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New treatment option for Stroke
Official title Balloon Guide Catheter to Optimize Outcomes in Stroke Thrombectomy of the Internal Carotid Artery
ClinicalTrials.gov ID: NCT07192029
What this study is testing
- What it's testing
- To investigate whether using balloon guide catheter with flow arrest during mechanical thrombectomy, compared to non-flow arrest, improves the rate of first pass expanded Thrombolysis in Cerebral Infarction score (eTICI 2c-3) reperfusion for acute ischemic stroke due to internal carotid artery occlusion
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- age ≥18 years;
- Clinical diagnosis of acute ischemic stroke with internal carotid artery occlusion confirmed by imaging (CTA/MRA/DSA), including isolated...
- Baseline NIHSS≥6, and meeting local guidelines for mechanical thrombectomy;
- Time from onset or last known normal to randomization within 24 hours and proceeding to mechanical thrombectomy;
- Signed informed consent (or by legal representative).
You likely can't join if
- Pre-stroke mRS score \>2
- Intracranial hemorrhage shown on imaging;
- Known or suspected internal carotid artery occlusion caused by dissection or atherosclerosis;
- Vascular tortuosity preventing the use of balloon guide catheter;
- Prior stent implantation in the target vessel that would impede the use or removal of mechanical thrombectomy devices;
- Any other circumstances impeding mechanical thrombectomy implementation;
See the full eligibility criteria
- age ≥18 years;
- Clinical diagnosis of acute ischemic stroke with internal carotid artery occlusion confirmed by imaging (CTA/MRA/DSA), including isolated intracranial internal carotid artery (I-type), internal carotid artery...
- Baseline NIHSS≥6, and meeting local guidelines for mechanical thrombectomy;
- Time from onset or last known normal to randomization within 24 hours and proceeding to mechanical thrombectomy;
- Signed informed consent (or by legal representative).
- Pre-stroke mRS score \>2
- Intracranial hemorrhage shown on imaging;
- Known or suspected internal carotid artery occlusion caused by dissection or atherosclerosis;
- Vascular tortuosity preventing the use of balloon guide catheter;
- Prior stent implantation in the target vessel that would impede the use or removal of mechanical thrombectomy devices;
- Any other circumstances impeding mechanical thrombectomy implementation;
- Acute occlusion of multiple vascular territories in bilateral anterior circulation or in both the anterior and posterior circulations confirmed by CTA/MRA;
- Pregnant people;
- people allergic to contrast agents;
- people refusing to cooperate or unable to tolerate treatment procedures;
- people whose expected lifetime are less than 90 days;
- Midline shift or herniation with ventricular mass effect;
- people deemed unable to participate in follow-up by investigators;
- Other situations deemed unsuitable for balloon guide catheter use by investigators.
The study team makes the final eligibility decision.
Where it's taking place
- Fuzhou, Fujian, China
- Zhangzhou, Fujian, China
- Beijing, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fuzhou, Fujian, China; Zhangzhou, Fujian, China; Beijing, China. Enter your location above to see the nearest site and check your eligibility.
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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.