Combined Recanalization Therapy for Acute Large Vessel Occlusion Stroke

NCT ID: NCT07115511

Last Updated: 2025-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2026-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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experiment group(surgical treatment)

Group Type EXPERIMENTAL

Surgery

Intervention Type PROCEDURE

Recombined recanalization surgery

control group(conservative therapy)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Surgery

Recombined recanalization surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. 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;
2. unstable angina or myocardial infarction, congestive heart failure within the previous 6 months;
3. Pregnancy or perinatal period;
4. Hematologic disorders resulting in coagulation disorders;
5. Combination of other diseases with a life expectancy of less than 2 years; and
6. previous treatment with intracranial or extracranial vascular bypass surgery;
7. allergy to iodine or X-ray contrast media, creatinine \>3.0 mg/dl or other contraindications to arteriography;
8. Uncontrolled diabetes mellitus, fasting blood sugar (FBS) \>16.7 mmol/L;
9. Uncontrolled hypertension with sitting systolic blood pressure \>180 mmHg or sitting diastolic blood pressure \>110 mmHg;
10. Severe hepatic dysfunction, defined as serum alanine aminotransferase (ALT) and/or alanine aminotransferase (AST) \>3 times the upper limit of normal;
11. Platelets \<100×109 /L.
12. Received a clinical trial drug or device within 30 days prior to screening, or is participating in another clinical trial;
13. contraindication to general anesthesia or craniotomy;
14. other diseases or medical history that, in the investigator's judgment, may affect the efficacy or safety evaluation of this study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Huanhu Hospital

OTHER

Sponsor Role lead

Responsible Party

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Gao Kaiming

DOC.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tianjin Huahu Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Gao Kaiming

Role: CONTACT

+8618622301400

Facility Contacts

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Gao Kaiming

Role: primary

+8618622301400

Other Identifiers

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tianjin Huanhu hospital

Identifier Type: OTHER

Identifier Source: secondary_id

CRTALVOS2025

Identifier Type: -

Identifier Source: org_study_id

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