Distal Aortic DissectionNCT01914237
A Multi-center Trial of Single-Branched Stent Graft System to Treat Aortic Dissection
A study testing Castor Stent Graft in people with Distal Aortic Dissection, run by Changhai Hospital at 1 site in China.
Trial summary
Aim:Castor is a novel single-branched stent graft system for endovascular repair of aortic arch dissection. This is a prospective, one-arm, open, multi-center, pre-market study of Castor stent to evaluate its efficacy and safety in treatment of aortic dissection. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Distal Aortic Dissection
- What is being tested?
- Castor Stent Graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- Apr 2013to Apr 2017
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age from 18 to 80, male or unpregnant female
- diagnosed as aortic dissection
- proximal tear of the dissection locates between 15mm to the distal end of left common carotid artery and 20mm to the distal end of left subclavian artery (LSA) or inverse tear to LSA
- good compliance with the instructions and cooperate with follow-up
- voluntarily signed the informed consent form
Who cannot join
- Pregnant female
- no appropriate vessel approaches
- patients with connective tissue diseases (such as Marfan syndrome)
- allergic to nitinol or contrast medium
- bad compliance with the instructions and follow-up
- estimated remaining life is less than 12 months
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Vascular Surgery, Changhai Hospital
Shanghai, Shanghai Municipality, 200433
Zaiping JING, MD, 86-21-31166666, jingzp@xueguan.net
About this study
Official title: A Multi-center Trial of Castor Single-Branched Stent Graft System for Endovascular Repair of Aortic Dissection.
Aim:Castor is a novel single-branched stent graft system for endovascular repair of aortic arch dissection. This is a prospective, one-arm, open, multi-center, pre-market study of Castor stent to evaluate its efficacy and safety in treatment of aortic dissection.
Number of patients: 70 patients will be included and undertaken endovascular repair with Castor stent.
Read more
Follow-up: 1.aortic computed tomographic angiography (CTA) examination 6 and 12 months after the surgery 2.telephone or clinical follow-up 30 days and 2-5 years after the surgery
Primary Outcome Measure: success rate of endovascular repair for efficacy measurement.
Secondary Outcome Measure: 1 year stent related adverse event rate for safety measurement.
Other Outcome Measures:
- efficacy:
- 1 year success rate of treatment
- 1 year patency rate of branch stent
- safety:
- in-hospital mortality
- complication rate of neural system
- 1 year dissection or stent related mortality
- Conditions
- Distal Aortic Dissection
- Being tested
- Castor Stent Graft
- Keywords
- Single-Branched Stent Graft System, Aortic Dissection, Endovascular Repair
- Medical subject headings
- Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Castor Stent GraftDevice
Also called Castor Single-Branched Stent Graft System
Endovascular Repair of Aortic Dissection
| Study group | Role | What they receive |
|---|---|---|
| Castor Stent Graft | Experimental | To study the safety and efficacy of Castor single-branched stent graft system in endovascular repair of aortic dissection. Receives: Device: Castor Stent Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate of endovascular repair
- during the surgery: successful conduction, accurate positioning and release, and no warping, folding, narrowing or blocking of the stent graft system. Immediately after the stent release, angiography shows both main stent and side arm stent patency, successful exclusion of dissection and no arteriorrhexis or dissection rupture.
Measured: during the surgery
Secondary outcomes (1)
1 year stent related adverse event rate
- unexpected breakage and shifting of the stent
- type I or type III endoleak which needs intervention
- dissection rupture around the stent
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2015 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Aortic DissectionStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fudan University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Central South University, Beijing Anzhen Hospital, Peking Union Medical College Hospital, Peking University People's Hospital, Chinese PLA General Hospital, The Second Affiliated Hospital of Harbin Medical University, The First Affiliated Hospital with Nanjing Medical University, Nanjing PLA General Hospital, First Affiliated Hospital, Sun Yat-Sen University, Shandong Provincial Hospital, The First Affiliated Hospital of Zhengzhou University, Xijing Hospital, China Medical University, China, First Affiliated Hospital of Chongqing Medical University
- Responsible party
- Principal investigator, Zaiping JING, Changhai Hospital
- Investigators
- Zaiping JING, MD, Principal investigator, Department of Vascular Surgery, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01914237
- Sponsor's protocol ID
- Castor-2012-04
- Status last verified
- Aug 2013
- First submitted
- 30 Jul 2013
- Last updated
- 2 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Trial of Castor Single-Branched Stent Graft System for Endovascular Repair of Aortic Dissection.
- ClinicalTrials.gov ID
- NCT01914237
- Acronym / sponsor ID
- Castor-2012-04
- Conditions
- Distal Aortic Dissection
- Keywords
- Single-Branched Stent Graft System, Aortic Dissection, Endovascular Repair
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- Fudan University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Central South University, Beijing Anzhen Hospital, Peking Union Medical College Hospital, Peking University People's Hospital, Chinese PLA General Hospital, The Second Affiliated Hospital of Harbin Medical University, The First Affiliated Hospital with Nanjing Medical University, Nanjing PLA General Hospital, First Affiliated Hospital, Sun Yat-Sen University, Shandong Provincial Hospital, The First Affiliated Hospital of Zhengzhou University, Xijing Hospital, China Medical University, China, First Affiliated Hospital of Chongqing Medical University
- Study start
- Apr 2013
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 2 Aug 2013 (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.
Aim:Castor is a novel single-branched stent graft system for endovascular repair of aortic arch dissection. This is a prospective, one-arm, open, multi-center, pre-market study of Castor stent to evaluate its efficacy and safety in treatment of aortic dissection.
Number of patients: 70 patients will be included and undertaken endovascular repair with Castor stent.
Follow-up: 1.aortic computed tomographic angiography (CTA) examination 6 and 12 months after the surgery 2.telephone or clinical follow-up 30 days and 2-5 years after the surgery
Primary Outcome Measure: success rate of endovascular repair for efficacy measurement.
Secondary Outcome Measure: 1 year stent related adverse event rate for safety measurement.
Other Outcome Measures:
- efficacy:
- 1 year success rate of treatment
- 1 year patency rate of branch stent
- safety:
- in-hospital mortality
- complication rate of neural system
- 1 year dissection or stent related mortality
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Castor Stent Graft | Experimental | Device: Castor Stent GraftTo study the safety and efficacy of Castor single-branched stent graft system in endovascular repair of aortic dissection. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age from 18 to 80, male or unpregnant female
- diagnosed as aortic dissection
- proximal tear of the dissection locates between 15mm to the distal end of left common carotid artery and 20mm to the distal end of left subclavian artery (LSA) or inverse tear to LSA
- good compliance with the instructions and cooperate with follow-up
- voluntarily signed the informed consent form
Key exclusion criteria (6 listed)
- Pregnant female
- no appropriate vessel approaches
- patients with connective tissue diseases (such as Marfan syndrome)
- allergic to nitinol or contrast medium
- bad compliance with the instructions and follow-up
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 |
|---|---|---|
| Castor Stent GraftAlso: Castor Single-Branched Stent Graft SystemEndovascular Repair of Aortic Dissection | Device | Castor Stent Graft |
Primary outcome
success rate of endovascular repair
Time frame: during the surgery
- during the surgery: successful conduction, accurate positioning and release, and no warping, folding, narrowing or blocking of the stent graft system. Immediately after the stent release, angiography shows both main stent and side arm stent patency, successful exclusion of dissection and no arteriorrhexis or dissection rupture.
1 secondary outcome
1 year stent related adverse event rate
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2013.
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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.
Zaiping JING, MD principal investigator
Department of Vascular Surgery, Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Castor Stent Graft in people with Distal Aortic Dissection, run by Changhai 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 5 inclusion and 6 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 2 Aug 2013. 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 Zaiping JING, MD (86-21-31166666, jingzp@xueguan.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
success rate of endovascular repair (time frame: during the surgery). 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 2 Aug 2013.