Aortic AneurysmPhase 4ATLANTISNCT01107366
ATLANTIS:Extensive Type A Dissections and Thoracic/ Thoraco-Abdominal Aneurysms Repair With LupiAe Hybrid TechNique
A Phase 4 study testing lupiae technique in people with Aortic Aneurysm, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
To prospectively evaluate the safety and efficacy of the LUPIAE hybrid technique for the treatment of thoracic or thoraco-abdominal aortic aneurysms thoracic aortic type A dissections 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm
- What is being tested?
- lupiae technique
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2010to Dec 2012
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient willing to sign the informed consent, or In case of acute patients that should arrive at the hospital in unconsciousness status, patient's first degree relatives willingness to sign the informed consent and patient's willingness to re-consent for the study participation once he/she is again conscious.
- and
- Patients with extensive thoracic or thoraco-abdominal aortic aneurysms (>55 mm diameter), involving the ascending, arch and descending aortic segments, but not involving the renal arteries (at least 15 mm of healthy tissue above the most proximal renal artery).
- Or
- Patients with extensive type A aortic dissection (DeBakey type I) with at least one of the following minimum criteria:
- An initial false lumen diameter measured in the upper descending thoracic aorta >22 mm;
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- Total aortic diameter measured in the descending thoracic aorta >45 mm;
- True lumen's compression (True lumen <10% of total aortic lumen);
- Non-controlled hypertension;
- Persistent pain;
- Rupture or imminent rupture;
Who cannot join
- Patient has a standard contraindication to the implant of thoracic stent graft;
- Patient unable to commit to follow-up schedule;
- Patient has medical conditions that preclude protocol required testing or limit study participation;
- Patient is enrolled or intend to participate in another clinical trial during the course of this study;
- Less than 18 years of age;
- Pregnancy;
- A life expectancy of less than one year, except for Patients with extensive type A aortic dissection (DeBakey type I)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Extensive Type A Dissections and Thoracic/ Thoraco-Abdominal
To prospectively evaluate the safety and efficacy of the LUPIAE hybrid technique for the treatment of
- thoracic or thoraco-abdominal aortic aneurysms
- thoracic aortic type A dissections 2. to compare the safety and efficacy of the LUPIAE hybrid technique with historical groups (literature review, other hybrid techniques, LUPIAE retrospective patients)
Read the detailed description
LUPIAE technique:
Hybrid repair of thoracic or thoraco-abdominal aneurysms of different etiology and type A dissections with a two-stage procedure:
- surgical arch reconstruction with a Dacron multibranched surgical prothesis
- endovascular implantation of a thoracic stent graft
- Conditions
- Aortic Aneurysm
- Being tested
- lupiae technique
- Keywords
- lupiae techinque, aortic aneurism, aortic dissection
- Medical subject headings
- Aortic Aneurysm, Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lupiae techniqueProcedure or surgery
it's a new hybrid technique for the treatment of aortic aneurism and dissection.
lupiae techniqueProcedure or surgery
LUPIAE technique
Hybrid repair of thoracic or thoraco-abdominal aneurysms of different etiology and type A dissections with a two-stage procedure:
- surgical arch reconstruction with a Dacron multibranched surgical prothesis
- endovascular implantation of a thoracic stent graft
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality
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 Apr 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Why it stopped: The study never started since our Medical Ethic Commeettee did not approved it
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic AneurysmStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01107366
- Sponsor's protocol ID
- ATLANTIS BOLOGNA
- Acronym
- ATLANTIS
- Status last verified
- Jun 2011
- First submitted
- 20 Apr 2010
- Last updated
- 28 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extensive Type A Dissections and Thoracic/ Thoraco-Abdominal
- ClinicalTrials.gov ID
- NCT01107366
- Acronym / sponsor ID
- ATLANTIS / ATLANTIS BOLOGNA
- Conditions
- Aortic Aneurysm
- Keywords
- lupiae techinque, aortic aneurism, aortic dissection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study never started since our Medical Ethic Commeettee did not approved it
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 21 Apr 2010 (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.
To prospectively evaluate the safety and efficacy of the LUPIAE hybrid technique for the treatment of
- thoracic or thoraco-abdominal aortic aneurysms
- thoracic aortic type A dissections 2. to compare the safety and efficacy of the LUPIAE hybrid technique with historical groups (literature review, other hybrid techniques, LUPIAE retrospective patients)
Detailed description
LUPIAE technique:
Hybrid repair of thoracic or thoraco-abdominal aneurysms of different etiology and type A dissections with a two-stage procedure:
- surgical arch reconstruction with a Dacron multibranched surgical prothesis
- endovascular implantation of a thoracic stent graft
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patient willing to sign the informed consent, or In case of acute patients that should arrive at the hospital in unconsciousness status, patient's first degree relatives willingness to sign the informed consent and patient's willingness to re-consent for the study participation once he/she is again conscious.
- and
- Patients with extensive thoracic or thoraco-abdominal aortic aneurysms (>55 mm diameter), involving the ascending, arch and descending aortic segments, but not involving the renal arteries (at least 15 mm of healthy tissue above the most proximal renal artery).
- Or
- Patients with extensive type A aortic dissection (DeBakey type I) with at least one of the following minimum criteria:
Key exclusion criteria (7 listed)
- Patient has a standard contraindication to the implant of thoracic stent graft;
- Patient unable to commit to follow-up schedule;
- Patient has medical conditions that preclude protocol required testing or limit study participation;
- Patient is enrolled or intend to participate in another clinical trial during the course of this study;
- Less than 18 years of age;
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 |
|---|---|---|
| lupiae techniqueit's a new hybrid technique for the treatment of aortic aneurism and dissection. | Procedure or surgery | – |
| lupiae techniqueLUPIAE technique Hybrid repair of thoracic or thoraco-abdominal aneurysms of different etiology and type A dissections with a two-stage procedure: 1. surgical arch reconstruction with a Dacron multibranched surgical prothesis 2. endovascular implantation of a thoracic stent graft | Procedure or surgery | – |
Primary outcome
all cause mortality
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2011.
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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.
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 Phase 4 study testing lupiae technique in people with Aortic Aneurysm, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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 11 inclusion and 7 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: withdrawn, as of the sponsor's last update on 28 Jun 2011. 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 Italy. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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 cause mortality (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 28 Jun 2011.