New stent aims to fix deadly aortic tear without open surgery
NCT ID NCT07170332
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tests a new device called the ZIPPER stent-graft system for treating aortic arch dissection, a life-threatening tear in the main artery. About 127 people with subacute or chronic dissection will receive the device. Researchers will check for major complications within 30 days and success at 12 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ZIPPER aortic arch stent-graft system (a device placed inside the aorta to repair a tear)
- What this could lead to
- If successful, this could provide a less invasive treatment option for people with a dangerous tear in the main artery from the heart.
- What could go wrong
- This is an early feasibility study, not a large final trial. The device may cause serious complications like stroke, kidney failure, or death.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 127 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2025
An estimate. Start dates often move.
- Expected to finish
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Sep 2032
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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): 1. Unruptured aneurysm ≥7 mm (anterior circulation) or ≥5 mm (posterior circulation) 2. Prior rupture or high-risk morphology (daughter sac, aspect ratio \>1.6) 3. 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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.