Chimney EndoVascular Aneurysm Sealing Of New Expanded Indication
-
- STATUS
- Recruiting
-
- End date
- Mar 28, 2028
-
- participants needed
- 120
-
- sponsor
- Endologix
Summary
Prospective, multi-center, non-randomized study with consecutive, eligible subject enrollment at each site, for the evaluation of the ChEVAS System for Endovascular Repair of Complex Abdominal Aortic Aneurysms.
Description
This is a prospective multicenter study with consecutive eligible subject enrollment at each site. Enrollment will include up to 150 subjects (120 ChEVAS subjects and up to 30 infrarenal roll-in subjects). The ChEVAS study will evaluate the safety and effectiveness outcomes following appropriate government and ethics committee/IRB requirements and guidelines.
All enrolled (ChEVAS and Infrarenal) patients will undergo a high resolution, contrast-enhanced computed tomography angiography (CT) scan of the relevant aortic and aortoiliac vasculature within three months of the scheduled procedure and at specified follow-up intervals post-implantation. Follow-up visits will occur at 30-days, 6-months, and annually to 5-years to assess aneurysm morphology, the status of the implanted devices, and relevant laboratory test results.
Details
| Condition | 1 Paravisceral Abdominal Aortic Aneurysm, 2 Juxtarenal Abdominal Aortic Aneurysm, 3 Pararenal Abdominal Aortic Aneurysm, 4 Complex Abdominal Aortic Aneurysms |
|---|---|
| Age | 18-100 years |
| Treatment | Chimney Endovascular Aortic Sealing (ChEVAS) System |
| Clinical Study Identifier | NCT04252573 |
| Sponsor | Endologix |
| Last Modified on | 19 February 2024 |
How to participate?
,
You have contacted , on
Your message has been sent to the study team at ,
What happens next?
- You can expect the study team to contact you via email or phone in the next few days.
- Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.
You are contacting
Primary Contact
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
Learn moreSimilar trials to consider
Not finding what you're looking for?
Sign up as a volunteer to stay informed
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
Sign up as volunteer
Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!
No annotations made yet
Add a private note
- Select a piece of text from the left.
- Add notes visible only to you.
- Send it to people through a passcode protected link.
Study Definition
WikipediaAdd a private note
- Select a piece of text.
- Add notes visible only to you.
- Send it to people through a passcode protected link.