NCT06953427

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 16, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 1, 2025

Completed
Last Updated

May 1, 2025

Status Verified

April 1, 2025

Enrollment Period

2 months

First QC Date

April 16, 2025

Last Update Submit

April 23, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    Immediate post-thrombectomy

  • 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.

    3-months post-EVT

Secondary Outcomes (1)

  • Spontaneous intracerebral hemorrhage

    Day 2 to Day 90 post-EVT

Study Arms (1)

Patients with acute cerebral stroke who underwent endovascular thrombectomy

Only patients who aged 70 or above will be enrolled.

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Interventional Neuro-Radiology, Kuang Tien General Hospital

Taichung, 433004, Taiwan

Location

Related Publications (1)

  • 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,

    BACKGROUND

Study Officials

  • Pao-Sheng Yen, MD

    Kuang Tien General Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior attending staff of the Department of Internal Medicine

Study Record Dates

First Submitted

April 16, 2025

First Posted

May 1, 2025

Study Start

February 1, 2025

Primary Completion

April 15, 2025

Study Completion

April 15, 2025

Last Updated

May 1, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Most of the relevant clinical characteristics will be reported as aggregate data.

Locations