Aortic Dissection Type BNCT02726841
Hybrid Treatment of Type B Aortic Dissection
A study testing Open thoracoabdominal aortic repair + abdominal stenting and Classic thoracoabdominal aortic repair in people with Aortic Dissection Type B, run by Meshalkin Research Institute of Pathology of Circulation.
Trial summary
Authors hypothesize that thoracoabdominal aortic repair combined with bare metal stent implantation is superior over standard thoracoabdominal aortic repair. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Aortic Dissection Type B
- What is being tested?
- Open thoracoabdominal aortic repair + abdominal stenting and Classic thoracoabdominal aortic repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Jan 2020
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic aortic dissection type B
- Aortic size in descending thoracoabdominal aorta (TAA) > 55 mm
Who cannot join
- concomitant cardiac pathology
- concomitant oncology diseases in the last 5 years
- acute aortic dissection
- aortic size in visceral zone >45 mm
- connectivity tissue diseases
About this study
Official title: Superiority Trial of Type b Aortic Dissection Treatment Combined With Implantation of Bare Metal Stent in Abdominal Part of Aorta Versus Conventional Type b Treatment
Authors hypothesize that thoracoabdominal aortic repair combined with bare metal stent implantation is superior over standard thoracoabdominal aortic repair.
Read the detailed description
Main hypothesis of this study is that thoracoabdominal aortic repair combined with bare metal stent implantation is better permanent neurological deficits, perioperative bleeding, malperfusion of viscera over conventional thoracoabdominal aortic repair.
- Conditions
- Aortic Dissection Type B
- Being tested
- Open thoracoabdominal aortic repair + abdominal stenting, Classic thoracoabdominal aortic repair
- Keywords
- Thoracic aorta, Abdominal aorta, Stents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open thoracoabdominal aortic repair + abdominal stentingProcedure or surgery
Also called Hybrid thoracoabdominal aortic repair
Thoracoabdominal aortic dissection (TAAD) repair + bare aortic stent (Djumbodis) implantation
Classic thoracoabdominal aortic repairProcedure or surgery
Also called Conventional TAAD repair
Thoracoabdominal aortic dissection (TAAD) repair
| Study group | Role | What they receive |
|---|---|---|
| Hybrid TAAD repair | Experimental | The group includes patients who underwent open thoracoabdominal aortic repair + abdominal stenting. Receives: Procedure: Open thoracoabdominal aortic repair + abdominal stenting |
| Conventional TAAD repair | Active comparator | The group includes patients who underwent classic thoracoabdominal aortic repair with dacron prosthesis. Receives: Procedure: Classic thoracoabdominal aortic repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Permanent neurological events
Quantity of permanent neurological events such as stroke and paraplegia by 30th day after procedure.
Measured: 30 days
Secondary outcomes (3)
Perioperative bleeding
Volume of perioperative and postoperative bleeding in ICU
Measured: 5 days after procedure
Mortality
Postoperative mortality will be measured during 6 months after procedure
Measured: 6 months
Visceral malperfusion
Clinical evidences of visceral malperfusion (acute or achronic abdomen ischemia) during 6 months after procedure (Yes or No)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2016 (estimated)
- Study startJan 2013
- Primary completionJan 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Dissection Type BStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Dmitry Sirota, Meshalkin Research Institute of Pathology of Circulation
- Investigators
- Alexander M. Chernyavskiy, MD PhD, Study chair, Academician Ye. Meshalkin Novosibirsk Research Institute of Circulation Pathology Ministry of Health care of Russian Federation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02726841
- Sponsor's protocol ID
- TAAD+bare stent
- Status last verified
- Sep 2017
- First submitted
- 27 Jan 2016
- Last updated
- 13 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Superiority Trial of Type b Aortic Dissection Treatment Combined With Implantation of Bare Metal Stent in Abdominal Part of Aorta Versus Conventional Type b Treatment
- ClinicalTrials.gov ID
- NCT02726841
- Acronym / sponsor ID
- TAAD+bare stent
- Conditions
- Aortic Dissection Type B
- Keywords
- Thoracic aorta, Abdominal aorta, Stents
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- Jan 2013
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 4 Apr 2016 (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.
Authors hypothesize that thoracoabdominal aortic repair combined with bare metal stent implantation is superior over standard thoracoabdominal aortic repair.
Detailed description
Main hypothesis of this study is that thoracoabdominal aortic repair combined with bare metal stent implantation is better permanent neurological deficits, perioperative bleeding, malperfusion of viscera over conventional thoracoabdominal aortic repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hybrid TAAD repair | Experimental | Procedure: Open thoracoabdominal aortic repair + abdominal stentingThe group includes patients who underwent open thoracoabdominal aortic repair + abdominal stenting. |
| Conventional TAAD repair | Active comparator | Procedure: Classic thoracoabdominal aortic repairThe group includes patients who underwent classic thoracoabdominal aortic repair with dacron prosthesis. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with chronic aortic dissection type B
- Aortic size in descending thoracoabdominal aorta (TAA) > 55 mm
Key exclusion criteria (5 listed)
- concomitant cardiac pathology
- concomitant oncology diseases in the last 5 years
- acute aortic dissection
- aortic size in visceral zone >45 mm
- connectivity tissue diseases
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 |
|---|---|---|
| Open thoracoabdominal aortic repair + abdominal stentingAlso: Hybrid thoracoabdominal aortic repairThoracoabdominal aortic dissection (TAAD) repair + bare aortic stent (Djumbodis) implantation | Procedure or surgery | Hybrid TAAD repair |
| Classic thoracoabdominal aortic repairAlso: Conventional TAAD repairThoracoabdominal aortic dissection (TAAD) repair | Procedure or surgery | Conventional TAAD repair |
Primary outcome
Permanent neurological events
Time frame: 30 days
Quantity of permanent neurological events such as stroke and paraplegia by 30th day after procedure.
3 secondary outcomes
Perioperative bleeding
Time frame: 5 days after procedure
Mortality
Time frame: 6 months
Visceral malperfusion
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2017.
- Individual participant dataSharing planned: No
Related trials for Aortic Dissection Type B
Recruiting
IMPRoving Outcomes in Vascular DisEase - Aortic Dissection
Type B Aortic Dissection
Recruiting
EXtensive mulTilayer stEnt treatmeNt in Aortic disSectiOn
Type B Aortic Dissection
Not yet recruitingObservational study
Type B Aortic Dissection Quality Control Platform
Endovascular Surgery, Medical Quality
Recruiting
WeFlow-EndoSeal™ Aorta Vascular Plug System for the Treatment of Stanford Type B Aortic Dissection
Aortic Dissection Type B
Enrolling by invitationObservational study
Outcomes of Aortic Dissection Repair
Type A Aortic Dissection, Ascending Aortic Dissection
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.
Alexander M. Chernyavskiy, MD PhD study chair
Academician Ye. Meshalkin Novosibirsk Research Institute of Circulation Pathology Ministry of Health care of Russian Federation
Questions about this trial
What is this clinical trial studying?
A study testing Open thoracoabdominal aortic repair + abdominal stenting and Classic thoracoabdominal aortic repair in people with Aortic Dissection Type B, run by Meshalkin Research Institute of Pathology of Circulation.
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 2 inclusion and 5 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 13 Sep 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Permanent neurological events (time frame: 30 days). 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 13 Sep 2017.