Use of a Compliant Balloon for Large Bore Catheter Navigation in Mechanical Thrombectomy for Stroke: a Retrospective Study

Completed

• Conditions: Ischemic Stroke
• Interventions: Device: Compliant balloon

• Registration Number: NCT04942795
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief Summary

The superiority of mechanical thrombectomy (MT) in patients with acute ischemic stroke from large vessel occlusion compared to standard medical therapy alone has been demonstrated by several randomized clinical trials and become the standard of care for these patients. A direct aspiration first pass technique (ADAPT) for the endovascular treatment of stroke using a large-bore catheter has been reported to be an effective method of achieving MT. Recent studies reported that ADAPT is as efficient and safe as stent retrievers, with a similar successful recanalization rate, but may have better functional outcomes, fewer procedure related-adverse events, and a tendency for faster revascularization compared to the stent-retriever thrombectomy.

However, navigation of a large-bore aspiration catheter is not always possible due to unsuccessful passage of the ophthalmic artery origin ("ledge effect") or tortuous vascular anatomy. The coaxial technique comprises guiding the large-bore catheter with a smaller inner catheter and can facilitate distal access. However, there is a gap between the inner catheter and the distal tip of the large-bore outer catheter that creates a risk of damaging the vessel wall and causing dissection or subarachnoid hemorrhage. Even with this coaxial technique, it is not always possible to reach the clot site with the large-bore catheter. To decrease the gap between the two catheters, several authors have used, in place of the inner microcatheter, a compliant balloon catheter positioned and inflated at the distal tip of the large-bore catheter. The aim of the present study was to evaluate the safety and efficacy of ADAPT assisted by a compliant balloon (ADAPT-AB) when ADAPT using the coaxial technique fails to reach the clot site.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-01
• Primary Completion: 2020-02-29
• Study Completion: 2020-05-31
• Status Verified: 2021-06
• Study First Submitted: 2021-06-24
• Study First Submitted QC: 2021-06-24
• Last Update Submitted: 2021-06-24
• Study First Posted: 2021-06-28
• Last Update Posted: 2021-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Endovascular therapy were large arterial occlusions proven by MR angiography,
• Alberta Stroke Program Early CT Score (ASPECTS) >5 on MRI,
• Baseline National Institutes of Health Stroke Scale (NIHSS) score >5.

If eligible, patients received intravenous thrombolysis (IVT).

Exclusion criteria:

• Vertebro-basilar occlusion

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mechanical thrombectomy	Compliant balloon	Patients who underwent mechanical thrombectomy for large vessel occlusion of the anterior circulation

Primary Outcome Measures

Name	Time	Method
Efficacity to reach the clot site when using an inner balloon	Day 0	Number of patients for whom the balloon made it possible to reach the clot

Secondary Outcome Measures

Name	Time	Method
Clinical status at 3 month	Month 3	Modified Rankin Score
Endovascular Complication	Day 0	Number of dissection or vasospasm when using the balloon

Trial Locations

Locations (1)

CHU de NICE; 🇫🇷 Nice, France