ZIPPER™ Stent-Graft Trial for Aortic Arch Dissection
ConditionDissection of Aortic Arch
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHangzhou Endonom Medtech Co., Ltd.
About this trial
This study is the feasible study on a new technique of ZIPPER aortic arch stentgraft system
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: 18-80 years of age.
Disqualifiers
Prior aortic intervention: History of open or endovascular repair of the descending or abdominal aorta.
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.
Trial design
Design model
Single group
Treatments tested in this trial
ZIPPER™ Stent-Graft Trial for Aortic Arch Dissection
DeviceThe ZIPPER aortic arch stentgraft system consists of the arch mainbody stentgraft system, the branch artery stentgraft system and the thoracic extension stentgraft system.
Treatment groups
127 Participants
are divided into 1 treatment groupGroup A: ExperimentalExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
30 days after intervention2
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
Time frame
12 months post-interventionSecondary outcomes
1
All-cause mortality rate
Time frame
Prior to discharge, 30 days, 6 months,12 months, 24-60 months post-procedure2
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-procedure3
Aortic dissection-related mortality rate
Time frame
Prior to discharge, 30 days, 6 months,12 months, 24-60 months post-procedure4
Major adverse event (MAE) rate
Time frame
Prior to discharge, 30 days, 6 months,12 months, 24-60 months post-procedureLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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