Aortic Dissection
Conditions
Keywords
descending, thoracic, aortic, dissection, Valiant, Medtronic, Type B, VIRTUE, stent
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.
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.
Interventions
None listed
Sponsors
Medtronic Endovascular
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| Safety | 30 days or at discharge, 3/6/12/24/36 months | * All causes mortality * Disease-, procedure- or device-related mortality |
| 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 |
| 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) |
| 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. |
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 details
No subject got excluded after enrollment
Participants by arm
| Arm | Count |
|---|---|
| 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. | 50 |
| 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. | 24 |
| 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. | 26 |
| Total | 100 |
Baseline characteristics
| Characteristic | Sub-acute | Chronic | Acute | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 7 Participants | 25 Participants | 38 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 19 Participants | 25 Participants | 62 Participants |
| Age Continuous | 59.7 years STANDARD_DEVIATION 11 | 58.8 years STANDARD_DEVIATION 10.9 | 63.2 years STANDARD_DEVIATION 14.1 | 61.2 years STANDARD_DEVIATION 12.7 |
| Region of Enrollment Europe | 24 participants | 26 participants | 50 participants | 100 participants |
| Sex: Female, Male Female | 6 Participants | 6 Participants | 12 Participants | 24 Participants |
| Sex: Female, Male Male | 18 Participants | 20 Participants | 38 Participants | 76 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 50 | 2 / 24 | 1 / 26 |
| serious Total, serious adverse events | 35 / 50 | 15 / 24 | 19 / 26 |
Outcome results
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.
Time frame: 12 months post-procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Acute | Disease-, Procedure- or Device-related Mortality at 12 Months Post-procedure | 9 participants |
| Sub-acute | Disease-, Procedure- or Device-related Mortality at 12 Months Post-procedure | 1 participants |
| Chronic | Disease-, Procedure- or Device-related Mortality at 12 Months Post-procedure | 1 participants |
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)
Time frame: through 36 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Acute | Clinical Success | 18 participants |
| Sub-acute | Clinical Success | 9 participants |
| Chronic | Clinical Success | 8 participants |
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
Time frame: 30 days or at discharge, 3/6/12/24/36 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Acute | Efficacy/Performance | 49 participants |
| Sub-acute | Efficacy/Performance | 24 participants |
| Chronic | Efficacy/Performance | 25 participants |
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.
Time frame: through 36 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Acute | Freedom From Disease-, Procedure- or Device-related Major Complications | 37.4 Percentage Event Free |
| Sub-acute | Freedom From Disease-, Procedure- or Device-related Major Complications | 41.3 Percentage Event Free |
| Chronic | Freedom From Disease-, Procedure- or Device-related Major Complications | 40.3 Percentage Event Free |
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
Time frame: through 36 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Acute | Freedom From Disease-, Procedure-, or Device-related Severe Complications | 67.8 Percentage Event Free |
| Sub-acute | Freedom From Disease-, Procedure-, or Device-related Severe Complications | 75.0 Percentage Event Free |
| Chronic | Freedom From Disease-, Procedure-, or Device-related Severe Complications | 64.1 Percentage Event Free |
Secondary
Freedom of Re-intervention
Kaplan-Meier estimate of freedom from secondary procedures by clinical group.
Time frame: 30 days or at discharge, 3/6/12/24/36 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Acute | Freedom of Re-intervention | 71.7 Percentage Event Free |
| Sub-acute | Freedom of Re-intervention | 68.8 Percentage Event Free |
| Chronic | Freedom of Re-intervention | 66.7 Percentage Event Free |
Secondary
Safety
* All causes mortality * Disease-, procedure- or device-related mortality
Time frame: 30 days or at discharge, 3/6/12/24/36 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Acute | Safety | 9 participants |
| Sub-acute | Safety | 1 participants |
| Chronic | Safety | 6 participants |