BridgeMD
New treatment option for Stroke
Official title Combined Recanalization Therapy for Acute Large Vessel Occlusion Stroke
ClinicalTrials.gov ID: NCT07115511
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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;
You likely can't join if
- Comorbid hemorrhagic vascular disease such as intracranial aneurysm or vascular malformation or other planned cerebrovascular surgery that may alter...
- 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;
See the full eligibility 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;
- 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 how well it works or safety evaluation of this study.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.