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| General |
| Study Status |
Study Pending |
Application Number /
Requirement Number |
P250033 / PAS002 |
| Date Original Protocol Accepted |
07/24/2026
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| Date Current Protocol Accepted |
07/24/2026
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| Study Name |
Nexus New Enrollment PAS
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| Device Name |
NEXUS Aortic Arch Stent Graft System
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| Clinical Trial Number(s) |
NCT04471909
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: At least 22 yrs
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| Detailed Study Protocol Parameters |
| Study Objectives |
Prospective, non-randomized, multi-center, single-arm, PAS evaluating subjects treated with NEXUS® device.
The objective of the study is to evaluate long-term real-world safety and effectiveness outcome data on the NEXUS® device and to assess the adequacy of the training program.
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| Study Population |
Subjects who are intended to be treated with NEXUS® device.
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| Sample Size |
Number of subjects: Up to 150 (minimum of 135)
Number of sites: Up to 60 sites globally
Sites location: US and OUS
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| Key Study Endpoints |
Co-Primary Endpoints:
Device Technical Failure (through 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.
Specifically, the below will be counted against the endpoint:
¿ Surgical conversion
¿ Re-intervention to treat migration
¿ Re-intervention to treat stenosis or occlusion
¿ Re-intervention to treat type Ia, Ib, III, IV endoleaks.
¿ Re-intervention for loss of device integrity
Clinical Failure (through 30-Days):
Subjects experiencing at least one of the following MAEs through 30-Day of Phase 1 procedure and 30-Day of Index procedure:
• Lesion Related Mortality • Defined as: Death occurring after the procedure (Phae 1 or Index) or a secondary procedure and attributable to pathology involving the treated aortic segment, including deaths related to device malfunction; aortic rupture of the treated segment, retrograde dissection involving the treated segment, or fistula formation involving the treated segment.
• Disabling Stroke • Defined as: a stroke with a mRS score of two or more at 30 days and an increase in at least one mRS category from an individual’s pre-stroke baseline
• Permanent Paralysis/Paraplegia • Defined as: Spinal Cord Ischemia Scale > 3 (Non-ambulatory and/or wheelchair bound), persisting at least 30 days).
• Renal failure • Defined as: new onset requiring permanent dialysis
• Aortic rupture • Defined as: catastrophic rupture or tear of the aorta as confirmed by new hematoma or pericardial effusion based upon CT, MRI or Echocardiographic imaging.
• Development of new dissections in the thoracic aorta or brachiocephalic artery • Defined as: any great vessel or brachiocephalic artery that clinically requires intervention
Secondary Endpoints:
• The individual elements of the primary endpoints
• Device and procedure-related SAEs
• Access-related complications (Index Procedure only)
• Life Threatening Bleed (Index Procedure only)
• All-cause mortality
• Lesion related mortality
• Neurological Events including Disabling Stroke • All neurological events will be measured for the overall rate along with the rate of disabling stroke reported separately.
• Permanent Paralysis/paraplegia (Starting within 30 days only)
• Myocardial Infarction (within 30 days only)
• Laryngeal or Phrenic Nerve Injury (within 30 days only)
• Development of new dissections proximal or distal to the treatment zone requiring clinical intervention
• Development of new dissections proximal or distal to the treatment zone without clinical intervention
• False lumen status: partially thrombosed, patent, thrombosed, complete thrombosis (chronic dissection cohort only)
• False lumen perfusion source (chronic dissection cohort only)
• Lesion enlargement of treated area
• Endoleaks (Type I, III, IV, V)
• Migration
• Extension of Dissection
• Patency Status
• Loss of stent graft integrity
• Lesion-Related Events
• Conversion to open repair
• All Secondary procedures in the treatment area
• Device-related SAEs
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| Follow-up Visits and Length of Follow-up |
30 days, 6 months, 1 year, annually thereafter through 10 years
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