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Recruiting NCT07192029

Balloon Guide Catheter to Optimize Outcomes in Stroke Thrombectomy of the Internal Carotid Artery

No phase Interventional Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Balloon guide catheter combined with conventional thrombectomy treatment, Standard guide catheter or neurovascular sheath combined with conventional thrombectomy treatment.
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Balloon Guide Catheter to Optimize Outcomes in Stroke Thrombectomy of the Internal Carotid Artery: a Randomized Controlled Trial

Overview

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

Interventions

  • Procedure Balloon guide catheter combined with conventional thrombectomy treatment
    The experimental group will use balloon guide catheter combined with conventional thrombectomy treatment.
  • Procedure Standard guide catheter or neurovascular sheath combined with conventional thrombectomy treatment
    use standard guide catheter or neurovascular sheath combined with conventional thrombectomy treatment

Primary outcome measures

  • Rate of first-pass reperfusion defined as eTICI 2c-3 reperfusion [Time frame: Perioperative]
Secondary outcome measures (10)
  • Good outcome proportion, defined as mRS score 0-2 [Time frame: 90 days (±7 days) post-procedure]
  • Ordinal Distribution of mRS Scores (mRS Shift analysis) [Time frame: 90 days (±7 days)]
  • Change in stroke severity (NIHSS score) [Time frame: 7 days or discharge (whichever occurs first);]
  • Technical success rate [Time frame: Perioperative]
  • Final angiographic reperfusion results (eTICI ≥2b, eTICI ≥2c, eTICI 3) [Time frame: Perioperative]
  • Reperfusion results (eTICI ≥2b, eTICI 3) [Time frame: Perioperative]
  • Time from groin puncture to successful reperfusion (eTICI ≥2b, eTICI ≥2c); [Time frame: Perioperative]
  • Number of mechanical thrombectomy attempts [Time frame: Perioperative]
  • EQ-5D-5L score [Time frame: 90 ± 7 days after surgery]
  • Proportion of participants with a Barthel Index score of ≥95 [Time frame: 90 ± 7 days after surgery]

Eligibility criteria

Inclusion 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 intracranial segment involving middle cerebral artery (L-type), or internal carotid artery intracranial segment involving middle and anterior cerebral arteries (T-type) (including tandem embolic occlusions of the internal carotid artery C1 or common 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).

Exclusion criteria

  • 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 subjects;
  • Subjects allergic to contrast agents;
  • Subjects refusing to cooperate or unable to tolerate interventional procedures;
  • Subjects whose expected lifetime are less than 90 days;
  • Midline shift or herniation with ventricular mass effect;
  • Subjects deemed unable to participate in follow-up by investigators;
  • Other situations deemed unsuitable for balloon guide catheter use by investigators.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 3 centers
  • Fujian Medical University Union Hospital — Fuzhou
  • Zhangzhou Municipal Hospital — Zhangzhou
  • Xuanwu Hospital, Capital Medical University. — Beijing

Identifiers

NCT: NCT07192029 · IAT-BOOST

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗