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Stent Graft
Stent Graft for Aortic Dissection
N/A
Waitlist Available
Research Sponsored by W.L.Gore & Associates
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Primary entry tear must be in the ascending aorta and ≥2cm distal to the most distal coronary artery ostia
Adequate vascular access via transfemoral or retroperitoneal approach
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days, 6 months, and 12 months post procedure
Awards & highlights
Study Summary
This trial assesses if a stent graft can be used to treat aortic dissections, a potentially life-threatening medical condition.
Who is the study for?
This trial is for individuals at high surgical risk with DeBakey Type I/II aortic dissection who can follow the study's protocol and undergo CT scans. They must have an aorta size compatible with the GORE® Stent Graft, and not require certain heart procedures within 30 days. Exclusions include drug abuse history, pregnancy, allergies to device materials, previous thoracic surgery, connective tissue diseases, poor imaging due to body habitus or conditions preventing clear visualization of the aorta.Check my eligibility
What is being tested?
The ARISE trial is evaluating how well the GORE® Ascending Stent Graft works in treating DeBakey Type I/II aortic dissections. This involves placing a stent graft within the ascending part of the aorta where there's been separation (dissection) between layers of its wall.See study design
What are the potential side effects?
While specific side effects are not listed here, similar procedures may involve risks like bleeding, infection at access sites, allergic reactions to materials or contrast media used during implantation and potential complications related to placement such as movement or damage to surrounding structures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My aortic tear starts beyond 2cm from where the heart's arteries begin.
Select...
I can have procedures done through my groin or belly area.
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My aortic dissection type fits the treatment with GORE® Stent.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days, 6 months, and 12 months post procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days, 6 months, and 12 months post procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
All Cause Mortality at 30 Days Post-procedure
Secondary outcome measures
Aorta-related Mortality
Endoleak Assessed Through 1 Month, 6 Months, and 12 Months
Individual MACCE Components Through 30 Days, 6 Months, and 12 Months
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: GORE® Ascending Stent GraftExperimental Treatment1 Intervention
Treatment with the GORE® Ascending Stent Graft
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Who is running the clinical trial?
W.L.Gore & AssociatesLead Sponsor
95 Previous Clinical Trials
28,312 Total Patients Enrolled
5 Trials studying Aortic Dissection
835 Patients Enrolled for Aortic Dissection
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My aortic tear starts beyond 2cm from where the heart's arteries begin.I can have a CT scan as needed for planning my procedure.My doctor considers surgery too risky for me.I can have procedures done through my groin or belly area.You have had a bad reaction to heparin in the past.I am scheduled for heart valve surgery or a procedure to unblock my heart's arteries within the next 30 days.You are allergic to blood thinners or contrast dyes and cannot be treated before the study.My aortic dissection type fits the treatment with GORE® Stent.Your body shape or another health condition makes it difficult to see your aorta clearly.You have a history of using drugs in a harmful way.You have other health conditions that are likely to make your life expectancy less than 12 months.I have had surgery on the aorta in my chest.My aortic tear starts in the upper part of my aorta and blood flows backward.You have a permanent brain or nerve injury.I have an infection that could risk a graft infection.I have a condition like Marfan's or Ehler-Danlos Syndrome.You have a mechanical heart valve in the aortic position.Your ascending aorta size is compatible with the GORE® Ascending Stent Graft, and the diameter of the landing zone is between 24mm and 42mm, with a total aortic landing zone diameter of 45mm or less.I have severe aortic valve leakage.
Research Study Groups:
This trial has the following groups:- Group 1: GORE® Ascending Stent Graft
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 available spaces left for individuals to join this examination?
"Unfortunately, clinicaltrials.gov reveals that this trial is not presently recruiting any participants; it was first posted on August 1st 2015 and its information was last updated on February 24th 2023. Nonetheless, 48 other trials are currently inviting individuals to join them in their research efforts."
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