Combined Recanalization Therapy for Acute Large Vessel Occlusion Stroke

NCT07115511 | Recruiting DMC

• 2 other identifiers: CRTALVOS2025tianjin Huanhu hospital
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

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

  90 days after recombined recanalization surgery

Secondary Outcomes (4)

• 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;

  90 days after recombined recanalization surgery

• The mRs score changed from baseline at 90 days after surgery

  90 days after recombined recanalization surgery

• Change from baseline in MOCA score at 90 days after surgery

  90 days after recombined recanalization surgery

• Change from baseline in MMSE score at 90 days after surgery

  90 days after recombined recanalization surgery

Study Arms (2)

experiment group（surgical treatment）

EXPERIMENTAL

Procedure: Surgery

control group（conservative therapy）

NO INTERVENTION

Interventions

Surgery PROCEDURE

Recombined recanalization surgery

experiment group（surgical treatment）

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Huanhu Hospital: lead

Study Sites (1)

Tianjin Huahu Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Gao Kaiming

CONTACT

+8618622301400; sunnygao_sg@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DOC.

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 11, 2025
• Study Start: December 1, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: August 11, 2025

Record last verified: 2025-08

Locations

CN (1)