Aorta DissectionNCT01496833
Total Endovascular Aortic Arch Re-construction Study(TEARS)
A study testing Ankura Branched/Fenestrated Stent Graft in people with Aorta Dissection and Aorta Aneurysm, run by Xijing Hospital at 1 site in China.
Trial summary
The purpose of this study is to investigate the short to mid term efficacy and safety of a newly-developed branched stent graft in patients who had complex aortic lesions, such as ascending aortic/arch aneurysm, pseudo-aneurysm, Stanford Type A dissection, retrograde Stanford Type B dissection, dissection with primary… Read more about this study
- Who is it for?
- Ages 12 to 90 years
- Conditions the study is for
- Aorta Dissection, Aorta Aneurysm
- What is being tested?
- Ankura Branched/Fenestrated Stent Graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Dec 2018
- Phase
- Interventional
- 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 12 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Ascending aortic/arch aneurysm
- Ascending aortic/arch pseudo-aneurysm
- Stanford Type A dissection
- Retrograde Stanford Type B dissection
- Unclassified dissection with primary tear located in the aortic arch
- Able to tolerate endotracheal intubation and general anesthesia
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- Subject's anatomy must meet the anatomical criteria to receive that implanted device
- The subject or legal guardian understands the nature of the study and agrees to its provisions on a written informed consent form
- Availability for the appropriate follow-up visits during the follow-up period
- Capability to follow all study requirements
Who cannot join
- ASA classification = V
- Severe renal insufficiency defined as SVS risk renal status = 3
- Severe respiratory insufficiency defined as SVS risk pulmonary status = 3
- Presence of connective tissue disease
- Active infection or active vasculitides
- Pregnant woman or positive pregnancy test
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- Myocardial infarction or cerebrovascular accident within 6 weeks prior to study enrollment
- Subject has had a cerebral vascular accident (CVA) within 2 months.
- History of drug abuse
- Subject has a history of bleeding diathesis, coagulopathy, or refuses blood transfusion.
- Subject has a known allergy or intolerance to the device components.
- Subject has a known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.
- Subject has a co-morbidity causing expected survival to be less than 1 year.
- Enrolment in another clinical study
- Unwillingness to cooperate with study procedures or follow-up visits
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, 710032
Jian Yang, MD,PhD
About this study
Official title: Total Endovascular Aortic Arch Re-construction Study(TEARS)------China's Registry
The purpose of this study is to investigate the short to mid term efficacy and safety of a newly-developed branched stent graft in patients who had complex aortic lesions, such as ascending aortic/arch aneurysm, pseudo-aneurysm, Stanford Type A dissection, retrograde Stanford Type B dissection, dissection with primary tear located in the aortic arch, et al.
Read the detailed description
Aneurysms and dissection involving the ascending aorta and aortic arch have historically been treated with open surgical techniques, requiring cardiopulmonary bypass and deep hypothermic circulatory arrest (DHCA). Despite increasing experience and refinement of these procedures, there remains a substantial rate of morality and morbidity. Total endovascular aortic arch and ascending aorta repair is one of the ultimate solutions of these diseases. However, this approach requires extensive technique and new device development. The goal of total endoluminal stent grafting is to re-construct the ascending aorta and aortic arch to cover the primary entry tear of the dissection and to remodel the aorta.Recently, branch and fenestrated stent-grafts has been developed to treat complex ascending and aortic arch disease, which was previously considered to be contraindicated for endovascular repair. This study aims to investigate the short to mid term efficacy and safety of a newly-developed branched stent graft in patients who had complex aortic lesions, such as ascending aortic/arch aneurysm, pseudo-aneurysm, Stanford Type A dissection, retrograde Stanford Type B dissection, dissection with primary tear located in the aortic arch, et al.
Primary outcome measure is all-cause mortality. Secondary outcome variables include conversion to stent and/or surgery, induced thrombosis of the false lumen, cardiovascular morbidity, aortic expansion (>5 mm/y of maximum diameter including true and false lumina), quality of life, and length of intensive care unit and hospital stay. The study designs to enroll 50 patients to be monitored for 24 months.
- Conditions
- Aorta Dissection, Aorta Aneurysm
- Being tested
- Ankura Branched/Fenestrated Stent Graft
- Keywords
- Aortic Diseases, Vascular Diseases, Cardiovascular Diseases, Treatment Outcome, Aorta Dissection, Aorta Aneurysm, Aorta pseudoaneurysm, Endovascular aortic repair
- Medical subject headings
- Aortic Dissection, Aortic Aneurysm, Aortic Diseases, Vascular Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankura Branched/Fenestrated Stent GraftDevice
Also called Ankura-TM Stent Graft, Ankura Branched Stent Graft, Ankura Fenestrated Stent Graft
Ankura Branched/Fenestrated Stent Graft（Lifetech Scientific Co.,LTD.，Shenzhen, China）
| Study group | Role | What they receive |
|---|---|---|
| Endovascular | Experimental | Total endovascular arch reconstruction Receives: Device: Ankura Branched/Fenestrated Stent Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
cumulative MACE (including death, rupture, paraplegia, aneurysm formation)
Measured: 12 months
Secondary outcomes (3)
Endoleak
Endoleak of all types
Measured: 12 months
Stent-graft migration/kinking
Stent-graft migration, stenosis, kinking and other conditions requiring re-intervention
Measured: 12 months
cumulative cerebrovascular events
cumulative cerebrovascular events
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2011 (estimated)
- Study startJan 2015
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aorta DissectionStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jian Yang, MD,PhD, Principal investigator, Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical UniversityDinghua Yi, M.D., PhD., Study chair, Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01496833
- Sponsor's protocol ID
- XJ-20111126
- Status last verified
- Dec 2015
- First submitted
- 13 Dec 2011
- Last updated
- 1 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Endovascular Aortic Arch Re-construction Study(TEARS)------China's Registry
- ClinicalTrials.gov ID
- NCT01496833
- Acronym / sponsor ID
- XJ-20111126
- Conditions
- Aorta Dissection, Aorta Aneurysm
- Keywords
- Aortic Diseases, Vascular Diseases, Cardiovascular Diseases, Treatment Outcome, Aorta Dissection, Aorta Aneurysm, Aorta pseudoaneurysm, Endovascular aortic repair
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 21 Dec 2011 (estimated)
- 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.
The purpose of this study is to investigate the short to mid term efficacy and safety of a newly-developed branched stent graft in patients who had complex aortic lesions, such as ascending aortic/arch aneurysm, pseudo-aneurysm, Stanford Type A dissection, retrograde Stanford Type B dissection, dissection with primary tear located in the aortic arch, et al.
Detailed description
Aneurysms and dissection involving the ascending aorta and aortic arch have historically been treated with open surgical techniques, requiring cardiopulmonary bypass and deep hypothermic circulatory arrest (DHCA). Despite increasing experience and refinement of these procedures, there remains a substantial rate of morality and morbidity. Total endovascular aortic arch and ascending aorta repair is one of the ultimate solutions of these diseases. However, this approach requires extensive technique and new device development. The goal of total endoluminal stent grafting is to re-construct the ascending aorta and aortic arch to cover the primary entry tear of the dissection and to remodel the aorta.Recently, branch and fenestrated stent-grafts has been developed to treat complex ascending and aortic arch disease, which was previously considered to be contraindicated for endovascular repair. This study aims to investigate the short to mid term efficacy and safety of a newly-developed branched stent graft in patients who had complex aortic lesions, such as ascending aortic/arch aneurysm, pseudo-aneurysm, Stanford Type A dissection, retrograde Stanford Type B dissection, dissection with primary tear located in the aortic arch, et al.
Primary outcome measure is all-cause mortality. Secondary outcome variables include conversion to stent and/or surgery, induced thrombosis of the false lumen, cardiovascular morbidity, aortic expansion (>5 mm/y of maximum diameter including true and false lumina), quality of life, and length of intensive care unit and hospital stay. The study designs to enroll 50 patients to be monitored for 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endovascular | Experimental | Device: Ankura Branched/Fenestrated Stent GraftTotal endovascular arch reconstruction |
Who may qualify
- Ages
- 12 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Ascending aortic/arch aneurysm
- Ascending aortic/arch pseudo-aneurysm
- Stanford Type A dissection
- Retrograde Stanford Type B dissection
- Unclassified dissection with primary tear located in the aortic arch
Key exclusion criteria (15 listed)
- ASA classification = V
- Severe renal insufficiency defined as SVS risk renal status = 3
- Severe respiratory insufficiency defined as SVS risk pulmonary status = 3
- Presence of connective tissue disease
- Active infection or active vasculitides
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 |
|---|---|---|
| Ankura Branched/Fenestrated Stent GraftAlso: Ankura-TM Stent Graft, Ankura Branched Stent Graft, Ankura Fenestrated Stent GraftAnkura Branched/Fenestrated Stent Graft（Lifetech Scientific Co.,LTD.，Shenzhen, China） | Device | Endovascular |
Primary outcome
cumulative MACE (including death, rupture, paraplegia, aneurysm formation)
Time frame: 12 months
3 secondary outcomes
Endoleak
Time frame: 12 months
Stent-graft migration/kinking
Time frame: 12 months
cumulative cerebrovascular events
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2016.
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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.
Jian Yang, MD,PhD principal investigator
Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University
Dinghua Yi, M.D., PhD. study chair
Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ankura Branched/Fenestrated Stent Graft in people with Aorta Dissection and Aorta Aneurysm, run by Xijing Hospital 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 10 inclusion and 15 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 1 Jan 2016. 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 Jian Yang, MD,PhD (86-13892828016, yangjian1212@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cumulative MACE (including death, rupture, paraplegia, aneurysm formation) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jan 2016.