Trials / Terminated
TerminatedNCT05361187
BOBBY™ Balloon Guide Catheter for Endovascular Treatment of Acute Ischemic Stroke
STRAIT: Evaluation of Safety and Performance of the BOBBY™ Balloon Guide Catheter for Endovascular Treatment of Acute Ischemic Stroke
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 171 (actual)
- Sponsor
- Microvention-Terumo, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
Evaluation of the safety and performance of the BOBBY™ Balloon Guide Catheter (BGC) in patients with an acute ischemic stroke treatment, a sudden reduction or termination of the blood circulation of the brain, caused by a clot. Immediate treatment is needed to restore the blood circulation in the brain, performing a mechanical removal of the clot (thrombectomy). To prevent clot particles migrating in other parts of the brain circulation during the thrombectomy, balloon guiding catheters are inserted. The aim of the study is to evaluate the safety and performance of the balloon guide catheter BOBBY™ by collecting information from patients, treated with a mechanical thrombectomy and the balloon guide catheter (BOBBY™) after acute ischemic stroke
Detailed description
The main objective of the STRAIT study is to assess the performance of the mechanical thrombectomy using a BOBBY™ Balloon Guide Catheter (BGC) as adjunctive device for endovascular treatment of patients suffering from an anterior circulation acute ischemic stroke. Interventional procedures and clinical follow-up will be performed per standard of care. Patient health-related and imaging data will be collected as of stroke onset time up to 90 days follow up.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | BOBBY™ Balloon Guide Catheter intended for use in neurovascular procedures, performing or as an adjunctive device | The BOBBY™ BGC used during a mechanical thrombectomy procedure (stent retriever alone, contact aspiration alone or stent retriever and contact aspiration) and according to the instruction for use (IFU). |
Timeline
- Start date
- 2022-04-08
- Primary completion
- 2023-09-30
- Completion
- 2023-12-30
- First posted
- 2022-05-04
- Last updated
- 2025-01-07
Locations
9 sites across 2 countries: Germany, Switzerland
Source: ClinicalTrials.gov record NCT05361187. Inclusion in this directory is not an endorsement.