State of Non-operated Aortic SegmentsCASTLENCT03711136
Comparison of stAndard and Hybrid Surgical Techniques in the Treatment of proximaL Aortic dissEctions
An observational study of State of Non-operated Aortic Segments and Aorto-related Events, run by Novosibirsk Scientific Research Institute for Circulatory Pathology at 1 site in Russia.
Trial summary
The study is devoted to the evaluation of the results of surgical treatment of patients with proximal aortic dissection. Two groups of patients with standard and hybrid surgery are compared. Early and long-term postoperative results are evaluated. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- State of Non-operated Aortic Segments, Aorto-related Events
- What is being tested?
- aortic prosthesis
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jan 2018to 31 Aug 2018
- 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 80 years
- All sexes
- Adult, Older adult
Study population: patients with proximal aortic dissection operated using one of the techniques
Who may be able to join
- aortic dissection type A
Who cannot join
- age limits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Standard and Hybrid Techniques in Surgical Treatment of Proximal Aortic Dissection
The study is devoted to the evaluation of the results of surgical treatment of patients with proximal aortic dissection. Two groups of patients with standard and hybrid surgery are compared. Early and long-term postoperative results are evaluated.
- Being tested
- aortic prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aortic prosthesisProcedure or surgery
ascending aortic and/or aortic arch prosthesis with linear vascular prosthesis or hybrid prosthesis
| Study group | Role | What they receive |
|---|---|---|
| Frozen elephant trunk surgery | Not described Receives: Procedure: aortic prosthesis | |
| Standart surgery | Not described Receives: Procedure: aortic prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aorto-related events
Death, reoperations,thoracoabdomminal aneurysms
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start1 Jan 2018
- Primary completion1 May 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for State of Non-operated Aortic SegmentsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novosibirsk Scientific Research Institute for Circulatory Pathology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Edemskiy, Novosibirsk Scientific Research Institute for Circulatory Pathology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03711136
- Sponsor's protocol ID
- CASTLE
- Acronym
- CASTLE
- Status last verified
- Oct 2018
- First submitted
- 15 Oct 2018
- Last updated
- 18 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Standard and Hybrid Techniques in Surgical Treatment of Proximal Aortic Dissection
- ClinicalTrials.gov ID
- NCT03711136
- Acronym / sponsor ID
- CASTLE / CASTLE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Novosibirsk Scientific Research Institute for Circulatory PathologyUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 18 Oct 2018 (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.
The study is devoted to the evaluation of the results of surgical treatment of patients with proximal aortic dissection. Two groups of patients with standard and hybrid surgery are compared. Early and long-term postoperative results are evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Frozen elephant trunk surgery | – | Procedure: aortic prosthesis |
| Standart surgery | – | Procedure: aortic prosthesis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients with proximal aortic dissection operated using one of the techniques
Key inclusion criteria (1 listed)
- aortic dissection type A
Key exclusion criteria (1 listed)
- age limits
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 |
|---|---|---|
| aortic prosthesisascending aortic and/or aortic arch prosthesis with linear vascular prosthesis or hybrid prosthesis | Procedure or surgery | Frozen elephant trunk surgery, Standart surgery |
Primary outcome
Aorto-related events
Time frame: 3 years
Death, reoperations,thoracoabdomminal aneurysms
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2018.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 State of Non-operated Aortic Segments and Aorto-related Events, run by Novosibirsk Scientific Research Institute for Circulatory Pathology at 1 site in Russia.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 18 Oct 2018. 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 Russia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Aorto-related events (time frame: 3 years). 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 18 Oct 2018.