Dissection of Aortic ArchNCT07170332
ZIPPER™ Stent-Graft Trial for Aortic Arch Dissection
A study testing ZIPPER™ Stent-Graft Trial for Aortic Arch Dissection in people with Dissection of Aortic Arch, run by Hangzhou Endonom Medtech Co., Ltd..
Trial summary
This study is the feasible study on a new technique of ZIPPER aortic arch stentgraft system Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dissection of Aortic Arch
- What is being tested?
- ZIPPER™ Stent-Graft Trial for Aortic Arch Dissection
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2025to 30 Sep 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Study on the Safety and Efficacy of the ZIPPER™ Aortic Arch Stent-Graft System in the Treatment of Aortic Arch Dissection
This study is the feasible study on a new technique of ZIPPER aortic arch stentgraft system
Read the 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.
- Conditions
- Dissection of Aortic Arch
- Being tested
- ZIPPER™ Stent-Graft Trial for Aortic Arch Dissection
- Keywords
- Aortic Arch, Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZIPPER™ Stent-Graft Trial for Aortic Arch DissectionDevice
The ZIPPER aortic arch stentgraft system consists of the arch mainbody stentgraft system, the branch artery stentgraft system and the thoracic extension stentgraft system.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: ZIPPER™ Stent-Graft Trial for Aortic Arch Dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 12 months post-intervention
Secondary outcomes (10)
All-cause mortality rate
Measured: 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)
Measured: Prior to discharge, 30 days, 6 months,12 months, 24-60 months post-procedure
Aortic dissection-related mortality rate
Measured: Prior to discharge, 30 days, 6 months,12 months, 24-60 months post-procedure
Major adverse event (MAE) rate
Measured: Prior to discharge, 30 days, 6 months,12 months, 24-60 months post-procedure
Device-related adverse event rate
Measured: 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.
Measured: Prior to discharge, 30 days, 6 months,12 months, 24-60 months post-procedure
Type I or III endoleak incidence rate
Measured: Prior to discharge, 30 days, 6 months,12 months, 24-60 months post-procedure
Aortic and branch stent graft migration rate
Measured: Prior to discharge, 30 days, 6 months,12 months, 24-60 months post-procedure
Postoperative branch vessel occlusion rate
Measured: Prior to discharge, 30 days, 6 months,12 months, 24-60 months post-procedure
Secondary surgical intervention rate
Measured: Prior to discharge, 30 days, 6 months,12 months, 24-60 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start30 Sep 2025 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dissection of Aortic ArchStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 127 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou Endonom Medtech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07170332
- Sponsor's protocol ID
- WQ202501
- Status last verified
- Sep 2025
- First submitted
- 5 Sep 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.jacc.2015.05.029.
PubMed 26205591Evangelista 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.
PubMed 29685932
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Safety and Efficacy of the ZIPPER™ Aortic Arch Stent-Graft System in the Treatment of Aortic Arch Dissection
- ClinicalTrials.gov ID
- NCT07170332
- Acronym / sponsor ID
- WQ202501
- Conditions
- Dissection of Aortic Arch
- Keywords
- Aortic Arch, Dissection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 127 participants (estimated)
- Lead sponsor
- Hangzhou Endonom Medtech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2025 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2032 (estimated)
- First posted
- 12 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: ZIPPER™ Stent-Graft Trial for Aortic Arch DissectionThe ZIPPER aortic arch stentgraft system consists of the arch mainbody stentgraft system, the branch artery stentgraft system and the thoracic extension stentgraft system. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: 18-80 years of age.
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZIPPER™ Stent-Graft Trial for Aortic Arch DissectionThe ZIPPER aortic arch stentgraft system consists of the arch mainbody stentgraft system, the branch artery stentgraft system and the thoracic extension stentgraft system. | Device | Experimental |
Primary outcome
30-day major adverse event (MAE)-free rate
Time frame: 30 days after intervention
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
12-month Clinical Treatment Success Rate
Time frame: 12 months post-intervention
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
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Results publication: PubMed 26205591Pape 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.
- Results publication: PubMed 29685932Evangelista 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing ZIPPER™ Stent-Graft Trial for Aortic Arch Dissection in people with Dissection of Aortic Arch, run by Hangzhou Endonom Medtech Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhang Wayne W, Medical Doctorate (+8615895901908, wwzhang08@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day major adverse event (MAE)-free rate (time frame: 30 days after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07170332, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.