Trial Outcomes & Findings for VALIANT CAPTIVIA Post-market Registry (NCT NCT01181947)
NCT ID: NCT01181947
Last Updated: 2023-11-08
Results Overview
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.
Recruitment status
TERMINATED
Target enrollment
100 participants
Primary outcome timeframe
at 12 months
Results posted on
2023-11-08
Participant Flow
Participant milestones
| Measure |
Patients Undergoing TEVAR
Those with a thoracic aortic aneurysm/dissection\>
\> TEVAR: Thoracic endovascular aneurysm repair
|
|---|---|
|
Overall Study
STARTED
|
100
|
|
Overall Study
COMPLETED
|
100
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
VALIANT CAPTIVIA Post-market Registry
Baseline characteristics by cohort
| Measure |
Patients Undergoing TEVAR
n=100 Participants
Those with a thoracic aortic aneurysm/dissection\>
\> TEVAR: Thoracic endovascular aneurysm repair
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
52 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
48 Participants
n=5 Participants
|
|
Age, Continuous
|
65.0 year
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
81 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Turkey
|
15 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
16 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
24 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
21 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
17 participants
n=5 Participants
|
|
Native aorta diameter
|
32 mm
n=5 Participants
|
PRIMARY outcome
Timeframe: at 12 monthsPopulation: The number of participants analyzed are different for each endpoint based on number of evaluable subjects at each timepoint per endpoint.
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.
Outcome measures
| Measure |
1 - Medtronic VCOUS
n=57 Participants
TAA Diameter \> 5mm at 12 months
|
2 - Medtronic VCOUS
n=61 Participants
Type I/III Endoleak at 12 months
|
3 - Medtronic VCOUS
n=100 Participants
Aneurysm Rupture within 12 months
|
4 - Medtronic VCOUS
n=98 Participants
Stent Graft Occlusion within 12 months
|
5 - Medtronic VCOUS
n=100 Participants
Conversion to Surgery within 12 months
|
6 - Medtronic VCOUS
n=64 Participants
Stent Graft Migration \> 10 mm resulting in SAE or requiring secondary intervention at 12 months
|
|---|---|---|---|---|---|---|
|
Treatment Success
|
9 Participants
|
4 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: intraoperativelyPopulation: 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.
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
Outcome measures
| Measure |
1 - Medtronic VCOUS
n=100 Participants
TAA Diameter \> 5mm at 12 months
|
2 - Medtronic VCOUS
Type I/III Endoleak at 12 months
|
3 - Medtronic VCOUS
Aneurysm Rupture within 12 months
|
4 - Medtronic VCOUS
Stent Graft Occlusion within 12 months
|
5 - Medtronic VCOUS
Conversion to Surgery within 12 months
|
6 - Medtronic VCOUS
Stent Graft Migration \> 10 mm resulting in SAE or requiring secondary intervention at 12 months
|
|---|---|---|---|---|---|---|
|
Technical Success at Time of Initial Implant
|
100 participants
Interval 96.4 to 100.4
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: through 12 monthsPopulation: 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.
Serious Adverse Events (SAE)
Outcome measures
| Measure |
1 - Medtronic VCOUS
n=100 Participants
TAA Diameter \> 5mm at 12 months
|
2 - Medtronic VCOUS
Type I/III Endoleak at 12 months
|
3 - Medtronic VCOUS
Aneurysm Rupture within 12 months
|
4 - Medtronic VCOUS
Stent Graft Occlusion within 12 months
|
5 - Medtronic VCOUS
Conversion to Surgery within 12 months
|
6 - Medtronic VCOUS
Stent Graft Migration \> 10 mm resulting in SAE or requiring secondary intervention at 12 months
|
|---|---|---|---|---|---|---|
|
SAE
|
48 participants
Interval 40.0 to 58.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at 30 days, 12 months, 24 months and 36 monthsAll-cause (ACM), Aneurysm related (ARM) and dissection related mortality
Outcome measures
Outcome data not reported
Adverse Events
1. VCOUS
Serious events: 48 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1. VCOUS
n=100 participants at risk
Medtronic VCOUS
|
|---|---|
|
Cardiac disorders
Arrhythmia
|
1.0%
1/100 • Number of events 1 • 12 months
|
|
Cardiac disorders
Cardiac Arrest
|
3.0%
3/100 • Number of events 3 • 12 months
|
|
Cardiac disorders
Cardiac Failure Congestive
|
1.0%
1/100 • Number of events 1 • 12 months
|
|
Cardiac disorders
Hypertension
|
1.0%
1/100 • Number of events 1 • 12 months
|
|
Eye disorders
Diplopia
|
1.0%
1/100 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
3.0%
3/100 • Number of events 3 • 12 months
|
|
Gastrointestinal disorders
Intestinal Ischaemia
|
3.0%
3/100 • Number of events 3 • 12 months
|
|
Gastrointestinal disorders
Vomiting
|
1.0%
1/100 • Number of events 1 • 12 months
|
|
General disorders
Death
|
1.0%
1/100 • Number of events 1 • 12 months
|
|
General disorders
Inflammatory Marker Increased
|
1.0%
1/100 • Number of events 1 • 12 months
|
|
General disorders
Multi-Organ Failure
|
2.0%
2/100 • Number of events 2 • 12 months
|
|
General disorders
Stent-Graft Endoleak
|
9.0%
9/100 • Number of events 9 • 12 months
|
|
General disorders
Systemic Inflammatory Response Syndrome
|
2.0%
2/100 • Number of events 2 • 12 months
|
|
Infections and infestations
Endocarditis
|
1.0%
1/100 • Number of events 1 • 12 months
|
|
Infections and infestations
Graft Infection
|
1.0%
1/100 • Number of events 1 • 12 months
|
|
Infections and infestations
Sepsis
|
1.0%
1/100 • Number of events 1 • 12 months
|
|
Infections and infestations
Urinary Tract Infection
|
1.0%
1/100 • Number of events 1 • 12 months
|
|
Infections and infestations
Wound Infection
|
1.0%
1/100 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Vascular Bypass Dysfunction
|
1.0%
1/100 • Number of events 1 • 12 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.0%
1/100 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.0%
2/100 • Number of events 2 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Compartment Syndrome
|
1.0%
1/100 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Carcinoma
|
1.0%
1/100 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
1.0%
1/100 • Number of events 1 • 12 months
|
|
Nervous system disorders
Cerebrovascular Accident
|
6.0%
6/100 • Number of events 6 • 12 months
|
|
Nervous system disorders
Grand Mal Convulsion
|
1.0%
1/100 • Number of events 1 • 12 months
|
|
Nervous system disorders
Intracranial Aneurysm
|
1.0%
1/100 • Number of events 1 • 12 months
|
|
Nervous system disorders
Neuropathy Peripheral
|
1.0%
1/100 • Number of events 1 • 12 months
|
|
Nervous system disorders
Paraplegia
|
1.0%
1/100 • Number of events 1 • 12 months
|
|
Psychiatric disorders
Agitation
|
1.0%
1/100 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Renal Failure
|
2.0%
2/100 • Number of events 2 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
1.0%
1/100 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.0%
1/100 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Depression
|
1.0%
1/100 • Number of events 2 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Vocal Cord Paresis
|
1.0%
1/100 • Number of events 1 • 12 months
|
|
Vascular disorders
Aneurysm Repair
|
1.0%
1/100 • Number of events 1 • 12 months
|
|
Vascular disorders
Aortic Aneurysm
|
3.0%
3/100 • Number of events 4 • 12 months
|
|
Vascular disorders
Aortic Dissection
|
3.0%
3/100 • Number of events 3 • 12 months
|
|
Vascular disorders
Aortic Rupture
|
4.0%
4/100 • Number of events 4 • 12 months
|
|
Vascular disorders
Arterial Thrombosis
|
1.0%
1/100 • Number of events 1 • 12 months
|
|
Vascular disorders
Arteriovenous Fistula
|
1.0%
1/100 • Number of events 1 • 12 months
|
|
Vascular disorders
Haematoma
|
2.0%
2/100 • Number of events 3 • 12 months
|
|
Vascular disorders
Haemothorax
|
1.0%
1/100 • Number of events 1 • 12 months
|
|
Vascular disorders
Peripheral Artery Stenosis
|
1.0%
1/100 • Number of events 1 • 12 months
|
|
Vascular disorders
Peripheral Ischaemia
|
1.0%
1/100 • Number of events 1 • 12 months
|
|
Vascular disorders
Procedural Haemorrhage
|
3.0%
3/100 • Number of events 3 • 12 months
|
|
Vascular disorders
Vascular Dissection
|
1.0%
1/100 • Number of events 1 • 12 months
|
|
Vascular disorders
Vascular Pseudoaneurysm
|
1.0%
1/100 • Number of events 1 • 12 months
|
|
Vascular disorders
Vessel Puncture Site Haematoma
|
1.0%
1/100 • Number of events 1 • 12 months
|
Other adverse events
| Measure |
1. VCOUS
n=100 participants at risk
Medtronic VCOUS
|
|---|---|
|
Social circumstances
headache
|
5.0%
5/100 • Number of events 5 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Medical Center or Investigator may, at his/her discretion, publish and/or present publicly the results of the work of Medical Center and/or Investigator performed under this Agreement. However, should Medical Center or Investigator contemplate publishing and/or presenting publicly such results, the Investigator shall provide copies of any abstracts, papers, or manuscripts to Medtronic for review at least 90 (ninety) days prior to submittal for publication or presentation.
- Publication restrictions are in place
Restriction type: OTHER