Aortic DissectionNCT05186181
Endovascular Repair With In Situ nEedle feNestration of Left Subclavian Artery to Treat AoRtic Dissection(RISEN STAR):A Multicenter Prospective Trial.
An observational study of Aortic Dissection and Left Subclavian Artery Occlusion, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
Background: Aortic dissection (AD) is a common emergency in vascular surgery, which seriously threatens human life and health. The rupture of Stanford type B dissection is located in aortic arch and the dissection range is from the descending aorta or involves the abdominal aorta. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Aortic Dissection, Left Subclavian Artery Occlusion, Vascular Diseases
- What is being tested?
- In situ fenestration
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 217 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with Stanford B-type aortic dissection, the proximal landing area is less than 15mm, and the left subclavian artery needs to be reconstructed.
Who may be able to join
- Based on Computed Tomography Angiography, it is clearly diagnosed as Stanford B type aortic dissection with a breach close to the left subclavian artery;
- The dissection the left subclavian artery, and the proximal landing area is less than 1.5cm. The proximal end of the stent needs to be anchored in zone 2 and the left subclavian needs to be performed arterial revascularization;
- Landing area requirements: no dissection, no intermural hematoma, no severe calcification, no aneurysm-like expansion, diameter 21-44mm, distance between left common carotid artery and left subclavian artery≥10mm;
- The puncture in situ fenestration technique was used to reconstruct the left subclavian artery;
- Signed informed consent;
- Age ≥18 years old, ≤85 years old, no gender limit.
Who cannot join
- Combined ascending aorta disease or performed ascending aorta surgery before;
- Congenital connective tissue disease (Marfan syndrome, etc.);
- Patients with renal failure or chronic kidney disease before endovascular repair(eGFR≤30ml/min, Dialysis needed, serum creatinine ≥2.5mg/mL within 30 days before operation);
- Cerebral hemorrhage, symptomatic cerebral infarction within 6 weeks before treatment, myocardial infarction within 6 weeks before treatment;
- Combined systemic diseases that cannot be controlled by current medical level (Such as severe heart function, lung function or liver function abnormalities, patients with advanced tumors, patients with cachexia, severe coronary heart disease symptoms that cannot be relieved, abnormal blood coagulation caused by genetic diseases, etc.) ；
- Patient under 18 years or older than 85 years;
Show all 20Show fewer
- The life expectancy of the patient is shorter than 2 years;
- Those suffering from mental illness or subjectively unable to cooperate;
- Women who are breastfeeding or pregnant, or women or men who have recently had a childbirth plan;
- Currently participating in other interventions research or patients who have been enrolled in this study;
- Have a history of aortic or left subclavian artery surgery;
- Active systemic infection or uncontrolled coagulation dysfunction within 14 days before treatment;
- Those who are unable to take the medication as required by the protocol, or are allergic to antiplatelet drugs (aspirin or clopidogrel), low molecular weight heparin or contrast agents;
- Type II heparin-induced thrombocytopenia (HIT-2) or known hypersensitivity to heparin;
- Thoracic aortic aneurysm, pseudoaneurysm, simple thoracic aortic transmural ulcer, thoracic aortic intermural hematoma;
- There are prominent or irregular thrombus and/or atheroma in the aortic arch or ascending aorta;
- The iliac artery or femoral artery approach is severely diseased and the stent cannot be passed;
- The left subclavian artery is occluded or left Those who have no suitable access for the upper extremities;
- The left subclavian artery is abnormally twisted or angled and is not suitable for fenestration;
- Other conditions that the investigator judges are not suitable for enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Donglin Li, Doctor, +8687236745, lidonglin@zju.edu.cn
Tianchi Chen, Doctor, +8687236745, tianchichen@zju.edu.cn
About this study
Official title: Endovascular Repair of Stanford B-type Thoracic Aortic Dissection With Insufficient Proximal Landing Zone by Left Subclavian Artery in Situ Stent Graft Puncture and Fenestration: A Prospective, Single-arm, Observational Clinical Trial.
Background: Aortic dissection (AD) is a common emergency in vascular surgery, which seriously threatens human life and health. The rupture of Stanford type B dissection is located in aortic arch and the dissection range is from the descending aorta or involves the abdominal aorta. At present, the endovascular repair of the thoracic aorta (TEVAR) for AD has been widely deployed worldwide and has become the standard surgical procedure for the treatment of AD. However, there is still controversy regarding the Stanford B aortic dissection that involves the left subclavian artery or the stent landing area less than 1.5 cm.
Study objective: To evaluate the effectiveness and safety of endovascular repair with in situ needle fenestration of left subclavian artery.
Methods: This study intends to enroll 217 patients with Stanford type B aortic dissection who meet the enrollment criteria. The patients will be followed up at 1, 6, 12, and 24 months after endovascular repair, and the CTA images of the thoracic aorta were collected.
- Conditions
- Aortic Dissection, Left Subclavian Artery Occlusion, Vascular Diseases, Interventional Therapy
- Being tested
- In situ fenestration
- Medical subject headings
- Aortic Dissection, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In situ fenestrationBehavioural
Interventional therapy of aortic dissection. In situ needle fenestration of left subclavian artery.
| Study group | Role | What they receive |
|---|---|---|
| group RISEN STAR | Patients with Stanford B-type aortic dissection will be treated with endovascular repair with in situ needle fenestration of left subclavian artery. Receives: Behavioral: In situ fenestration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patency rate of main and branch stent.
Patency of main and branch stent will be evaluated by Computed Tomography Angiography.
Measured: 1 month after interventional therapy.
Patency rate of main and branch stent.
Patency of main and branch stent will be evaluated by Computed Tomography Angiography.
Measured: 6 months after interventional therapy.
Patency rate of main and branch stent.
Patency of main and branch stent will be evaluated by Computed Tomography Angiography.
Measured: 12 months after interventional therapy
Patency rate of main and branch stent.
Patency of main and branch stent will be evaluated by Computed Tomography Angiography.
Measured: 24 months after interventional therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 Jan 2022
- Primary completionJan 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Aortic DissectionStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 217 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hongkun Zhang, Doctor, Study chair, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05186181
- Sponsor's protocol ID
- IIT20210205B
- Status last verified
- Feb 2023
- First submitted
- 27 Dec 2021
- Last updated
- 22 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Eggebrecht H, Mehta RH, Dechene A, Tsagakis K, Kuhl H, Huptas S, Gerken G, Jakob HG, Erbel R. Aortoesophageal fistula after thoracic aortic stent-graft placement: a rare but catastrophic complication of a novel emerging technique. JACC Cardiovasc Interv. 2009 Jun;2(6):570-6. doi: 10.1016/j.jcin.2009.03.010.
PubMed 19539264Dake MD, Kato N, Mitchell RS, Semba CP, Razavi MK, Shimono T, Hirano T, Takeda K, Yada I, Miller DC. Endovascular stent-graft placement for the treatment of acute aortic dissection. N Engl J Med. 1999 May 20;340(20):1546-52. doi: 10.1056/NEJM199905203402004.
PubMed 10332016Cambria RP, Conrad MF, Matsumoto AH, Fillinger M, Pochettino A, Carvalho S, Patel V, Matsumura J. Multicenter clinical trial of the conformable stent graft for the treatment of acute, complicated type B dissection. J Vasc Surg. 2015 Aug;62(2):271-8. doi: 10.1016/j.jvs.2015.03.026.
PubMed 26211376Canaud L, Morishita K, Gandet T, Sfeir J, Bommart S, Alric P, Mandelli M. Homemade fenestrated stent-graft for thoracic endovascular aortic repair of zone 2 aortic lesions. J Thorac Cardiovasc Surg. 2018 Feb;155(2):488-493. doi: 10.1016/j.jtcvs.2017.07.045. Epub 2017 Aug 5.
PubMed 28867380Xiang Y, Qiu C, He Y, Li D, Shang T, Wu Z, Zhang H. A Single Center Experience of In Situ Needle Fenestration of Supra-aortic Branches During Thoracic Endovascular Aortic Repair. Ann Vasc Surg. 2019 Nov;61:107-115. doi: 10.1016/j.avsg.2019.03.016. Epub 2019 Jun 11.
PubMed 31200061
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endovascular Repair of Stanford B-type Thoracic Aortic Dissection With Insufficient Proximal Landing Zone by Left Subclavian Artery in Situ Stent Graft Puncture and Fenestration: A Prospective, Single-arm, Observational Clinical Trial.
- ClinicalTrials.gov ID
- NCT05186181
- Acronym / sponsor ID
- IIT20210205B
- Conditions
- Aortic Dissection, Left Subclavian Artery Occlusion, Vascular Diseases, Interventional Therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 217 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 11 Jan 2022 (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.
Background: Aortic dissection (AD) is a common emergency in vascular surgery, which seriously threatens human life and health. The rupture of Stanford type B dissection is located in aortic arch and the dissection range is from the descending aorta or involves the abdominal aorta. At present, the endovascular repair of the thoracic aorta (TEVAR) for AD has been widely deployed worldwide and has become the standard surgical procedure for the treatment of AD. However, there is still controversy regarding the Stanford B aortic dissection that involves the left subclavian artery or the stent landing area less than 1.5 cm.
Study objective: To evaluate the effectiveness and safety of endovascular repair with in situ needle fenestration of left subclavian artery.
Methods: This study intends to enroll 217 patients with Stanford type B aortic dissection who meet the enrollment criteria. The patients will be followed up at 1, 6, 12, and 24 months after endovascular repair, and the CTA images of the thoracic aorta were collected.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| group RISEN STAR | – | Behavioral: In situ fenestrationPatients with Stanford B-type aortic dissection will be treated with endovascular repair with in situ needle fenestration of left subclavian artery. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with Stanford B-type aortic dissection, the proximal landing area is less than 15mm, and the left subclavian artery needs to be reconstructed.
Key inclusion criteria (6 listed)
- Based on Computed Tomography Angiography, it is clearly diagnosed as Stanford B type aortic dissection with a breach close to the left subclavian artery;
- The dissection the left subclavian artery, and the proximal landing area is less than 1.5cm. The proximal end of the stent needs to be anchored in zone 2 and the left subclavian needs to be performed arterial revascularization;
- Landing area requirements: no dissection, no intermural hematoma, no severe calcification, no aneurysm-like expansion, diameter 21-44mm, distance between left common carotid artery and left subclavian artery≥10mm;
- The puncture in situ fenestration technique was used to reconstruct the left subclavian artery;
- Signed informed consent;
Key exclusion criteria (20 listed)
- Combined ascending aorta disease or performed ascending aorta surgery before;
- Congenital connective tissue disease (Marfan syndrome, etc.);
- Patients with renal failure or chronic kidney disease before endovascular repair(eGFR≤30ml/min, Dialysis needed, serum creatinine ≥2.5mg/mL within 30 days before operation);
- Cerebral hemorrhage, symptomatic cerebral infarction within 6 weeks before treatment, myocardial infarction within 6 weeks before treatment;
- Combined systemic diseases that cannot be controlled by current medical level (Such as severe heart function, lung function or liver function abnormalities, patients with advanced tumors, patients with cachexia, severe coronary heart disease symptoms that cannot be relieved, abnormal blood coagulation caused by genetic diseases, etc.) ；
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 |
|---|---|---|
| In situ fenestrationInterventional therapy of aortic dissection. In situ needle fenestration of left subclavian artery. | Behavioural | group RISEN STAR |
Primary outcome
Patency rate of main and branch stent.
Time frame: 1 month after interventional therapy.
Patency of main and branch stent will be evaluated by Computed Tomography Angiography.
Patency rate of main and branch stent.
Time frame: 6 months after interventional therapy.
Patency of main and branch stent will be evaluated by Computed Tomography Angiography.
Patency rate of main and branch stent.
Time frame: 12 months after interventional therapy
Patency of main and branch stent will be evaluated by Computed Tomography Angiography.
Patency rate of main and branch stent.
Time frame: 24 months after interventional therapy
Patency of main and branch stent will be evaluated by Computed Tomography Angiography.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
- Background: PubMed 19539264Eggebrecht H, Mehta RH, Dechene A, Tsagakis K, Kuhl H, Huptas S, Gerken G, Jakob HG, Erbel R. Aortoesophageal fistula after thoracic aortic stent-graft placement: a rare but catastrophic complication of a novel emerging technique. JACC Cardiovasc Interv. 2009 Jun;2(6):570-6. doi: 10.1016/j.jcin.2009.03.010.
- Results publication: PubMed 10332016Dake MD, Kato N, Mitchell RS, Semba CP, Razavi MK, Shimono T, Hirano T, Takeda K, Yada I, Miller DC. Endovascular stent-graft placement for the treatment of acute aortic dissection. N Engl J Med. 1999 May 20;340(20):1546-52. doi: 10.1056/NEJM199905203402004.
- Results publication: PubMed 26211376Cambria RP, Conrad MF, Matsumoto AH, Fillinger M, Pochettino A, Carvalho S, Patel V, Matsumura J. Multicenter clinical trial of the conformable stent graft for the treatment of acute, complicated type B dissection. J Vasc Surg. 2015 Aug;62(2):271-8. doi: 10.1016/j.jvs.2015.03.026.
- Results publication: PubMed 28867380Canaud L, Morishita K, Gandet T, Sfeir J, Bommart S, Alric P, Mandelli M. Homemade fenestrated stent-graft for thoracic endovascular aortic repair of zone 2 aortic lesions. J Thorac Cardiovasc Surg. 2018 Feb;155(2):488-493. doi: 10.1016/j.jtcvs.2017.07.045. Epub 2017 Aug 5.
- Results publication: PubMed 31200061Xiang Y, Qiu C, He Y, Li D, Shang T, Wu Z, Zhang H. A Single Center Experience of In Situ Needle Fenestration of Supra-aortic Branches During Thoracic Endovascular Aortic Repair. Ann Vasc Surg. 2019 Nov;61:107-115. doi: 10.1016/j.avsg.2019.03.016. Epub 2019 Jun 11.
- 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. This study is not recruiting at the moment.
Hongkun Zhang, Doctor study chair
Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Dissection and Left Subclavian Artery Occlusion, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
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 20 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: status not confirmed, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongkun Zhang, Doctor (+8687236745, 1198050@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patency rate of main and branch stent. (time frame: 1 month after interventional therapy.). The study lists 4 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 NCT05186181, which also lists 5 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 22 Feb 2023.