Endovascular Repair for the Descending Thoracic Aorta

NCT02376998 | Completed Results DMC

• 1 other identifier: ERRATASTUDY
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Conditions

Aorta Thoracic; Traumatic Rupture

Keywords

Thoracic Aorta; Trauma; Endovascular

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Major Adverse Events

  Evaluation of mortality, renal failure, cerebrovascular accident.

  from hospital discharge to 1 month after the procedure

Study Arms (1)

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.

Device: Valiant™ endoluminal procedure

Interventions

Valiant™ endoluminal procedure DEVICE

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.

Valiant™ endoluminal procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with a diagnosis of acute transection of thoracic aorta;
• a time frame range from trauma of 1-10 hours.

You may not qualify if:

• Patients who do not fall into the above categories

Sponsors & Collaborators

• University of Catanzaro: lead

Related Publications (1)

• 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.

  PMID: 26590963 DERIVED

MeSH Terms

Conditions

Wounds and Injuries

Results Point of Contact

• Title: Prof. Raffaele Serra
• Organization: University Magna Graecia of Catanzaro

rserra@unicz.it

+3909613647380

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Raffaele Serra

Study Record Dates

• First Submitted: February 12, 2015
• First Posted: March 3, 2015
• Study Start: November 1, 2002
• Primary Completion: November 1, 2014
• Study Completion: February 1, 2015
• Last Updated: October 7, 2016
• Results First Posted: October 7, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share