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

se of ADAPT Assisted by a Compliant Balloon (ADAPT-AB) When ADAPT Fails for Acute Stroke Thrombectomy

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.

Study Overview

• Status: Completed
• Conditions: Ischemic Stroke
• Intervention / Treatment: Device: Compliant balloon

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• France
  • Nice, France, 06000
    • CHU de Nice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients who underwent an endovascular procedure for acute stroke in a single center from November 2018 to February 2020 were included in the study

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Mechanical thrombectomy; Patients who underwent mechanical thrombectomy for large vessel occlusion of the anterior circulation	Device: Compliant balloon; Use of a compliant balloon when ADAPT fails to reach the clot site

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacity to reach the clot site when using an inner balloon	Number of patients for whom the balloon made it possible to reach the clot	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical status at 3 month	Modified Rankin Score	Month 3
Endovascular Complication	Number of dissection or vasospasm when using the balloon	Day 0

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): February 29, 2020
• Study Completion (Actual): May 31, 2020

Study Registration Dates

• First Submitted: June 24, 2021
• First Submitted That Met QC Criteria: June 24, 2021
• First Posted (Actual): June 28, 2021

Study Record Updates

• Last Update Posted (Actual): June 28, 2021
• Last Update Submitted That Met QC Criteria: June 24, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: 21Imagerie01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No