Aortic Aneurysm, Thoracic
Conditions
Keywords
Stent graft, thoracic aorta, dissection, aneurysm, TEVAR, VALIANT, CAPTIVIA, endovascular
Brief summary
The Valiant Thoracic Stent Graft has been preloaded on the new Captivia Delivery System (Captivia). This new delivery system was CE marked on September 14th, 2009 and was commercially released in the European Union on October 1st, 2009. The Valiant Thoracic Stent Graft with the Captivia Delivery System (Valiant Captivia) is designed to treat diseases of the descending thoracic aorta including but not limited to aneurysms and dissections. The purpose of the VALIANT CAPTIVIA Registry is to collect and evaluate mid term clinical performance data of the Valiant Captivia Thoracic Stent Graft System following OUS market approval.
Detailed description
1. Use of controls 1. This study is a post-market registry without using a control. All analyses will be descriptive in nature and no statistical comparisons are planned. Sample size 2. There is no sample size calculation since this is not a hypothesis driven study; VALIANT CAPTIVIA has recruited 100 subjects and will follow these subjects through for approximately 36 months. 2. Number of investigation sites and study duration 1. 15 investigation sites in Europe and Turkey where the Valiant Captivia Thoracic Stent Graft System is commercially available have enrolled 100 subjects. 2. There will be no minimum nor maximum number of enrolled subjects per investigation site. 3. The sites' compliance with the clinical investigation plan will be assessed on an ongoing basis. In case of serious non-compliance, the sponsor may decide to stop subject enrolment in a site based on the assessment.
Interventions
DEVICETEVAR
Thoracic endovascular aneurysm repair
Sponsors
Medtronic Cardiovascular
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years or minimum age as required by local regulations * Indication for surgical repair of thoracic aortic aneurysms and/or thoracic aortic dissections with an thoracic endovascular stent graft in accordance with the applicable guidelines on endovascular interventions and the Instructions for Use of the Valiant Captivia Thoracic Stent Graft System * Signed consent form ('Patient informed consent form' or 'Patient Data Release Authorization Form') * Intention to implant the Valiant Captivia Thoracic Stent Graft System or having implanted the system within the last 3 months before subject enrollment * Willingness and ability to comply with the CIP
Exclusion criteria
* High probability of non-adherence to physician's follow-up requirements * Participation in concurrent interventional trial which may confound study results * Prior implantation of a thoracic stent graft
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Success | at 12 months | technical success and freedom from * TAA diameter increase of stented segment (\>5mm compared to 1 mo), * Types I/III endoleak, * Aneurysm rupture, * Conversion to open surgery, * Stent graft occlusion, * Stent graft migration resulting in SAE or secondary intervention. |
| Technical Success at Time of Initial Implant | intraoperatively | Technical success is defined as successful delivery and deployment of the stent graft (assessed intraoperatively). This is achieved by deployment of the Valiant Thoracic Stent Graft in the planned location with no unintentional coverage of the left subclavian artery, left common carotid artery and/or brachiocephalic artery and with the removal of the delivery system |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SAE | through 12 months | Serious Adverse Events (SAE) |
| ACM and ARM | at 30 days, 12 months, 24 months and 36 months | All-cause (ACM), Aneurysm related (ARM) and dissection related mortality |
Countries
Austria, Germany, Italy, Netherlands, Spain, Turkey (Türkiye), United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients Undergoing TEVAR Those with a thoracic aortic aneurysm/dissection\>
\> TEVAR: Thoracic endovascular aneurysm repair | 100 |
| Total | 100 |
Baseline characteristics
| Characteristic | Patients Undergoing TEVAR |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 48 Participants |
| Age, Categorical Between 18 and 65 years | 52 Participants |
| Age, Continuous | 65.0 year |
| Native aorta diameter | 32 mm |
| Region of Enrollment Austria | 2 participants |
| Region of Enrollment Germany | 24 participants |
| Region of Enrollment Italy | 17 participants |
| Region of Enrollment Netherlands | 16 participants |
| Region of Enrollment Spain | 5 participants |
| Region of Enrollment Turkey | 15 participants |
| Region of Enrollment United Kingdom | 21 participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 81 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 100 |
| serious Total, serious adverse events | 48 / 100 |
Outcome results
Primary
Technical Success at Time of Initial Implant
Technical success is defined as successful delivery and deployment of the stent graft (assessed intraoperatively). This is achieved by deployment of the Valiant Thoracic Stent Graft in the planned location with no unintentional coverage of the left subclavian artery, left common carotid artery and/or brachiocephalic artery and with the removal of the delivery system
Time frame: intraoperatively
Population: The primary and secondary endpoints will be reported descriptively.~By-gender and by-race data summaries for the primary endpoints, if appropriate, will be generated. Data from all study sites will be grouped together for analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1 - Medtronic VCOUS | Technical Success at Time of Initial Implant | 100 participants |
Primary
Treatment Success
technical success and freedom from * TAA diameter increase of stented segment (\>5mm compared to 1 mo), * Types I/III endoleak, * Aneurysm rupture, * Conversion to open surgery, * Stent graft occlusion, * Stent graft migration resulting in SAE or secondary intervention.
Time frame: at 12 months
Population: The number of participants analyzed are different for each endpoint based on number of evaluable subjects at each timepoint per endpoint.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1 - Medtronic VCOUS | Treatment Success | 9 Participants |
| 2 - Medtronic VCOUS | Treatment Success | 4 Participants |
| 3 - Medtronic VCOUS | Treatment Success | 4 Participants |
| 4 - Medtronic VCOUS | Treatment Success | 0 Participants |
| 5 - Medtronic VCOUS | Treatment Success | 2 Participants |
| 6 - Medtronic VCOUS | Treatment Success | 1 Participants |
Secondary
ACM and ARM
All-cause (ACM), Aneurysm related (ARM) and dissection related mortality
Time frame: at 30 days, 12 months, 24 months and 36 months
Secondary
SAE
Serious Adverse Events (SAE)
Time frame: through 12 months
Population: The primary and secondary endpoints will be reported descriptively.~By-gender and by-race data summaries for the primary endpoints, if appropriate, will be generated. Data from all study sites will be grouped together for analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1 - Medtronic VCOUS | SAE | 48 participants |