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Completed

NCT Number: NCT06953427

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

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.

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Interventional Neuro-Radiology, Kuang Tien General Hospital

Taichung, 433004, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: Immediate post-thrombectomy

    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.

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

    Time frame: 3-months post-EVT

    Modified Rankin Scale Score Description 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.

Secondary outcomes

  1. Spontaneous intracerebral hemorrhage

    Time frame: Day 2 to Day 90 post-EVT

    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.

Sponsors and collaborators

Lead sponsor

Kuang Tien General Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 1, 2025
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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