Status:
NOT_YET_RECRUITING
ZIPPER™ Stent-Graft Trial for Aortic Arch Dissection
Lead Sponsor:
Hangzhou Endonom Medtech Co., Ltd.
Conditions:
Dissection of Aortic Arch
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This study is the feasible study on a new technique of ZIPPER aortic arch stentgraft system
Detailed Description
The study of ZIPPER aortic arch stentgraft system is a prospective, multicenter, single arm trial, which will enroll a total of 127 patients. The goal of this study is to evaluate the safety and effic...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Life expectancy \< 12 months. Current participation in other drug or device clinical trials. Other exclusions: Any conditions deemed unsuitable for participation by the investigator.
Key Trial Info
Start Date :
September 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2032
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT07170332
Start Date
September 30 2025
End Date
September 30 2032
Last Update
September 15 2025
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