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Endovascular Repair for the Descending Thoracic Aorta (ERRATA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02376998
Recruitment Status : Completed
First Posted : March 3, 2015
Results First Posted : October 7, 2016
Last Update Posted : October 7, 2016
Sponsor:
Information provided by (Responsible Party):
Prof. Raffaele Serra, MD, Ph.D., University of Catanzaro

Tracking Information
First Submitted Date  ICMJE February 12, 2015
First Posted Date  ICMJE March 3, 2015
Results First Submitted Date  ICMJE May 24, 2016
Results First Posted Date  ICMJE October 7, 2016
Last Update Posted Date October 7, 2016
Study Start Date  ICMJE November 2002
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 15, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 25, 2015)
Early Outcomes [ Time Frame: from hospital discharge to 1 month after the procedure ]
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2015)
Long Term Outcomes [ Time Frame: after 1 month from the procedure ]
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Endovascular Repair for the Descending Thoracic Aorta
Official Title  ICMJE Endovascular Repair for Acute Traumatic Transection of the Descending Thoracic Aorta
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
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Aorta Thoracic; Traumatic Rupture
Intervention  ICMJE Device: Valiant™ endoluminal procedure

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 Arms  ICMJE Experimental: Valiant™ endoluminal procedure
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.
Intervention: Device: Valiant™ endoluminal procedure
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 25, 2015)
20
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients who do not fall into the above categories
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02376998
Other Study ID Numbers  ICMJE ERRATASTUDY
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Prof. Raffaele Serra, MD, Ph.D., University of Catanzaro
Study Sponsor  ICMJE University of Catanzaro
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Catanzaro
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP