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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04942795
Enrollment
100
Registered
2021-06-28
Start date
2018-11-01
Completion date
2020-05-31
Last updated
2021-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke

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.

Interventions

DEVICECompliant balloon

Use of a compliant balloon when ADAPT fails to reach the clot site

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Efficacity to reach the clot site when using an inner balloonDay 0Number of patients for whom the balloon made it possible to reach the clot

Secondary

MeasureTime frameDescription
Clinical status at 3 monthMonth 3Modified Rankin Score
Endovascular ComplicationDay 0Number of dissection or vasospasm when using the balloon

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026