Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06211712

Efficacy and Safety of Human Urinary Kallidinogenase Combined With Endovascular Therapy in Acute Ischemic Stroke With Large Vessel Occlusion

Led by Huashan Hospital · Updated on 2024-12-04

120

Participants Needed

1

Research Sites

84 weeks

Total Duration

On this page

Sponsors

H

Huashan Hospital

Lead Sponsor

S

Shanghai Stroke Association

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this study is to evaluate the safety and efficacy of Human Urinary Kallidinogenase combined with endovascular therapy in acute ischemic stroke (AIS) patients with large vessel occlusion.

CONDITIONS

Official Title

Efficacy and Safety of Human Urinary Kallidinogenase Combined With Endovascular Therapy in Acute Ischemic Stroke With Large Vessel Occlusion

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participant with acute anterior circulation ischemic stroke receiving endovascular treatment within 24 hours (non-bridged).
  • Age 18 years or older.
  • Modified Rankin Scale score was 0-1 before stroke onset.
  • ASPECT score of infarction on emergency CT 7 or higher.
  • Emergency CTA showing acute ischemic stroke with large vessel occlusion (internal carotid artery, M1 or M2 segment of middle cerebral artery).
  • Emergency CTP or DWI showing infarct core volume between 10 mL and less than 100 mL and low perfusion brain tissue volume to infarct core volume ratio greater than 1.2.
  • Willing and able to follow study procedures and sign informed consent (patient or surrogate).
Not Eligible

You will not qualify if you...

  • Severe heart, liver, or kidney dysfunction, coagulation problems, intolerance to surgery, allergy to Human Urinary Kallidinogenase or contrast agents, or other angiographic contraindications.
  • Presence of intracranial hemorrhagic diseases shown by CT or MRI (such as hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage).
  • History of cerebral hemorrhage, brain tumor, brain trauma, or other brain diseases.
  • Regular use of ACEI antihypertensive drugs that cannot be stopped.
  • Major surgery or severe trauma within the past 2 weeks.
  • Poor compliance or inability to fully follow study protocol.
  • Pregnancy or breastfeeding.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Huashan Hospital

Shanghai, China, 200040

Actively Recruiting

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Research Team

Q

Qiang Dong, M.D.

CONTACT

W

Wenjie Cao, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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