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

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04942795
• Other study ID #: 21Imagerie01
• Status: Completed
• Start date: November 1, 2018
• Est. completion date: May 31, 2020

Study information

• Verified date: June 2021
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 31, 2020
• Est. primary completion date: February 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke

Intervention

Device:
• Compliant balloon
Use of a compliant balloon when ADAPT fails to reach the clot site

Locations

Country	Name	City	State
France	CHU de NICE	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical status at 3 month	Modified Rankin Score	Month 3
Secondary	Endovascular Complication	Number of dissection or vasospasm when using the balloon	Day 0