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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

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Aorta Thoracic; Traumatic Rupture
Intervention Device: Valiant™ endoluminal procedure
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Patients With Acute Transection of Thoracic Aorta
Hide Arm/Group Description Patients with a diagnosis of acute transection of thoracic aorta.
Period Title: Overall Study
Started 20
Completed 11
Not Completed 9
Arm/Group Title Patients With Acute Transection of Thoracic Aorta
Hide Arm/Group Description Patients with a diagnosis of acute transection of thoracic aorta.
Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 11 participants
36.9
(18 to 53)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
2
  18.2%
Male
9
  81.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Italy Number Analyzed 11 participants
11
1.Primary Outcome
Title Number of Participants With Major Adverse Events
Hide Description Evaluation of mortality, renal failure, cerebrovascular accident.
Time Frame from hospital discharge to 1 month after the procedure
Hide Outcome Measure Data
Hide Analysis Population Description
No serious adverse events recorded
Arm/Group Title Patients With Acute Transection of Thoracic Aorta
Hide Arm/Group Description:
Patients with a diagnosis of acute transection of thoracic aorta. Mortality 0%
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: number of serious adverse events
0
Time Frame 1 month
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Valiant™ Endoluminal Procedure
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Valiant™ Endoluminal Procedure
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Valiant™ Endoluminal Procedure
Affected / at Risk (%)
Total   0/11 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Valiant™ Endoluminal Procedure
Affected / at Risk (%)
Total   0/11 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Prof. Raffaele Serra
Organization: University Magna Graecia of Catanzaro
Phone: +3909613647380
EMail: rserra@unicz.it
Layout table for additonal information
Responsible Party: Prof. Raffaele Serra, MD, Ph.D., University of Catanzaro
ClinicalTrials.gov Identifier: NCT02376998    
Other Study ID Numbers: ERRATASTUDY
First Submitted: February 12, 2015
First Posted: March 3, 2015
Results First Submitted: May 24, 2016
Results First Posted: October 7, 2016
Last Update Posted: October 7, 2016