AzTrials
AzTrials

Acute Cerebral IschemiaNCT06953427

The Impact of Age on Short-term Post-thrombectomy Outcomes in Patients Aged 70 or Beyond With Acute Ischemic Stroke

An observational study of Acute Cerebral Ischemia and Endovascular Thrombectomy, run by Kuang Tien General Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

A recent Cochrane systematic review of 18 randomized controlled trials (RCTs) comparing endovascular intervention-either mechanical thrombectomy or intra-arterial thrombolysis combined with medical treatment-to conservative medical treatment alone provided high-certainty evidence that endovascular intervention… Read more about this study

Who is it for?
Ages 70 years and older
How many people
94 participants
Where
1 siteTaiwan
Study dates
1 Feb 2025to 15 Apr 2025
Phase
Observational
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 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: Single-center cohort of patients aged ≥70 years with AIS who underwent EVT at Kuang Tien General Hospital, Taichung, Taiwan.

Who may be able to join

  • 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.

Who cannot join

  • Premorbid mRS score >2
  • Poor imaging quality precluding assessment
  • Lack of follow-up data.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Department of Interventional Neuro-Radiology, Kuang Tien General Hospital

    Taichung, 433004

Other trials in Taiwan

About this study

A recent Cochrane systematic review of 18 randomized controlled trials (RCTs) comparing endovascular intervention-either mechanical thrombectomy or intra-arterial thrombolysis combined with medical treatment-to conservative medical treatment alone provided high-certainty evidence that endovascular intervention increases the likelihood of achieving a favorable functional outcome (modified Rankin Scale [mRS] score of 0-2) by 50% in patients with acute ischemic stroke (AIS).1 More recently, a cross-Atlantic RCT was conducted to determine whether endovascular therapy (EVT) plus medical care is superior to medical care alone in patients with acute proximal cerebral vessel occlusion in the anterior circulation and large infarcts, regardless of infarct size. The study confirmed a 63% increased odds of a favorable outcome with EVT plus medical care. In real-world registries of EVT for AIS due to large-vessel occlusion in the anterior circulation, approximately one-half of patients are aged 70 and older, while 13% to 39% are aged 80 and beyond. In patients aged 70 and beyond who are EVT-eligible, post-procedure mortality increases progressively with increasing age. A prospective European study found that each additional year of age was associated with an 8% decline in the likelihood of achieving a favorable functional outcome. In elderly patients, increasing age is more than just a number-it reflects a higher likelihood of significant medical comorbidities, polypharmacy, declining functional status, compromised nutritional status, and weakened immune function. Research on age as a predictor of EVT outcomes often compares elderly patients to much younger counterparts. However, contrasting post-EVT outcomes in older adults with those under 70 is neither realistic nor appropriate due to inherent differences in baseline health, comorbidities, and physiological resilience. Therefore, the investigators analyzed a prospectively registered cohort to assess whether age influences post-EVT functional outcomes, using septuagenarians as the control group.

Read the detailed description

This is a retrospective, single-center cohort study evaluating patients aged ≥70 years with AIS who underwent EVT at Kuang Tien General Hospital, Taichung, Taiwan. A registry has been established by the Department of Interventional Neuroradiology under the supervision by Dr. Pao-Sheng Yen. for patients who The stroke center is nationally accredited for its capability to evaluate and perform EVT for acute ischemic stroke emergencies. The study was approved by the Institutional Review Board (IRB) with an approval certificate numbered KTGH-11415, and informed consent was waived due to the retrospective nature of the study.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06953427
Study groupRoleWhat they receive
Patients with acute cerebral stroke who underwent endovascular thrombectomyOnly patients who aged 70 or above will be enrolled.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Post-endovascular thrombectomy modified Thrombolysis in Cerebral Infarction (mTICI) reperfusion grade

    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.

    Measured: Immediate post-thrombectomy

  2. Three-months post-EVT modified Rankin scale (mRS)

    Modified Rankin Scale Score Description 0: No symptoms at all;

    1. No significant disability despite symptoms; able to carry out all usual duties and activities;
    2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance;
    3. Moderate disability; requiring some help, but able to walk without assistance;
    4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance;
    5. Severe disability; bedridden, incontinent, and requiring constant nursing care and attention;
    6. Dead.

    Measured: 3-months post-EVT

Secondary outcomes (1)

  1. Spontaneous intracerebral hemorrhage

    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.

    Measured: Day 2 to Day 90 post-EVT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2025
  2. Study start1 Feb 2025
  3. Primary completion15 Apr 2025
  4. Study completion15 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06953427
Sponsor's protocol ID
KTGH-IN-24-003
Status last verified
Apr 2025
First submitted
16 Apr 2025
Last updated
1 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Most of the relevant clinical characteristics will be reported as aggregate data.

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,

  • Yen PS, Kok VC, Lin YH, Ko LY. Age demonstrates limited predictive utility for functional outcomes after thrombectomy in patients aged >/=70 years with acute ischemic stroke: a single-center cohort study. Front Neurol. 2026 Apr 2;17:1772084. doi: 10.3389/fneur.2026.1772084. eCollection 2026.

    PubMed 42004430

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Cerebral Ischemia and Endovascular Thrombectomy, run by Kuang Tien General Hospital at 1 site in Taiwan.

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 4 inclusion and 3 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 1 May 2025. 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 Taiwan. 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?

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?

Post-endovascular thrombectomy modified Thrombolysis in Cerebral Infarction (mTICI) reperfusion grade (time frame: Immediate post-thrombectomy). 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 NCT06953427, which also lists 2 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 1 May 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in