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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Disease-, Procedure- or Device-related Mortality at 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. | 12 months post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Safety |
| 30 days or at discharge, 3/6/12/24/36 months |
| Efficacy/Performance | - 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation will be enrolled in the registry.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20952217 | Result | Virtue Registry Investigators. The VIRTUE Registry of type B thoracic dissections--study design and early results. Eur J Vasc Endovasc Surg. 2011 Feb;41(2):159-66. doi: 10.1016/j.ejvs.2010.08.016. Epub 2010 Oct 16. |
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No subject got excluded after enrollment
Enrollment of study patients in the Registry began in the medical clinics on 5 December 2006 and was completed on 26 August 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Sub-acute |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Disease-, Procedure- or Device-related Mortality at 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. | Posted | Number | participants | 12 months post-procedure |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary Complications (General) | Respiratory, thoracic and mediastinal disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Renal Complications (General) | Renal and urinary disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard Jonkers, PhD | Medtronic | 800-217-1617 | 3727 | richard.jonkers@medtronic.com |
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| ID | Term |
|---|---|
| D000784 | Aortic Dissection |
| ID | Term |
|---|---|
| D000094665 | Dissection, Blood Vessel |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| 30 days or at discharge, 3/6/12/24/36 months |
| Freedom of Re-intervention | Kaplan-Meier estimate of freedom from secondary procedures by clinical group. | 30 days or at discharge, 3/6/12/24/36 months |
| Freedom From Disease-, Procedure- or Device-related Major Complications | 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. | through 36 months |
| Freedom From Disease-, Procedure-, or Device-related Severe Complications | 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 | through 36 months |
| Clinical Success | 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) | through 36 months |
| D. Dai-DoDo, Prof. |
| Universitätsspital Bern, Inselspital |
| Principal Investigator |
| H. Roos, Dr. | Sahlgrenska University Hospital | Principal Investigator |
| R. Heijmen, Dr. | St. Antonius Hospital | Principal Investigator |
| N. Cheshire, Prof. | St Mary's NHS Trust | Principal Investigator |
| C. Nienaber, Dr | University School of Medicine Rostock | Principal Investigator |
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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | 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. |
|
|
| Secondary | Safety |
| Posted | Number | participants | 30 days or at discharge, 3/6/12/24/36 months |
|
|
|
| Secondary | Efficacy/Performance | - 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 | Posted | Number | participants | 30 days or at discharge, 3/6/12/24/36 months |
|
|
|
| Secondary | Freedom of Re-intervention | Kaplan-Meier estimate of freedom from secondary procedures by clinical group. | Posted | Number | Percentage Event Free | 30 days or at discharge, 3/6/12/24/36 months |
|
|
|
| Secondary | Freedom From Disease-, Procedure- or Device-related Major Complications | 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. | Posted | Number | Percentage Event Free | through 36 months |
|
|
|
| Secondary | Freedom From Disease-, Procedure-, or Device-related Severe Complications | 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 | Posted | Number | Percentage Event Free | through 36 months |
|
|
|
| Secondary | Clinical Success | 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) | Posted | Number | participants | through 36 months |
|
|
|
| 35 |
| 50 |
| 3 |
| 50 |
| EG001 | 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. | 15 | 24 | 2 | 24 |
| EG002 | 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. | 19 | 26 | 1 | 26 |
| Cardiac and Hemodynamic (General) | Cardiac disorders |
|
| GI (General) | Gastrointestinal disorders |
|
| Arterial | Vascular disorders |
|
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| D000094683 |
| Acute Aortic Syndrome |
| D001018 | Aortic Diseases |