Ascending Aorta AneurismEPSTAAANCT01456975
Extravalvular Procedure for Surgical Treatment of Ascending Aorta Aneurism
A study testing Aortic valve reimplantation using Valsalva prosthesis in people with Ascending Aorta Aneurism and Aortic Insufficiency, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
Trial summary
The investigators expect that the using of prothesis with sinuses has more benefits for long term competence and condition of aortic valve than the using of straight prothesis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ascending Aorta Aneurism, Aortic Insufficiency
- What is being tested?
- Aortic valve reimplantation using Valsalva prosthesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteRussia
- Study dates
- Jan 2007to Jan 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
- Aortic insufficiency 2+
- Ascending aorta size more than 5 cm
- Ascending aorta size more than 4,5 cm (Marfan syndrome)
- Good conditions of aortic cusps
Who cannot join
- Aortic annulus more than 30 mm
- Aortic cusps destruction
- Critical aortic cusps elongation
- Aortic root dissection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reimplantation Procedure for Surgical Treatment of Ascending Aorta Aneurism With Concomitant Aortic Valve Insufficiency
The investigators expect that the using of prothesis with sinuses has more benefits for long term competence and condition of aortic valve than the using of straight prothesis.
- Conditions
- Ascending Aorta Aneurism, Aortic Insufficiency
- Being tested
- Aortic valve reimplantation using Valsalva prosthesis
- Keywords
- Ascending aorta aneurism, Aortic insufficiency
- Medical subject headings
- Aortic Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aortic valve reimplantation using Valsalva prosthesisProcedure or surgery
Also called Gelweave Vascutek Valsalva
Aortic valve reimplantation (David procedure)using Valsalva prosthesis
| Study group | Role | What they receive |
|---|---|---|
| Valsalva | Experimental | Reimplantation procedure using Valsalva prosthesis Receives: Procedure: Aortic valve reimplantation using Valsalva prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
all causes of aortic valve replacement
Aortic insufficiency (AI) measured by echocardiography. If AI more than 2+, aortic valve replacement performed
Measured: before discharging (average of 2 weeks after surgery)
Secondary outcomes (1)
all causes of death after procedure
Aortic insufficiency (AI) measured by echocardiography. If AI more than 2+, aortic valve replacement performed
Measured: 6, 12, 24,36,48,60,72, 84, 96 months after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2011 (estimated)
- Study startJan 2007
- Primary completionDec 2012
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ascending Aorta AneurismStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01456975
- Sponsor's protocol ID
- EVAPRO
- Acronym
- EPSTAAA
- Status last verified
- Sep 2015
- First submitted
- 27 Sep 2011
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reimplantation Procedure for Surgical Treatment of Ascending Aorta Aneurism With Concomitant Aortic Valve Insufficiency
- ClinicalTrials.gov ID
- NCT01456975
- Acronym / sponsor ID
- EPSTAAA / EVAPRO
- Conditions
- Ascending Aorta Aneurism, Aortic Insufficiency
- Keywords
- Ascending aorta aneurism, Aortic insufficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- Jan 2007
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2017 (estimated)
- First posted
- 21 Oct 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 investigators expect that the using of prothesis with sinuses has more benefits for long term competence and condition of aortic valve than the using of straight prothesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Valsalva | Experimental | Procedure: Aortic valve reimplantation using Valsalva prosthesisReimplantation procedure using Valsalva prosthesis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aortic insufficiency 2+
- Ascending aorta size more than 5 cm
- Ascending aorta size more than 4,5 cm (Marfan syndrome)
- Good conditions of aortic cusps
Key exclusion criteria (4 listed)
- Aortic annulus more than 30 mm
- Aortic cusps destruction
- Critical aortic cusps elongation
- Aortic root dissection
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 valve reimplantation using Valsalva prosthesisAlso: Gelweave Vascutek ValsalvaAortic valve reimplantation (David procedure)using Valsalva prosthesis | Procedure or surgery | Valsalva |
Primary outcome
all causes of aortic valve replacement
Time frame: before discharging (average of 2 weeks after surgery)
Aortic insufficiency (AI) measured by echocardiography. If AI more than 2+, aortic valve replacement performed
1 secondary outcome
all causes of death after procedure
Time frame: 6, 12, 24,36,48,60,72, 84, 96 months after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
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?
A study testing Aortic valve reimplantation using Valsalva prosthesis in people with Ascending Aorta Aneurism and Aortic Insufficiency, run by Meshalkin Research Institute of Pathology of Circulation 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 4 inclusion and 4 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 23 Sep 2015. 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?
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?
all causes of aortic valve replacement (time frame: before discharging (average of 2 weeks after 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 23 Sep 2015.