The VIRTUE Post Marketing Surveillance Registry

• Sponsor: Medtronic Endovascular (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01213589
• Collaborator: (none)
• Enrollment: 100
• Duration (Months): 70

Study Details

Study Description

Brief Summary

The purpose of this post-market release registry is to collect additional information concerning safety, performance and health economic data with respect to the Medtronic VALIANT Thoracic Stent Graft with the Xcelerant Delivery System in the treatment of descending thoracic aortic dissections.

Condition or Disease	Intervention/Treatment	Phase
Aortic Dissection

Detailed Description

The patient device for use in this registry is the Medtronic VALIANT Thoracic Stent Graft System that received CE mark approval in March 2005.

The Medtronic VALIANT Thoracic Stent Graft with Xcelerant Delivery System is designed to treat diseases of the descending thoracic aorta including but not limited to aneurysms and dissections. The VALIANT Stent Graft is designed to exclude the aneurysm, the false lumen or site of rupture and restore the blood flow through the stent graft lumen. The device is intended for use either in patients who are candidates for conventional surgical repair, and in patients who are not candidates for conventional surgical repair due to pre-existing risk factors.

This registry is a prospective, non-randomized, single-arm, multi-center, European clinical registry with patients diagnosed with descending thoracic aortic dissection.

For this registry standard hospital procedures with respect to patient interventional care for thoracic aortic diseases will be followed.

This is a descriptive registry in which no specific hypotheses will be statistically tested.

Study Design

• Study Type: Observational
• Actual Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The VIRTUE Post Marketing Surveillance Registry - VALIANT Thoracic Stent Graft Evaluation For the Treatment of Descending Thoracic Aortic Dissections
• Study Start Date: Dec 1, 2006
• Actual Primary Completion Date: Oct 1, 2012
• Actual Study Completion Date: Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Descending thoracic aortic dissection 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 either an acute, sub-acute or chronic Type B dissection.

Outcome Measures

Primary Outcome Measures

1. Disease-, Procedure- or Device-related Mortality at 12 Months Post-procedure [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.

Secondary Outcome Measures

1. Safety [30 days or at discharge, 3/6/12/24/36 months]

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

2. Efficacy/Performance [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

3. Freedom of Re-intervention [30 days or at discharge, 3/6/12/24/36 months]

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

4. Freedom From Disease-, Procedure- or Device-related Major Complications [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.

5. Freedom From Disease-, Procedure-, or Device-related Severe Complications [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

6. Clinical Success [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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patient will be more than or equal to 18 years of age; or older if required by local regulations.

• Patient has an indication for treatment by either endovascular stent graft implantation for either an acute, sub-acute or chronic Type B dissection.

• Patient is amenable for stent-graft treatment (in accordance with the IFU).

• The patient is willing and able to cooperate with registry procedures and required follow-up visits.

• The patient or legal guardian has signed a patient informed consent form, including data privacy authorization (this criteria is not applicable for patients presenting in emergency with ruptured dissection and for whom legal representative is not available informed consent can be requested after surgical procedure).

Exclusion Criteria:

• Patients with a thoracic dissection for which optimal treatment is observation and medical management.

• Patient with current - non aortic - medical condition with a life expectancy less than one year.

• The patient is participating in another device or drug study (patient must have completed the follow-up phase of any previous study at least 30 days prior to enrolment in this registry).

• Time interval between medical indication for surgical intervention and endovascular procedure exceeds 4 months (122 days).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Medtronic Endovascular

Investigators

• Principal Investigator: M. Thompson, Prof., St George's Hospital
• Principal Investigator: D. Gasparini, Dr., Azienda Ospedaliera "Santa Maria della Misericordia"
• Principal Investigator: R. Fattori, Prof., Ospedale Sant'Orsola Malpighi
• Principal Investigator: P. Cao, Dr., Unità di Chirurgia Vascolare, Ospedale R. Silvestrini
• Principal Investigator: G. Garzón, Dr., Hospital Universitario La Paz
• Principal Investigator: E. Ros, Prof., Hospital Clínico Universitario San Cecilio
• Principal Investigator: B. Rylski, Dr., Universitätsklinikum Freiburg
• Principal Investigator: S. Huptas, Dr., Universitätsklinikum Essen
• Principal Investigator: I. Degrieck, Dr., Onze-Lieve-Vrouw Ziekenhuis
• Principal Investigator: D. Dai-DoDo, Prof., Universitätsspital Bern, Inselspital
• Principal Investigator: H. Roos, Dr., Sahlgrenska University Hospital, Sweden
• Principal Investigator: R. Heijmen, Dr., St. Antonius ziekenhuis
• Principal Investigator: N. Cheshire, Prof., St Mary's NHS Trust
• Principal Investigator: C. Nienaber, Dr, University School of Medicine Rostock

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medtronic Endovascular
• ClinicalTrials.gov Identifier: NCT01213589
• Other Study ID Numbers: MDTVIRTUE001
• First Posted: Oct 4, 2010
• Last Update Posted: Dec 11, 2013
• Last Verified: Oct 1, 2013

• Keywords provided by Medtronic Endovascular: descending; thoracic; aortic; dissection; Valiant; Medtronic; Type B; VIRTUE; stent
• Additional relevant MeSH terms: Aneurysm, Dissecting

Study Results

Participant Flow

Recruitment Details	Enrollment of study patients in the Registry began in the medical clinics on 5 December 2006 and was completed on 26 August 2009.
Pre-assignment Detail	No subject got excluded after enrollment

Arm/Group Title	Acute	Sub-acute	Chronic
Arm/Group Description	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.	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.	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.
Period Title: Overall Study
STARTED	50	24	26
COMPLETED	37	19	18
NOT COMPLETED	13	5	8

Baseline Characteristics

Arm/Group Title	Acute	Sub-acute	Chronic	Total
Arm/Group Description	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.	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.	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 of all reporting groups
Overall Participants	50	24	26	100
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	25 50%	18 75%	19 73.1%	62 62%
>=65 years	25 50%	6 25%	7 26.9%	38 38%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.2 (14.1)	59.7 (11.0)	58.8 (10.9)	61.2 (12.7)
Sex: Female, Male (Count of Participants)
Female	12 24%	6 25%	6 23.1%	24 24%
Male	38 76%	18 75%	20 76.9%	76 76%
Region of Enrollment (participants) [Number]
Europe	50 100%	24 100%	26 100%	100 100%

Outcome Measures

1. Primary Outcome

Title	Disease-, Procedure- or Device-related Mortality at 12 Months Post-procedure
Description	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.
Time Frame	12 months post-procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acute	Sub-acute	Chronic
Arm/Group Description	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.	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.	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.
Measure Participants	50	24	26
Number [participants]	9 18%	1 4.2%	1 3.8%

2. Secondary Outcome

Title	Safety
Description	All causes mortality Disease-, procedure- or device-related mortality
Time Frame	30 days or at discharge, 3/6/12/24/36 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acute	Sub-acute	Chronic
Arm/Group Description	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.	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.	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.
Measure Participants	50	24	26
Number [participants]	9 18%	1 4.2%	6 23.1%

3. Secondary Outcome

Title	Efficacy/Performance
Description	- 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
Time Frame	30 days or at discharge, 3/6/12/24/36 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acute	Sub-acute	Chronic
Arm/Group Description	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.	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.	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.
Measure Participants	50	24	26
Number [participants]	49 98%	24 100%	25 96.2%

4. Secondary Outcome

Title	Freedom of Re-intervention
Description	Kaplan-Meier estimate of freedom from secondary procedures by clinical group.
Time Frame	30 days or at discharge, 3/6/12/24/36 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acute	Sub-acute	Chronic
Arm/Group Description	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.	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.	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.
Measure Participants	50	24	26
Number [Percentage Event Free]	71.7	68.8	66.7

5. Secondary Outcome

Title	Freedom From Disease-, Procedure- or Device-related Major Complications
Description	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.
Time Frame	through 36 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acute	Sub-acute	Chronic
Arm/Group Description	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.	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.	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.
Measure Participants	50	24	26
Number [Percentage Event Free]	37.4	41.3	40.3

6. Secondary Outcome

Title	Freedom From Disease-, Procedure-, or Device-related Severe Complications
Description	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
Time Frame	through 36 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acute	Sub-acute	Chronic
Arm/Group Description	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.	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.	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.
Measure Participants	50	24	26
Number [Percentage Event Free]	67.8	75.0	64.1

7. Secondary Outcome

Title	Clinical Success
Description	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)
Time Frame	through 36 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acute	Sub-acute	Chronic
Arm/Group Description	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.	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.	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.
Measure Participants	50	24	26
Number [participants]	18 36%	9 37.5%	8 30.8%

Adverse Events

Arm/Group Title	Acute		Sub-acute		Chronic
Arm/Group Description	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.		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.		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.
All Cause Mortality
	Acute		Sub-acute		Chronic
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Acute		Sub-acute		Chronic
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	35/50 (70%)		15/24 (62.5%)		19/26 (73.1%)
Cardiac disorders
Cardiac and Hemodynamic (General)	17/50 (34%)		3/24 (12.5%)		7/26 (26.9%)
Gastrointestinal disorders
GI (General)	6/50 (12%)		2/24 (8.3%)		2/26 (7.7%)
Respiratory, thoracic and mediastinal disorders
Pulmonary Complications (General)	13/50 (26%)		3/24 (12.5%)		5/26 (19.2%)
Vascular disorders
Arterial	18/50 (36%)		7/24 (29.2%)		6/26 (23.1%)
Other (Not Including Serious) Adverse Events
	Acute		Sub-acute		Chronic
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/50 (6%)		2/24 (8.3%)		1/26 (3.8%)
Renal and urinary disorders
Renal Complications (General)	3/50 (6%)		2/24 (8.3%)		1/26 (3.8%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.