020 Apr 7;9(7):e014541. 4. Adcock AK, Schwamm LH, Smith EE, et al. Trends in Use, Outcomes, and Disparities in Endovascular Thrombectomy in US Patients With Stroke Aged 80 Years and Older Compared With Younger Patients. JAMA Netw Open. 2022 Jun 1;5(6):e2215869. 5. Enriquez BAB, Halling HK, Lund CG, et al. Exploring the Impact of Age and Pre-Stroke Modified Rankin Scale in Elderly Thrombectomy: A 15-Year Single-Center Experience. Cerebrovasc Dis Extra. 2024;14(1):125-33. 6. Groot AE, Treurniet KM, Jansen IGH, et al. Endovascular treatment in older adults with acute ischemic stroke in the MR CLEAN Registry. Neurology. 2020 Jul 14;95(2):e131-e9. 7. Zhai G, Song J, Yu N, et al. Predictors of Mechanical Thrombectomy for Anterior Circulation Emergent Large-Vessel Occlusion in the Older Adults. Clin Appl Thromb Hemost. 2023 Jan-Dec;29:10760296231184219. 8. Inoue M, Ota T, Hara T, et al. An Initial High National Institutes of Health Stroke Scale Score and Any Intracranial Hemorrhage Are Independent Factors for a Poor Outcome in Nonagenarians Treated with Thrombectomy for Acute Large Vessel Occlusion: The Tokyo/Tama-REgistry of Acute Endovascular Thrombectomy (TREAT) Study. World Neurosurg. 2022 Sep;165:e325-e30. 9. Ippen FM, Schregel K, Ungerer M, Feisst M, Ringleb PA, Gumbinger CK. Outcomes in elderly patients undergoing endovascular thrombectomy in association with premorbid Rankin Scale scores. Front Neurol. 2024;15:1418415. 10. Yen PS, Kok VC, Lin YH, Wu YT,
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KTGH-IN-24-003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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