NCT07170332|Not Yet Recruiting
ZIPPER™ Stent-Graft Trial for Aortic Arch Dissection
Clinical Study on the Safety and Efficacy of the ZIPPER™ Aortic Arch Stent-Graft System in the Treatment of Aortic Arch Dissection
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Clinical Study on the Safety and Efficacy of the ZIPPER™ Aortic Arch Stent-Graft System in the Treatment of Aortic Arch Dissection
Sponsor study identifier
interventional
127
0 countries
N/A
Study Start
September 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 30, 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This study is the feasible study on a new technique of ZIPPER aortic arch stentgraft system
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 5, 2025
Actual (reported)September 12, 2025
Actual (reported)September 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
September 30, 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
30-day major adverse event (MAE)-free rate
Absence of the following events within 30 days post-procedure: All-cause mortality Ischemic stroke Myocardial infarction Renal failure: Defined as requiring persistent dialysis, renal transplantation, or leading to fatal outcomes Respiratory failure: Defined as requiring prolonged intubation (\>72 hours), tracheostomy, pulmonary function deterioration, or leading to fatal outcomes Permanent paraplegia Bowel necrosis: Defined as requiring bowel resection or leading to fatal outcomes Intraoperative blood loss \>1000 mL
30 days after intervention
12-month Clinical Treatment Success Rate
Immediate technical success (intraoperative) Freedom from the following at 12 months post-procedure All-cause mortality. Stent graft migration (confirmed by CTA). Type I or III endoleaks (confirmed by CTA). Loss of branch stent patency (confirmed by imaging or clinical symptoms). Secondary surgical intervention
12 months post-intervention
All-cause mortality rate
Prior to discharge, 30 days, 6 months,12 months, 24-60 months post-procedure
Severe stroke rate (defined as modified Rankin Scale [mRS] score ≥2 at 90 days post-stroke)
Prior to discharge, 30 days, 6 months,12 months, 24-60 months post-procedure
Aortic dissection-related mortality rate
Prior to discharge, 30 days, 6 months,12 months, 24-60 months post-procedure
Major adverse event (MAE) rate
Prior to discharge, 30 days, 6 months,12 months, 24-60 months post-procedure
Device-related adverse event rate
Prior to discharge, 30 days, 6 months,12 months, 24-60 months post-procedure
The ZIPPER aortic arch stentgraft system consists of the arch mainbody stentgraft system, the branch artery stentgraft system and the thoracic extension stentgraft system.
The ZIPPER aortic arch stentgraft system consists of the arch mainbody stentgraft system, the branch artery stentgraft system and the thoracic extension stentgraft system.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Pape LA, Awais M, Woznicki EM, Suzuki T, Trimarchi S, Evangelista A, Myrmel T, Larsen M, Harris KM, Greason K, Di Eusanio M, Bossone E, Montgomery DG, Eagle KA, Nienaber CA, Isselbacher EM, O'Gara P. Presentation, Diagnosis, and Outcomes of Acute Aortic Dissection: 17-Year Trends From the International Registry of Acute Aortic Dissection. J Am Coll Cardiol. 2015 Jul 28;66(4):350-8. doi: 10.1016/j.jacc.2015.05.029.
Evangelista A, Isselbacher EM, Bossone E, Gleason TG, Eusanio MD, Sechtem U, Ehrlich MP, Trimarchi S, Braverman AC, Myrmel T, Harris KM, Hutchinson S, O'Gara P, Suzuki T, Nienaber CA, Eagle KA; IRAD Investigators. Insights From the International Registry of Acute Aortic Dissection: A 20-Year Experience of Collaborative Clinical Research. Circulation. 2018 Apr 24;137(17):1846-1860. doi: 10.1161/CIRCULATIONAHA.117.031264.
First Submitted
September 5, 2025
First Posted
September 12, 2025
Study Start
September 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 30, 2027
EstimatedContact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 30, 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 15, 2025
Record last verified: 2025-09
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Source: ClinicalTrials.gov.
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