An interventional study of Arcevo™ LSA Hybrid Stent Graft System in Aortic Arch Aneurysm, Aortic Arch Dissection and Chronic Aortic Dissection, sponsored by Artivion Inc.. Recruiting at 26 sites in 3 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Artivion Inc. · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to learn if the Arcevo LSA stent graft can safely and effectively treat patients that have an acute or chronic aortic dissection and/or aneurysm that involves the aortic arch and the descending thoracic aorta, with or without the involvement of the ascending aorta.
27 studies on the registry are indexed under Aneurysm, Aortic Arch; 14 are open to participants now.
This study's planned enrollment of 132 is above the median of 115 across 19 interventional studies indexed under Aneurysm, Aortic Arch.
Browse Aneurysm, Aortic Arch studies →Artivion Inc. is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
General Inclusion Criteria
Patient has one of the following indications for open surgery based on computed tomography angiography (CTA) completed within 90 days of :
Patient's surgery occurs within 90 days of informed consent
Anatomical Inclusion Criteria
General Exclusion Criteria
Patient is currently participating in another interventional clinical study which includes treatment with another product (e.g., device, pharmaceutical or biologic)
Medical Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The Primary study arm will consist of patients with an aortic aneurysm or chronic aortic dissection (n=117). The Secondary study arm will include patients with acute or subacute aortic dissections (n=15).
Device: Arcevo™ LSA Hybrid Stent Graft System
The Arcevo LSA Hybrid Stent Graft System is an implantable aortic stent graft with LSA branch which is preloaded onto a delivery system and implanted during an open surgical procedure, or more specifically a total arch replacement procedure. The device is intended for use with a proximal surgical graft (not supplied). If additional coverage is needed, a protocol specified thoracic endovascular aortic repair (TEVAR) device may be used.
Composite Rate of Patients Free From ≥1 Major Adverse Event
The major adverse events included in the composite are: * All-cause mortality * New permanent disabling stroke * New permanent paraplegia and/or paraparesis * Unanticipated aortic reoperation in the treated segment * LSA occlusion
Time frame: 1 year post-index procedure of LSA stent graft implant
Rate of Mortality
All-cause, Cardiovascular-related, Aorta-related, Procedure-related, Device-related
Time frame: Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure
Rate of Patients with ≥1 Additional Aortic Procedure
All unplanned aortic procedures (endovascular, percutaneous, and open), Unanticipated aortic reoperations in the treated segment, Unanticipated device-related reoperations, Arcevo LSA explant
Time frame: Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure
Rate of Patients with ≥1 Device-Related Event
Device migration, Distal stent-induced new entry (d-SINE), Failed stent patency in the main body, Failed stent patency in the LSA, Stent-graft integrity issue compromising flow (i.e., stent fracture, narrowing, kink, or twist)
Time frame: Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure
Rate of Patients with Major Adverse Events
New permanent paraplegia, New permanent paraparesis, New temporary paraplegia, New disabling stroke, New non-disabling stroke, New transient ischemic attack, Aortic rupture, Bowel ischemia, Hypersensitivity, Myocardial infarction, New onset renal failure requiring temporary dialysis, New onset renal failure requiring permanent dialysis, Pseudoaneurysm, Recurrent laryngeal or phrenic nerve injury, Respiratory failure (need for reintubation or ventilator dependence \>48 hours), Severe heart failure requiring mechanical circulatory support, Thromboembolic adverse events
Time frame: Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure
Rate of Patients with Radiographic Events (determined by Core Lab)
Anastomotic Leak between Arcevo™ LSA and surgical graft (i.e., Type Ia Endoleak or Distal anastomotic new entry \[DANE\]), Type Ic Endoleak (i.e. at the end of the LSA stent component), LSA occlusion, New LSA dissection, Maximal total aortic diameter growth \>1 cm in the treated segment (Zones 2-4) compared to first post-operative CTA, Maximal total aortic diameter growth \>1 cm at 1 cm beyond the distal end of Arcevo™ LSA, compared annually. Dissection Only: True lumen (TL) reduction compared to baseline \> 5.0 mm at maximal total aortic diameter (Zones 2-4), False lumen (FL) growth compared to baseline \> 5.0 mm at maximal total aortic diameter (Zones 2-4), FL thrombosis in the treated segment (LSA, Zones 2-4), FL thrombosis in the untreated segment (Zone 5).
Time frame: Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure
Rate of Patients Requiring a Thoracic Extension Procedure who Experience Device-Extension Failure
Any failure of device-extension integrity (e.g., wear or tear in the fabric or wire breakage) resulting in a compromised seal and blood leakage or movement of the device
Time frame: Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure
Rate of Patient Requiring a Thoracic Extension Procedure with Evidence of Type IIIa Endoleak
Type IIIa Endoleak
Time frame: Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of index procedure
Rate of Patients Requiring Thoracic Extension Procedure with Failed Patency
Failed patency of the device-extension overlap
Time frame: Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure
Rate of Patients Requiring Thoracic Extension Procedure with ≥1 Primary Major Adverse Events
All-cause mortality, new permanent disabling stroke, new permanent paraplegia and/or paraparesis, unanticipated aortic reoperation in the treated segment, LSA occlusion
Time frame: 30 days post-extension procedure
Rate of Patients Requiring Thoracic Extension Procedure Requiring ≥1 Secondary Procedure Related to Extension
Secondary procedures related to the extension
Time frame: 30 days post-extension procedure
Rate of Patients with Technical Success
Successful delivery and accurate placement of the device in the intended implantation site, as well as retrieval of the device delivery system, AND Patency of the device, including LSA, at conclusion of the procedure, AND No need for unanticipated or emergency surgery to correct a device malfunction or device-related complication
Time frame: At exit from operating room
Rate of Patients with Procedural Success
Technical success with the absence of the following: Death, Major adverse ischemic events, including the following: New disabling stroke, New paraplegia, New paraparesis, New device-related ischemia (i.e., not evident at time of index procedure), Distal procedure-related thromboembolic adverse event. General procedure-related complications: New onset renal failure requiring dialysis, Bowel or limb ischemia requiring surgery or intervention, Additional unplanned surgical or interventional procedures related to the device, since completion of the index procedure
Time frame: At hospital discharge or at 30 days, whichever is longer at time of event
Rate of Patients with Treatment Success
Technical success with the absence of the following: Aorta-related mortality. Major adverse ischemic events, including the following: New disabling stroke, New permanent paraplegia, New permanent paraparesis, Increase in total aortic diameter \> 1.0 cm between scheduled post-operative imaging (performed per schedule of activities) in the treated region of the aorta (Zones 2-4), Aortic rupture, Fistula formation (i.e., aortobronchial or aortoenteric), Device-related occlusion of the aortic arch (Zones 2-4), Loss of device integrity (e.g., stent fracture that could affect fixation or seal, graft fabric hole or tear, collapse), New Type Ic endoleak.
Time frame: Follow-up at 30 days, 6, 12, 24, 36, 48, and 60 months of the index procedure
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2025 (actual). Primary completion is estimated for Apr 2028, 29 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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