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Stent Graft System
NEXUS Stent Graft for Aortic Disease (TRIOMPHE Trial)
N/A
Recruiting
Research Sponsored by Endospan Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Intramural hematoma with specific conditions
Proximal/ascending native or previously implanted surgical graft landing zone of appropriate diameter
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
TRIOMPHE Trial Summary
This trial is testing a new stent graft system for treating aortic arch lesions. The stent graft will have a proximal landing zone in the ascending aorta and a brachiocephalic trunk native landing zone.
Who is the study for?
This trial is for adults over 18 with certain aortic conditions like aneurysms or dissections, who are high-risk candidates for open surgery. They must have suitable anatomy for the NEXUS Stent Graft System and be able to follow study procedures. Pregnant individuals, those with recent major surgeries or heart attacks, severe infections, or known allergies to device materials cannot participate.Check my eligibility
What is being tested?
The NEXUS Aortic Arch Clinical Study tests the safety and effectiveness of the NEXUS Aortic Stent Graft System in treating thoracic aortic lesions involving the arch. It's non-randomized and multi-center, focusing on patients with specific anatomical features suitable for this elective endovascular repair procedure.See study design
What are the potential side effects?
Potential side effects may include complications related to stent grafts such as movement of the stent after placement, blockage or narrowing at the site where it's implanted (stenosis), injury to access vessels during insertion, bleeding due to anticoagulants used during implantation, and general risks associated with endovascular procedures.
TRIOMPHE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a blood clot within the walls of my blood vessels.
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My heart surgery area is the right size for a new procedure.
Select...
I have an aneurysm with specific conditions.
Select...
I have a penetrating ulcer in my aorta.
Select...
My blood vessels are suitable for certain surgical procedures.
Select...
I have a long-term tear in my blood vessel wall.
TRIOMPHE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical Failure
Device Technical Failure
TRIOMPHE Trial Design
3Treatment groups
Experimental Treatment
Group I: Penetrating Aortic Ulcer and/or Intramural HematomaExperimental Treatment1 Intervention
Group II: Chronic DissectionExperimental Treatment1 Intervention
Group III: AneurysmExperimental Treatment1 Intervention
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Who is running the clinical trial?
Endospan Ltd.Lead Sponsor
5 Previous Clinical Trials
86 Total Patients Enrolled
2 Trials studying Aortic Aneurysm
48 Patients Enrolled for Aortic Aneurysm
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have scarring, obesity, or previous failed puncture in the groin or armpit area, unless other methods are used for the procedure.The lower part of the main blood vessel where the device will be placed should be long enough.I have a blood clot within the walls of my blood vessels.You have a known connective tissue disease such as Marfan's or Ehlers-Danlos syndromes.My artery size is suitable for a specific medical procedure.I am scheduled for a major surgery after getting a NEXUS™ implant.You are not expected to live for more than 2 years.Your blood vessels need to be the right shape for a certain type of repair, as seen in a special type of imaging test.I have severe heart problems, including unstable chest pain.You have a medical condition that makes it really hard to see your aorta in an x-ray.I currently have an infection with symptoms like pain, fever, or drainage.I have severe hardening or blockage in my heart's arteries.I cannot have an angiography due to health risks.I needed emergency treatment for a sudden, severe condition.Your femoral or iliac artery is big enough for a special tube to be inserted during the procedure.I need surgery for a lower stomach artery bulge.Your arm or chest artery is big enough for a 7 Fr catheter to be inserted.My heart surgery area or graft is the right size for another procedure.I have a bleeding or clotting disorder that may affect my treatment.My heart surgery area is the right size for a new procedure.I can follow the study's procedures and attend all follow-up visits.I haven't had major surgery or procedures in the last 6 weeks, except for those necessary for safe stent placement.I have an aneurysm with specific conditions.You are allergic to the materials used in the device, such as Nitinol, polyester fabric, or tantalum.My kidney function is impaired with a creatinine level over 2.00 mg/dl.My heart's main artery has enough space for treatment.I have a penetrating ulcer in my aorta.The doctor thinks that you are at high risk for a certain type of surgery.I had a heart attack or stroke within the last 3 months.My blood vessels are suitable for certain surgical procedures.My condition allows for a specific type of artery repair in my chest.My aneurysm is caused by an infection.I have had surgery involving a wrap around my ascending aorta.I am 18 years old or older.I have a long-term tear in my blood vessel wall.I have an injury to my aorta from an accident.I have an acute dissection.The width of your aortic arch is within the correct range.I am deemed fit for planned surgery.I have severe aortic valve issues confirmed by an echo test.You have a mechanical heart valve that may prevent the safe use of NEXUS™.My blood vessels are not suitable for certain medical procedures.My heart's lower landing zone is the right size for treatment.My heart's main artery has a normal connection angle.I do not have a ruptured aorta or an unstable aneurysm.You have had a stent or stent graft placed in the area that will be treated in this study.
Research Study Groups:
This trial has the following groups:- Group 1: Chronic Dissection
- Group 2: Penetrating Aortic Ulcer and/or Intramural Hematoma
- Group 3: Aneurysm
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 participants being actively sought for this clinical experiment?
"According to clinicaltrials.gov, this research study is currently recruiting participants and has been since October 20th 2020. The trial was last updated on June 13th 2022."
Answered by AI
How many participants is the trial allowing to enroll?
"The sponsor for this research, Endospan Ltd., is recruiting 100 participants that match their criteria from two clinics - University of Alabama Birmingham and Baylor Scott and White."
Answered by AI
How many healthcare facilities are conducting this experiment?
"The trial is presently recruiting from 21 different medical centres. These include Birmingham, Plano, and Ann Arbor in addition to other places around the nation. To minimize transportation needs for patients wishing to join this experiment, it is highly recommended that they select a nearby clinic."
Answered by AI
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