Aortic DissectionTRIOMPHENCT04471909
NEXUS Aortic Arch Clinical Study to Evaluate Safety and Effectiveness
A study testing NEXUS Aortic Stent Graft System in people with Aortic Dissection and Aortic Aneurysm, run by Endospan Ltd. at 32 sites in 2 countries.
Trial summary
Prospective, non-randomized, multi-center clinical investigation of the NEXUS™ Aortic Arch Stent Graft System (NEXUSTM) for the treatment of thoracic aortic lesions involving the aortic arch with a proximal landing zone, native or previously implanted surgical graft, in the ascending aorta and with a brachiocephalic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Dissection, Aortic Aneurysm, Intramural Hematoma
- What is being tested?
- NEXUS Aortic Stent Graft System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 32 sitesin 2 countries
- Study dates
- 20 Oct 2020to Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female age ≥ 18.
- Proximal/ascending native or previously implanted surgical graft landing zone of appropriate length
- Proximal/ascending native or previously implanted surgical graft landing zone of appropriate diameter
- Distal/descending native landing zone of appropriate length
- Distal/descending native landing zone of appropriate diameter
- Brachiocephalic trunk native landing zone of appropriate length
Show all 35Show fewer
- Brachiocephalic trunk native landing zone of appropriate diameter
- Appropriate take off angle between the Brachiocephalic Artery and the Aortic Arch perpendicular
- Appropriate aortic arch perpendicular diameter
- Chronic dissection with at least one of the following conditions:
- An aortic aneurysm with a maximum diameter ≥ 55 mm
- Rapidly expanding false lumen (growth of > 0.5 cm/6 months)
- Compressed true lumen associated with end organ malperfusion
- Symptomatic
- Aneurysm with at least one of the following conditions:
- Dilatation of the aortic arch larger than 5 cm in diameter for subject with fusiform aneurysm
- Dilatation of the aortic arch is 1.5 times the normal diameter for subjects ascending or descending
- Dilation of the aortic arch larger than 2.5 cm for subject with saccular aneurysm
- Symptomatic aneurysm of the aortic arch
- Aortic diameter growth rate > 5mm per 6 months
- Postoperative pseudoaneurysm expanding from anastomotic suture lines
- Penetrating aortic ulcer with at least one of the following:
- Symptomatic
- Ulcer demonstrates expansion
- Intramural hematoma with at least one of the following:
- Symptomatic (persistent pain)
- Transverse or longitudinal expansion on serial imaging
- In the event of a lesion in the ascending aortic, the proximal/ascending native or previously implanted surgical graft the landing zone must be appropriate
- Femoral / iliac artery diameter as documented by CTA or MRA that allows endovascular access to the diseased site with a 20 Fr. delivery catheter.
- Access vessels morphology suitable for endovascular repair in terms of tortuosity, calcification and angulation, documented by CTA/MRA.
- Brachial/Axial Artery diameter that allows endovascular access suitable for 7 Fr.
- Subject is considered an appropriate candidate for an elective surgery.
- Subject is considered to be at high risk for open repair, as determined by the investigator.
- Access vessels, iliac/femoral \& brachial/axillary compatible with vascular access techniques (femoral cutdown or percutaneous), devices, and /or accessories.
- Subject is willing and able to comply with procedures specified in the protocol and is able to return for follow-up visits as specified by the protocol.
Who cannot join
- Acute dissection
- Lesions that can be safely treated with TEVAR landing in zone 2 (with or w/o LSA vascularization)
- Required emergent treatment, e.g., trauma, rupture
- Acute vascular injury of the aorta due to trauma
- Aortic rupture or unstable aneurysm
- Received a previous stent or stent graft in the treated area (including planned landing area)
Show all 31Show fewer
- Required surgical or endovascular treatment of an infra-renal aneurysm at time of implantation
- Planned major surgical or interventional procedure at time of screening, to be performed after the NEXUS™ implantation.
- Any major surgical or interventional procedure 6 weeks before the NEXUS™ implantation, exclusive of planned procedures that are needed for the safe and effective placement of the stent graft (e.g. supra-aortic bypass).
- Subject has had a myocardial infarction (MI) or cerebral vascular accident (CVA) within 90 days prior to the planned implantation
- Subjects with severe aortic valvular insufficiency as determined by echocardiography
- Mechanical valve that preclude safe delivery of NEXUS™
- Known Connective tissue disease (e.g., Marfan's or Ehler's-Danlos syndromes)
- Subject has an active systemic infection at the time of the procedure documented by pain, fever, drainage, positive culture
- Pregnant
- Life expectancy of less than 2 years
- Unsuitable vascular anatomy
- Subject who have a previously implanted surgical wrap of the ascending aorta
- Any medical condition that, according to the investigator's decision, might expose the subject to increased risk by the investigational device or procedure.
- An aneurysm that is mycotic, inflammatory or suspected to be infected.
- Subject with hostile groins/axilla (scarring, obesity, or previous failed puncture) unless conduit are used.
- Subjects with severe atherosclerosis, severe calcification or extensive intraluminal thrombus of the aorta or in the brachiocephalic trunk
- Subject is suffering from unstable angina or NYHA classification III and IV.
- Subject has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to pre-treatment.
- Subject with a contraindication to undergo angiography
- Subject with known sensitivities or allergies to the device materials (including Nitinol [NiTi], polyester fabric [PET], tantalum [TA])
- Clinical conditions that severely inhibit x-ray visualization of the Aorta.
- Subject has history of bleeding diathesis or coagulopathy that may limit the use of dual antiplatelet or anticoagulant therapy by the decision of the investigator
- Acute renal failure; chronic renal failure (excluding dialysis); Creatinine > 2.00 mg/dl
- Any other medical, social, or psychological issues that in the opinion of the investigator preclude them from receiving this treatment, or the procedures and evaluations pre- and post- treatment.
- Active participation in another clinical study that has not completed primary endpoint(s) evaluation or that clinically interferes with the endpoints in this study, or subject is planning to participate in such study prior to the completion of this study.
Trial locations and contacts
32 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
32 sites in 2 countries
United States31 sites, 24 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Jessica Woodford, jesstw@med.umich.edu
Himanshu Patel, M.D
- Recruiting
Emory University
Atlanta, Georgia, 30322
Shaneka Douglas, shaneka.douglas@emory.edu
Bradley Leshnower, M.D
- Recruiting
University of Colorado
Aurora, Colorado, 80045
Tien Ngo, tien.ngo@cuanschutz.edu
Brett Reece, M.D.
- Recruiting
University of Maryland
Baltimore, Maryland, 21201
Kaitlyn Masih, kmasih@som.umaryland.edu
Howard Massey, M.D
- Recruiting
University of Alabama Birmingham
Birmingham, Alabama, 35294
Rebecca St. John, rstjohn@uabmc.edu
Adam Beck, M.D
- Completed
Tufts Medical Center
Boston, Massachusetts, 02111
- Completed
Ascension St. Vincent
Carmel, Indiana, 46290
- Recruiting
University of North Carolina
Chapel Hill, North Carolina, 27599
Rebekah Roten, rebekah_roten@med.unc.edu
Federico Parodi
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Natalie Koren, korenn@musc.edu
Sanford Zeigler, M.D.
- Recruiting
Atrium Health
Charlotte, North Carolina, 28203
Madelyn Smyth, Madelyn.Smyth@advocatehealth.org
Frank Arko, M.D.
- Recruiting
The University of Chicago
Chicago, Illinois, 60637
MacKenton Johnson, mackenton@bsd.uchicago.edu
Trissa Babrowski, M.D
- Recruiting
The Lindner Research Center
Cincinnati, Ohio, 45219
Michael Weber, michael.weber@thechristhospital.com
Geoffrey Answini, M.D.
- Recruiting
University Hospitals of Cleveland
Cleveland, Ohio, 44106
Terence Semenec, Terence.Semenec@UHhospitals.org
Jae Cho
- Completed
Duke University Medical Center
Durham, North Carolina, 27710
- Recruiting
Hartford Hospital
Hartford, Connecticut, 06102
Vicky Macleod, Vicky.Macleod@hhchealth.org
Mohiuddin Cheema
- Completed
Ballad Health
Kingsport, Tennessee, 37660
- Recruiting
University of California San Diego Medical Center
La Jolla, California, 92037
Kathleen Groh, kagroh@health.ucsd.edu
John Lane, M.D.
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Lisa Slinger, lisa.slinger@vumc.org
Ashish Shah
- Recruiting
The Mount Sinai Medical Center
New York, New York, 10029
Catherine Marin, Catherine.Marin@mountsinai.org
Rami Tadros
- Recruiting
Northwell Health Lenox Hill Hospital
New York, New York, 10075
Nhan Tran, nnguyentran@northwell.edu
Derek Brinster, M.D
- Recruiting
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Amanda Anderson, aganders@sentara.com
Christopher Barreiro, M.D.
- Completed
Advent Health Orlando
Orlando, Florida, 32804
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Elizabeth Durham, elizabeth.durham@pennmedicine.upenn.edu
Nimesh Desai, M.D.
- Recruiting
Baylor Scott and White
Plano, Texas, 75093
Niat Tekle, Niat.Tekle@BSWHealth.org
William Brinkman, M.D
- Recruiting
Oregon Health
Portland, Oregon, 97239
Amie Lorisch, lorischa@ohsu.edu
Castigliano Bhamidipati, M.D.
- Recruiting
Carilion Clinic
Roanoke, Virginia, 24014
Yili Zhong, yzhong@carilionclinic.org
Esmaeel Dadashzadeh
- Completed
UC Davis Health
Sacramento, California, 95817
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Laura McDonald, m.laura@wustl.edu
Luis Sanchez, M.D
- Recruiting
Stanford University School of Medicine
Stanford, California, 94305
Tiffany Koyano, 650-724-6921, tkoyano3@stanford.edu
Claire Watkins, M.D.
- Recruiting
MedStar Washington Hospital
Washington D.C., District of Columbia, 20010
Suman Singh, suman.singh@medstar.net
Steven Abramowitz, M.D
- Completed
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096
New Zealand1 site, 1 recruiting
- Recruiting
Auckland City Hospital
Auckland, Grafton, 1023
Courtney Armstrong, CourtneyAr@adhb.govt.nz
Andrew Holden, Prof.
About this study
Official title: A Multi-arm, Multi-Center, Non-Randomized, Prospective, Clinical Study to Evaluate the Safety and Effectiveness of the NEXUS Aortic Arch Stent Graft System in Treating Thoracic Aortic Lesions Involving the Aortic Arch
Prospective, non-randomized, multi-center clinical investigation of the NEXUS™ Aortic Arch Stent Graft System (NEXUSTM) for the treatment of thoracic aortic lesions involving the aortic arch with a proximal landing zone, native or previously implanted surgical graft, in the ascending aorta and with a brachiocephalic trunk native landing zone.
- Being tested
- NEXUS Aortic Stent Graft System
- Medical subject headings
- Aortic Dissection, Aortic Aneurysm, Penetrating Atherosclerotic Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEXUS Aortic Stent Graft SystemDevice
Arch Stent Graft, whose cranial narrow end is intended to be deployed into the Brachiocephalic artery and whose distal end is intended to be deployed into the Descending Thoracic Aorta.
Ascending Stent Graft intended to be deployed in the Ascending Aorta.
OPTIONAL: Descending Extension can be used in case the aortic lesion elongates further distally and out of the covered length offered by the Arch Stent Graft. Multiple Descending Extensions can be used if needed to cover the entire length of the lesion.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Dissection (arm closed to enrollment) | Experimental | Not described Receives: Device: NEXUS Aortic Stent Graft System |
| Penetrating Aortic Ulcer and/or Intramural Hematoma | Experimental | Not described Receives: Device: NEXUS Aortic Stent Graft System |
| Aneurysm (arm closed to enrollment) | Experimental | Not described Receives: Device: NEXUS Aortic Stent Graft System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Technical Failure
- Failure to accurately deliver, track and deploy all required endovascular device components at the intended implantation site and failure to retrieve the device delivery systems without the need for unplanned additional procedures
- Device occlusion
- Failed exclusion of primary entry tear
- Additional unanticipated surgical or interventional procedure related to the device or procedure, to prevent life-threatening or permanent disabling event.
Measured: 30 Days
Clinical Failure
Subjects experiencing early mortality or at least one of the following MAEs through 30-Day of Phase 1 Procedure and 30-Day of Index Procedure: Disabling stroke, permanent paralysis/paraplegia, renal failure, aortic rupture, development of new dissections in the thoracic aorta or brachiocephalic artery.
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start20 Oct 2020
- Primary completionOct 2025 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic DissectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Endospan Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04471909
- Sponsor's protocol ID
- CIP-009
- Acronym
- TRIOMPHE
- Status last verified
- Oct 2025
- First submitted
- 9 Jul 2020
- Last updated
- 20 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-arm, Multi-Center, Non-Randomized, Prospective, Clinical Study to Evaluate the Safety and Effectiveness of the NEXUS Aortic Arch Stent Graft System in Treating Thoracic Aortic Lesions Involving the Aortic Arch
- ClinicalTrials.gov ID
- NCT04471909
- Acronym / sponsor ID
- TRIOMPHE / CIP-009
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Endospan Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 15 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, non-randomized, multi-center clinical investigation of the NEXUS™ Aortic Arch Stent Graft System (NEXUSTM) for the treatment of thoracic aortic lesions involving the aortic arch with a proximal landing zone, native or previously implanted surgical graft, in the ascending aorta and with a brachiocephalic trunk native landing zone.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chronic Dissection (arm closed to enrollment) | Experimental | Device: NEXUS Aortic Stent Graft System |
| Penetrating Aortic Ulcer and/or Intramural Hematoma | Experimental | Device: NEXUS Aortic Stent Graft System |
| Aneurysm (arm closed to enrollment) | Experimental | Device: NEXUS Aortic Stent Graft System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (35 listed)
- Male and female age ≥ 18.
- Proximal/ascending native or previously implanted surgical graft landing zone of appropriate length
- Proximal/ascending native or previously implanted surgical graft landing zone of appropriate diameter
- Distal/descending native landing zone of appropriate length
- Distal/descending native landing zone of appropriate diameter
Key exclusion criteria (31 listed)
- Acute dissection
- Lesions that can be safely treated with TEVAR landing in zone 2 (with or w/o LSA vascularization)
- Required emergent treatment, e.g., trauma, rupture
- Acute vascular injury of the aorta due to trauma
- Aortic rupture or unstable aneurysm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NEXUS Aortic Stent Graft SystemArch Stent Graft, whose cranial narrow end is intended to be deployed into the Brachiocephalic artery and whose distal end is intended to be deployed into the Descending Thoracic Aorta. Ascending Stent Graft intended to be deployed in the Ascending Aorta. OPTIONAL: Descending Extension can be used in case the aortic lesion elongates further distally and out of the covered length offered by the Arch Stent Graft. Multiple Descending Extensions can be used if needed to cover the entire length of the lesion. | Device | Aneurysm (arm closed to enrollment), Chronic Dissection (arm closed to enrollment), Penetrating Aortic Ulcer and/or Intramural Hematoma |
Primary outcome
Device Technical Failure
Time frame: 30 Days
* Failure to accurately deliver, track and deploy all required endovascular device components at the intended implantation site and failure to retrieve the device delivery systems without the need for unplanned additional procedures * Device occlusion * Failed exclusion of primary entry tear * Additional unanticipated surgical or interventional procedure related to the device or procedure, to prevent life-threatening or permanent disabling event.
Clinical Failure
Time frame: 30 Days
Subjects experiencing early mortality or at least one of the following MAEs through 30-Day of Phase 1 Procedure and 30-Day of Index Procedure: Disabling stroke, permanent paralysis/paraplegia, renal failure, aortic rupture, development of new dissections in the thoracic aorta or brachiocephalic artery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
Related trials for Aortic Dissection
Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm
Active, not recruiting
GORE® Ascending Stent Graft in the Treatment of De Novo Type A Aortic Dissections
Aortic Dissection
Recruiting
GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
Aortic Arch Dissection, Aortic Arch Aneurysm
RecruitingObservational study
Potential Diagnostic Biomarkers for Aortic Dissection in the Emergency Department
Aortic Dissection
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
32 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NEXUS Aortic Stent Graft System in people with Aortic Dissection and Aortic Aneurysm, run by Endospan Ltd. at 32 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 35 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Kleine (+1 (612) 280-0208, j.kleine@endospan.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Technical Failure (time frame: 30 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2025.