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NCT Number: NCT07115511

Combined Recanalization Therapy for Acute Large Vessel Occlusion Stroke

The purpose of this clinical trial is to evaluate the efficacy and safety of combined recanalization therapy in patients who cannot be recanalized by acute large vessel occlusive stroke. The main questions it aims to answer are:

1、Proportion of subjects with mRs score of 0-1 at 90 days after surgery

Participants will:

1、In acute large vessel occlusive stroke, if traditional means cannot be recanalized, combined recanalization surgery (including arteriotomy and thrombectomy, cerebrovascular bypass surgery) is performed.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tianjin Huahu Hospital

Tianjin, Tianjin Municipality, 300060, China

Location status: Recruiting

Location contact

Gao Kaiming

CONTACT

[email protected]

+8618622301400

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age: 18-75.
  • According to the current guidelines, there is a MT indication.
  • Before stroke, mRS ≤2;
  • ASPECTS ≥6;
  • MCA occlusion, with or without ICA occlusion;
  • MT unsuccessful, TICI score 0-1;
  • Time from onset to craniotomy expected to be 24 hours or less;
  • Post-awakening stroke with mismatch between the infarct zone and the penumbra zone;

Exclusion criteria

  • Comorbid hemorrhagic vascular disease such as intracranial aneurysm or vascular malformation or other planned cerebrovascular surgery that may alter cerebral hemodynamics or lead to stroke;
  • unstable angina or myocardial infarction, congestive heart failure within the previous 6 months;
  • Pregnancy or perinatal period;
  • Hematologic disorders resulting in coagulation disorders;
  • Combination of other diseases with a life expectancy of less than 2 years; and
  • previous treatment with intracranial or extracranial vascular bypass surgery;
  • allergy to iodine or X-ray contrast media, creatinine >3.0 mg/dl or other contraindications to arteriography;
  • Uncontrolled diabetes mellitus, fasting blood sugar (FBS) >16.7 mmol/L;
  • Uncontrolled hypertension with sitting systolic blood pressure >180 mmHg or sitting diastolic blood pressure >110 mmHg;
  • Severe hepatic dysfunction, defined as serum alanine aminotransferase (ALT) and/or alanine aminotransferase (AST) >3 times the upper limit of normal;
  • Platelets <100×109 /L.
  • Received a clinical trial drug or device within 30 days prior to screening, or is participating in another clinical trial;
  • contraindication to general anesthesia or craniotomy;
  • other diseases or medical history that, in the investigator's judgment, may affect the efficacy or safety evaluation of this study.

Treatment and study plan

Surgery

Procedure

Recombined recanalization surgery

Primary outcomes

  1. Proportion of subjects with mRs score of 0-1 at 90 days after surgery

    Time frame: 90 days after recombined recanalization surgery

Secondary outcomes

  1. Changes in NIHSS score at 24 hours after surgery, 7 days after surgery, 30 days after surgery and 90 days after surgery compared with baseline;

    Time frame: 90 days after recombined recanalization surgery

  2. The mRs score changed from baseline at 90 days after surgery

    Time frame: 90 days after recombined recanalization surgery

  3. Change from baseline in MOCA score at 90 days after surgery

    Time frame: 90 days after recombined recanalization surgery

  4. Change from baseline in MMSE score at 90 days after surgery

    Time frame: 90 days after recombined recanalization surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Gao Kaiming

CONTACT

[email protected]

+8618622301400

Sponsors and collaborators

Lead sponsor

Tianjin Huanhu Hospital

Other

Registry information

Acronym: CRTALVOS

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 11, 2025
Registry last updated
Aug 11, 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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