ZIPPER™ Stent-Graft Trial for Aortic Arch Dissection

NCT07170332 | Not Yet Recruiting

• 1 other identifier: WQ202501
• Study Type: interventional
• Target: 127
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is the feasible study on a new technique of ZIPPER aortic arch stentgraft system

Conditions

Dissection of Aortic Arch

Keywords

Aortic Arch; Dissection

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (10)

• 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

Study Arms (1)

Experimental

EXPERIMENTAL

The ZIPPER aortic arch stentgraft system consists of the arch mainbody stentgraft system, the branch artery stentgraft system and the thoracic extension stentgraft system.

Device: ZIPPER™ Stent-Graft Trial for Aortic Arch Dissection

Interventions

ZIPPER™ Stent-Graft Trial for Aortic Arch Dissection DEVICE

The ZIPPER aortic arch stentgraft system consists of the arch mainbody stentgraft system, the branch artery stentgraft system and the thoracic extension stentgraft system.

Experimental

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-80 years of age.
• Diagnosis and Anatomical Suitability:
• Subacute or chronic aortic arch dissection requiring intervention, where the proximal end of the stent graft requires anchoring in Zone 0, and meets the following vascular anatomical criteria:
• Ascending aorta (may include graft segments) ≥ 40 mm in length (measured from the sinotubular junction to the proximal edge of the IA along the centerline).
• Proximal landing zone diameter ≥ 24 mm and ≤ 47 mm. Proximal landing zone length ≥ 20 mm. Diameters of the IA, LCCA, and LSA ≤ 24 mm and ≥ 6 mm, with lengths ≥ 20 mm. Suitable arterial access for endovascular intervention. Informed Consent: Capable of understanding the study purpose, voluntarily agreeing to participate, and providing written informed consent (by the subject or their legal representative). Willing to comply with follow-up requirements per the protocol.
• Surgical Risk Assessment: Deemed high surgical risk (evaluated by at least two independent vascular or cardiac surgeons) or confirmed to have significant contraindications to open surgery.

You may not qualify if:

• Prior aortic intervention: History of open or endovascular repair of the descending or abdominal aorta.
• Concurrent AAA requiring intervention: Coexisting abdominal aortic aneurysm requiring surgical intervention within 30 days.
• Specific aortic pathologies: infectious aortitis, Takayasu arteritis, Marfan syndrome, or other connective tissue disorders.
• Active systemic infection: Ongoing systemic infection or high risk of systemic infection.
• Severe arch vessel disease: Severe stenosis, calcification, thrombosis, or tortuosity of the IA, LCCA, or LSA.
• Acute ischemia: Bowel necrosis or lower limb ischemic necrosis. Pre-existing paraplegia. Post-cardiac transplant status. Recent cardiovascular events: Myocardial infarction or stroke within the past 3 months.
• Advanced heart failure: NYHA Class IV or left ventricular ejection fraction (LVEF) \<30%.
• Active gastrointestinal bleeding: Active peptic ulcer or upper gastrointestinal bleeding within the past 3 months.
• Hematologic abnormalities: Leukopenia (WBC \< 3×10⁹/L), Anemia (Hb \< 90 g/L), Coagulopathy, Thrombocytopenia (platelets \< 50×10⁹/L).
• Renal insufficiency: Serum creatinine \> 221 μmol/L (2.5 mg/dL) or end-stage renal disease requiring dialysis (investigator discretion).
• Severe hepatic dysfunction: ALT/AST \> 5× upper limit of normal (ULN), Serum total bilirubin (STB) \> 2× ULN.
• High-risk intracranial lesions (any of the following):
• Unruptured aneurysm ≥7 mm (anterior circulation) or ≥5 mm (posterior circulation)
• Prior rupture or high-risk morphology (daughter sac, aspect ratio \>1.6)
• Intracranial arterial stenosis ≥50% with poor collateral flow. Contrast allergy. Pregnancy or lactation. Anesthesia/surgery contraindications: Severe comorbidities precluding tolerance to anesthesia or surgery.

Sponsors & Collaborators

• Hangzhou Endonom Medtech Co., Ltd.: lead

Related Publications (2)

• 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.

  PMID: 26205591 BACKGROUND

• 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.

  PMID: 29685932 BACKGROUND

Central Study Contacts

Zhang Wayne W, Medical Doctorate

CONTACT

+8615895901908; wwzhang08@gmail.com

Fu Weiguo, Medical Doctorate

CONTACT

+8613801760929; fu.weiguo@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 12, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2032
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share