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Endovascular Repair
ChEVAS for Abdominal Aortic Aneurysm (ChEVAS One Trial)
N/A
Waitlist Available
Research Sponsored by Endologix
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Abdominal aortic aneurysm (AAA) with specific size criteria
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-year
Awards & highlights
ChEVAS One Trial Summary
This trial will test a new endovascular repair system for complex abdominal aortic aneurysms. Subjects will be enrolled at multiple sites, and the trial will assess the safety and effectiveness of the device.
Who is the study for?
This trial is for adults over 18 with abdominal aortic aneurysms meeting specific size criteria and without significant vessel angulation. Candidates must consent to follow-up visits, not be in other studies within the last 30 days, have no allergies to materials used, or conditions like Marfan Syndrome that could affect results.Check my eligibility
What is being tested?
The study tests the ChEVAS System for repairing complex abdominal aortic aneurysms. It's prospective and non-randomized, meaning all eligible participants at each center get the new treatment without being compared to another group receiving a different treatment.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include complications related to endovascular procedures such as blood vessel damage, infection risk at the incision site, allergic reactions to materials used in the system or contrast media during imaging.
ChEVAS One Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have an abdominal aortic aneurysm of a specific size.
ChEVAS One Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1-year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of Safety and Effectiveness Indicators at One-Year Post-Index Procedure
Proportion of Technical Success, Safety and Effectiveness Indicators at One-Month Post-Index Procedure
ChEVAS One Trial Design
1Treatment groups
Experimental Treatment
Group I: ChEVAS SystemExperimental Treatment1 Intervention
The ChEVAS procedure involves the use of the Nellix System in conjunction with parallel branch chimney stents for the treatment of juxtarenal, pararenal, or paravisceral abdominal aortic aneurysms.
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Who is running the clinical trial?
EndologixLead Sponsor
22 Previous Clinical Trials
3,959 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a stroke or heart attack in the last 3 months.My blood vessels may not allow for safe medical device use.Your blood vessels in your head don't have a significant angle that would make it difficult to insert a tube for treatment.I have an abdominal aortic aneurysm of a specific size.I need oxygen at home.I have a stent in a major artery that could affect new treatment.I am 18 years old or older.You have a connective tissue disease like Marfan Syndrome.Your blood creatinine level is higher than 1.8 mg/dL.
Research Study Groups:
This trial has the following groups:- Group 1: ChEVAS System
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any North American sites involved in this examination?
"This trial is offered at 26 distinct healthcare centres, including the University of California Medical Center in Los Angeles, Phoenix Cardiovascular Research in Phoenix, and Icahn School of Medicine in New york."
Answered by AI
Are there any spots still available to join this experiment?
"As per clinicaltrials.gov, this research is not currently welcoming new participants. Although initially posted on June 29th 2020 and last updated on the 22nd of June 2022, 153 similar trials are open to enrollment right now."
Answered by AI
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