Trial Outcomes & Findings for The VIRTUE Post Marketing Surveillance Registry (NCT NCT01213589)

NCT ID: NCT01213589

Last Updated: 2013-12-11

Results Overview

Disease, device or procedure-related mortality at 12 months post-procedure, defined as any death related to the device, to the disease or to the surgical procedure occurring in the period of 365 days following the day of the implant procedure.

• Recruitment status: COMPLETED
• Target enrollment: 100 participants
• Primary outcome timeframe: 12 months post-procedure
• Results posted on: 2013-12-11

Participant Flow

Enrollment of study patients in the Registry began in the medical clinics on 5 December 2006 and was completed on 26 August 2009.

No subject got excluded after enrollment

Participant milestones

Measure	Acute Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.	Sub-acute Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.	Chronic Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.
Overall Study STARTED	50	24	26
Overall Study COMPLETED	37	19	18
Overall Study NOT COMPLETED	13	5	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The VIRTUE Post Marketing Surveillance Registry

Baseline characteristics by cohort

Measure	Acute n=50 Participants Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.	Sub-acute n=24 Participants Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.	Chronic n=26 Participants Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=93 Participants	18 Participants n=4 Participants	19 Participants n=27 Participants	62 Participants n=483 Participants
Age, Categorical >=65 years	25 Participants n=93 Participants	6 Participants n=4 Participants	7 Participants n=27 Participants	38 Participants n=483 Participants
Age Continuous	63.2 years STANDARD_DEVIATION 14.1 • n=93 Participants	59.7 years STANDARD_DEVIATION 11.0 • n=4 Participants	58.8 years STANDARD_DEVIATION 10.9 • n=27 Participants	61.2 years STANDARD_DEVIATION 12.7 • n=483 Participants
Sex: Female, Male Female	12 Participants n=93 Participants	6 Participants n=4 Participants	6 Participants n=27 Participants	24 Participants n=483 Participants
Sex: Female, Male Male	38 Participants n=93 Participants	18 Participants n=4 Participants	20 Participants n=27 Participants	76 Participants n=483 Participants
Region of Enrollment Europe	50 participants n=93 Participants	24 participants n=4 Participants	26 participants n=27 Participants	100 participants n=483 Participants

PRIMARY outcome

Timeframe: 12 months post-procedure

Disease, device or procedure-related mortality at 12 months post-procedure, defined as any death related to the device, to the disease or to the surgical procedure occurring in the period of 365 days following the day of the implant procedure.

Outcome measures

Measure	Acute n=50 Participants Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.	Sub-acute n=24 Participants Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.	Chronic n=26 Participants Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.
Disease-, Procedure- or Device-related Mortality at 12 Months Post-procedure	9 participants	1 participants	1 participants

SECONDARY outcome

Timeframe: 30 days or at discharge, 3/6/12/24/36 months

• All causes mortality
• Disease-, procedure- or device-related mortality

Outcome measures

Measure	Acute n=50 Participants Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.	Sub-acute n=24 Participants Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.	Chronic n=26 Participants Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.
Safety	9 participants	1 participants	6 participants

SECONDARY outcome

Timeframe: 30 days or at discharge, 3/6/12/24/36 months

• Technical Success Technical success, defined as a composite of (i) successful introduction and deployment of at least one Valiant Thoracic Stent Graft at the intended location, (ii) successful coverage of the proximal entry tear, (iii) no immediate conversion to open surgery during the same intervention, (iv) absence of death within 24 hours post-procedure, and (v) the absence of significant graft twist, kink or obstruction by intra-operative measurements

Outcome measures

Measure	Acute n=50 Participants Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.	Sub-acute n=24 Participants Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.	Chronic n=26 Participants Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.
Efficacy/Performance	49 participants	24 participants	25 participants

SECONDARY outcome

Timeframe: 30 days or at discharge, 3/6/12/24/36 months

Kaplan-Meier estimate of freedom from secondary procedures by clinical group.

Outcome measures

Measure	Acute n=50 Participants Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.	Sub-acute n=24 Participants Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.	Chronic n=26 Participants Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.
Freedom of Re-intervention	71.7 Percentage Event Free	68.8 Percentage Event Free	66.7 Percentage Event Free

SECONDARY outcome

Timeframe: through 36 months

Complications were assigned a severity score (according SVS scores) so that degrees of morbidity can be assessed and compared. A moderate complication indicates the need for significant intervention, prolongation of hospitalization more than 24 hours, and at most, minor permanent disability that does not preclude normal daily activity. A severe complication necessitates major surgical or medical intervention, may be associated with prolonged convalescence, is usually accompanied by prolonged or permanent disability, and may result in death. Both moderate and severe complications are considered as major complications.

Kaplan-Meier estimate of freedom from disease-, procedure-, or device-related major complications by clinical group.

Outcome measures

Measure	Acute n=50 Participants Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.	Sub-acute n=24 Participants Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.	Chronic n=26 Participants Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.
Freedom From Disease-, Procedure- or Device-related Major Complications	37.4 Percentage Event Free	41.3 Percentage Event Free	40.3 Percentage Event Free

SECONDARY outcome

Timeframe: through 36 months

Complications were assigned a severity score (according SVS scores) so that degrees of morbidity can be assessed and compared. A severe complication necessitates major surgical or medical intervention, may be associated with prolonged convalescence, is usually accompanied by prolonged or permanent disability, and may result in death.

Kaplan-Meier estimate of freedom from disease-, procedure-, or device-related severe complications

Outcome measures

Measure	Acute n=50 Participants Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.	Sub-acute n=24 Participants Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.	Chronic n=26 Participants Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.
Freedom From Disease-, Procedure-, or Device-related Severe Complications	67.8 Percentage Event Free	75.0 Percentage Event Free	64.1 Percentage Event Free

SECONDARY outcome

Timeframe: through 36 months

Clinical success was defined as: (i) successful introduction and deployment of the Valiant Thoracic Stent Graft at the intended location; (ii) successful coverage of the proximal entry tear; (iii) no immediate conversion to open surgery;(iv) absence of surgical open repair or endovascular re-intervention; (v) absence of death related to aortic disease or treatment; (vi) absence of graft thrombosis, obstructions, twists or kinks; (vii) absence of graft migration;(viii) absence of graft integrity failure; (ix) at the level of the ostium of the LSA, the more proximal entry tear of the dissection, the largest section of the thoracic aorta, and at the first image/slice available with upper part of the liver:

Absence of true lumen decrease in diameter (≥ 5 mm is significant) Absence of increase in total aortic diameter (≥ 5 mm is significant)

Outcome measures

Measure	Acute n=50 Participants Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.	Sub-acute n=24 Participants Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.	Chronic n=26 Participants Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.
Clinical Success	18 participants	9 participants	8 participants

Adverse Events

Acute

Serious events: 35 serious events

Other events: 3 other events

Deaths: 0 deaths

Sub-acute

Serious events: 15 serious events

Other events: 2 other events

Deaths: 0 deaths

Chronic

Serious events: 19 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Acute n=50 participants at risk Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.	Sub-acute n=24 participants at risk Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.	Chronic n=26 participants at risk Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.
Respiratory, thoracic and mediastinal disorders Pulmonary Complications (General)	26.0% 13/50	12.5% 3/24	19.2% 5/26
Cardiac disorders Cardiac and Hemodynamic (General)	34.0% 17/50	12.5% 3/24	26.9% 7/26
Gastrointestinal disorders GI (General)	12.0% 6/50	8.3% 2/24	7.7% 2/26
Vascular disorders Arterial	36.0% 18/50	29.2% 7/24	23.1% 6/26

Other adverse events

Measure	Acute n=50 participants at risk Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.	Sub-acute n=24 participants at risk Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.	Chronic n=26 participants at risk Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.
Renal and urinary disorders Renal Complications (General)	6.0% 3/50	8.3% 2/24	3.8% 1/26

Additional Information

Richard Jonkers, PhD

Medtronic

Phone: 800-217-1617

Email: richard.jonkers@medtronic.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60