Early Feasibility Study of the RelayBranch Thoracic Stent-Graft System (RelayBranch)
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- STATUS
- Recruiting
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- End date
- Aug 31, 2024
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- participants needed
- 30
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- sponsor
- Bolton Medical
Summary
The purpose of this study is to conduct an early clinical evaluation of the Relay Branch System, which will provide initial insight into the clinical safety and function of the device.
This Early Feasibility Study (EFS) will assess the safety and effectiveness of the device at the index procedure and at 30-day follow-up. The study will evaluate the delivery and deployment of the device, patency of branches and branch vessels, and exclusion of the aortic pathology. The data will help determine if modifications need to be made to the device, the procedural steps, operator technique, or the indications for use.
Description
This Early Feasibility Study (EFS) protocol describes the clinical study requirements for the Relay Branch System; a device designed to provide an option for patients with arch and proximal descending chronic thoracic aortic pathologies. As an EFS, this investigation is intended to provide proof of principle and initial clinical safety data on the Relay Branch System. The study is planned as an initial investigation of the device for aortic arch and proximal descending thoracic aortic aneurysmal disease, PAU (including IMH) and uncomplicated chronic Type B aortic dissection (including IMH). The study will yield information on procedural techniques; assessing the safety and effectiveness of the device at the index procedure and at 30 days, focusing on device delivery and deployment, and circulatory exclusion of the pathologic process. As a branched device, patency of the endograft branches will also be assessed.
The study will evaluate three-dimensional (3D) imaging data, both at baseline and through follow-up. Baseline 3D anatomy will augment information on the precise anatomic configuration of patients presenting aortic arch pathology treatable with the device. Follow-up imaging will provide information on the effectiveness of the device with respect to endoleaks in patients with aneurysms, sealing of dissections, PAU and IMH, and stability of the device at the deployed position, response, endograft patency, and short-term device integrity.
The data from this EFS will yield insights into the following aspects of the device, preceding a traditional feasibility or pivotal study:
- The clinical safety of the device-specific aspects of the procedure,
- Determination of delivery and deployment of the device,
- Operator-dependent aspects of device use,
- Human factors associated with the design and use of the device,
- Safety of the device as assessed by device-related adverse events,
- Effectiveness of the device in performing its intended purpose over short-term follow-up.
Observations from the study will guide the instructions for use (IFU) for the device. Finally, the study will collect imaging data to augment the current use conditions data set. It is anticipated that information collected will be used to make applicable design changes, or be combined with a prospective, investigational device exemption (IDE) study for submission of an original premarket approval application (PMA) to the U.S. Food and Drug Administration (FDA) for approval to commercially distribute the system.
Details
| Condition | Thoracic Aorta Aneurysm, Aneurysm, Ruptured, Aortic Aneurysm |
|---|---|
| Treatment | penetrating atherosclerotic ulcer, aorta branch cardiovascular implant |
| Clinical Study Identifier | NCT03214601 |
| Sponsor | Bolton Medical |
| Last Modified on | 4 October 2022 |
Eligibility
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