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NCT Number: NCT07192029

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fujian Medical University Union Hospital, Fuzhou, Fujian, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Balloon guide catheter combined with conventional thrombectomy treatment

Procedure

The experimental group will use balloon guide catheter combined with conventional thrombectomy treatment.

Standard guide catheter or neurovascular sheath combined with conventional thrombectomy treatment

Procedure

use standard guide catheter or neurovascular sheath combined with conventional thrombectomy treatment

Primary outcomes

  1. Rate of first-pass reperfusion defined as eTICI 2c-3 reperfusion

    Time frame: Perioperative

Secondary outcomes

  1. Good outcome proportion, defined as mRS score 0-2

    Time frame: 90 days (±7 days) post-procedure

  2. Ordinal Distribution of mRS Scores (mRS Shift analysis)

    Time frame: 90 days (±7 days)

  3. Change in stroke severity (NIHSS score)

    Time frame: 7 days or discharge (whichever occurs first);

  4. Technical success rate

    Time frame: Perioperative

    Defined as the successful delivery of the guiding catheter to the target vessel and completion of the thrombectomy process without replacing the guiding catheter

  5. Final angiographic reperfusion results (eTICI ≥2b, eTICI ≥2c, eTICI 3)

    Time frame: Perioperative

  6. Reperfusion results (eTICI ≥2b, eTICI 3)

    Time frame: Perioperative

  7. Time from groin puncture to successful reperfusion (eTICI ≥2b, eTICI ≥2c);

    Time frame: Perioperative

  8. Number of mechanical thrombectomy attempts

    Time frame: Perioperative

  9. EQ-5D-5L score

    Time frame: 90 ± 7 days after surgery

  10. Proportion of participants with a Barthel Index score of ≥95

    Time frame: 90 ± 7 days after surgery

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Collaborators

  • Fujian Medical University Union Hospital
  • Zhangzhou Affiliated Hospital of Fujian Medical University

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 25, 2025
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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