ZIPPER™ Stent-Graft Trial for Aortic Arch Dissection

Official title

Clinical Study on the Safety and Efficacy of the ZIPPER™ Aortic Arch Stent-Graft System in the Treatment of Aortic Arch Dissection

Overview

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 efficacy of ZIPPER aortic arch stentgraft system in the treatment of patients with aortic arch dissections, residual dissection following ascending aorta surgical operation.

Interventions

• Device ZIPPER™ Stent-Graft Trial for Aortic Arch Dissection
  The ZIPPER aortic arch stentgraft system consists of the arch mainbody stentgraft system, the branch artery stentgraft system and the thoracic extension stentgraft system.

Primary outcome measures

• 30-day major adverse event (MAE)-free rate [Time frame: 30 days after intervention]
• 12-month Clinical Treatment Success Rate [Time frame: 12 months post-intervention]

Secondary outcome measures (10)

• All-cause mortality rate [Time frame: 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) [Time frame: Prior to discharge, 30 days, 6 months,12 months, 24-60 months post-procedure]
• Aortic dissection-related mortality rate [Time frame: Prior to discharge, 30 days, 6 months,12 months, 24-60 months post-procedure]
• Major adverse event (MAE) rate [Time frame: Prior to discharge, 30 days, 6 months,12 months, 24-60 months post-procedure]
• Device-related adverse event rate [Time frame: Prior to discharge, 30 days, 6 months,12 months, 24-60 months post-procedure]
• Aortic dissection vascular remodeling success rate. Evaluation: Assessed via CT angiography (CTA), defined as: True lumen expansion in the stented aortic segment; False lumen reduction or obliteration; False lumen thrombosis formation. [Time frame: Prior to discharge, 30 days, 6 months,12 months, 24-60 months post-procedure]
• Type I or III endoleak incidence rate [Time frame: Prior to discharge, 30 days, 6 months,12 months, 24-60 months post-procedure]
• Aortic and branch stent graft migration rate [Time frame: Prior to discharge, 30 days, 6 months,12 months, 24-60 months post-procedure]
• Postoperative branch vessel occlusion rate [Time frame: Prior to discharge, 30 days, 6 months,12 months, 24-60 months post-procedure]
• Secondary surgical intervention rate [Time frame: Prior to discharge, 30 days, 6 months,12 months, 24-60 months post-procedure]

Eligibility criteria

Inclusion criteria

• 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 criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• 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. PMID 26205591
• 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/CIR PMID 29685932

Identifiers

NCT: NCT07170332 · WQ202501

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗