Aorta Thoracic; Traumatic RuptureERRATANCT02376998
Endovascular Repair for the Descending Thoracic Aorta
A study testing Valiant™ endoluminal procedure in people with Aorta Thoracic; Traumatic Rupture, run by University of Catanzaro.
Trial summary
Most blunt aortic injuries occur in the proximal proximal descending aorta causing acute transection of this vessel. Generally, surgical repair of the ruptured segment of aorta is associated with high rates of morbidity and mortality and in this view endovascular treatment seems to be a valid and safer alternative. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aorta Thoracic; Traumatic Rupture
- What is being tested?
- Valiant™ endoluminal procedure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Nov 2002to Feb 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- patients with a diagnosis of acute transection of thoracic aorta;
- a time frame range from trauma of 1-10 hours.
Who cannot join
- Patients who do not fall into the above categories
About this study
Official title: Endovascular Repair for Acute Traumatic Transection of the Descending Thoracic Aorta
Most blunt aortic injuries occur in the proximal proximal descending aorta causing acute transection of this vessel. Generally, surgical repair of the ruptured segment of aorta is associated with high rates of morbidity and mortality and in this view endovascular treatment seems to be a valid and safer alternative. Aim of this study is to review the experience of a single center with endovascular approach for the treatment of acute traumatic rupture of descending thoracic aorta
Read the detailed description
From April 2002 to November 2014, patients referred to our Department with a diagnosis of acute transection of thoracic aorta will be studied by preoperative Computed Tomography (CT) evaluation in order to perform thoracic endovascular aortic repair (TEVAR) with left subclavian artery coverage. Then patients will be followed up with clinical and instrumental (CT, Duplex ultrasound) controls at discharge, 1, 3 and 6 months and yearly thereafter. We will evaluate the presence of major and minor neurological complications, episodes of left arm claudication, cardiovascular, respiratory and bleeding complications. Furthermore we will evaluate the technical success of the technique evaluating the onset of failure, collapse, leak or distal migration of the graft.
- Conditions
- Aorta Thoracic; Traumatic Rupture
- Being tested
- Valiant™ endoluminal procedure
- Keywords
- Thoracic Aorta, Trauma, Endovascular
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valiant™ endoluminal procedureDevice
Thoracic endovascular aortic repair with Endoluminal stent-graft placement (Valiant™ endoluminal stent-graft systems (Medtronic Inc., Santa Rosa, CA, USA) will be performed as follows:
The diameter of the stent graft will be calculated from the largest diameter of the proximal/distal neck with an oversizing factor of 10-20%. The procedures will be done with local or general anaesthesia in case of unstable pre-operative hemodynamic conditions.
After the procedure will be completed, a digital subtraction angiography and echocardiography with color-flow mapping were performed to verify the correct positioning of the stent and to detect any primary endoleak.
| Study group | Role | What they receive |
|---|---|---|
| Valiant™ endoluminal procedure | Experimental | Data from early and long term complications following endoluminal stent-graft placement for thoracic endovascular aortic repair (TEVAR) procedure (Valiant™ endoluminal procedure) will be collected. Receives: Device: Valiant™ endoluminal procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Major Adverse Events
Evaluation of mortality, renal failure, cerebrovascular accident.
Measured: from hospital discharge to 1 month after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startNov 2002
- Primary completionNov 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aorta Thoracic; Traumatic RuptureStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Catanzaro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Raffaele Serra, MD, Ph.D., University of Catanzaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02376998
- Sponsor's protocol ID
- ERRATASTUDY
- Acronym
- ERRATA
- Status last verified
- Aug 2016
- First submitted
- 12 Feb 2015
- Last updated
- 7 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Serra R, de Franciscis S, Grande R, Butrico L, Perri P, Indolfi C, Mastroroberto P. Endovascular repair for acute traumatic transection of the descending thoracic aorta: experience of a single centre with a 12-years follow up. J Cardiothorac Surg. 2015 Nov 21;10:171. doi: 10.1186/s13019-015-0388-5.
PubMed 26590963
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endovascular Repair for Acute Traumatic Transection of the Descending Thoracic Aorta
- ClinicalTrials.gov ID
- NCT02376998
- Acronym / sponsor ID
- ERRATA / ERRATASTUDY
- Conditions
- Aorta Thoracic; Traumatic Rupture
- Keywords
- Thoracic Aorta, Trauma, Endovascular
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of CatanzaroUniversity, hospital or other
- Study start
- Nov 2002
- Primary completion
- Nov 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 3 Mar 2015 (estimated)
- Results
- Posted 7 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Most blunt aortic injuries occur in the proximal proximal descending aorta causing acute transection of this vessel. Generally, surgical repair of the ruptured segment of aorta is associated with high rates of morbidity and mortality and in this view endovascular treatment seems to be a valid and safer alternative. Aim of this study is to review the experience of a single center with endovascular approach for the treatment of acute traumatic rupture of descending thoracic aorta
Detailed description
From April 2002 to November 2014, patients referred to our Department with a diagnosis of acute transection of thoracic aorta will be studied by preoperative Computed Tomography (CT) evaluation in order to perform thoracic endovascular aortic repair (TEVAR) with left subclavian artery coverage. Then patients will be followed up with clinical and instrumental (CT, Duplex ultrasound) controls at discharge, 1, 3 and 6 months and yearly thereafter. We will evaluate the presence of major and minor neurological complications, episodes of left arm claudication, cardiovascular, respiratory and bleeding complications. Furthermore we will evaluate the technical success of the technique evaluating the onset of failure, collapse, leak or distal migration of the graft.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Valiant™ endoluminal procedure | Experimental | Device: Valiant™ endoluminal procedureData from early and long term complications following endoluminal stent-graft placement for thoracic endovascular aortic repair (TEVAR) procedure (Valiant™ endoluminal procedure) will be collected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients with a diagnosis of acute transection of thoracic aorta;
- a time frame range from trauma of 1-10 hours.
Key exclusion criteria (1 listed)
- Patients who do not fall into the above categories
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 |
|---|---|---|
| Valiant™ endoluminal procedureThoracic endovascular aortic repair with Endoluminal stent-graft placement (Valiant™ endoluminal stent-graft systems (Medtronic Inc., Santa Rosa, CA, USA) will be performed as follows: The diameter of the stent graft will be calculated from the largest diameter of the proximal/distal neck with an oversizing factor of 10-20%. The procedures will be done with local or general anaesthesia in case of unstable pre-operative hemodynamic conditions. After the procedure will be completed, a digital subtraction angiography and echocardiography with color-flow mapping were performed to verify the correct positioning of the stent and to detect any primary endoleak. | Device | Valiant™ endoluminal procedure |
Primary outcome
Number of Participants With Major Adverse Events
Time frame: from hospital discharge to 1 month after the procedure
Evaluation of mortality, renal failure, cerebrovascular accident.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26590963Serra R, de Franciscis S, Grande R, Butrico L, Perri P, Indolfi C, Mastroroberto P. Endovascular repair for acute traumatic transection of the descending thoracic aorta: experience of a single centre with a 12-years follow up. J Cardiothorac Surg. 2015 Nov 21;10:171. doi: 10.1186/s13019-015-0388-5.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Valiant™ endoluminal procedure in people with Aorta Thoracic; Traumatic Rupture, run by University of Catanzaro.
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 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 7 Oct 2016. 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?
Yes. Results are posted in the registry (first posted 7 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Major Adverse Events (time frame: from hospital discharge to 1 month after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02376998, which also lists 1 linked publication.
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 7 Oct 2016.