Valiant Evo International Clinical Trial
Sponsor
Medtronic Cardiovascular (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02625324
Collaborator
(none)
100
16
1
92
6.3
0.1
Study Details
Study Description
Brief Summary
The purpose of the Valiant Evo International Clinical Trial is to demonstrate the safety and effectiveness of the Valiant Evo Thoracic Stent Graft System in subjects with a descending thoracic aortic aneurysm (DTAA) who are candidates for endovascular repair.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 total subjects, in order obtain 87 evaluable subjects for the primary endpoint. The two protocols are identical, and the trials were run simultaneously to enroll subjects concurrently in the United States (US) and Outside United States (OUS). The poolability on the primary endpoint between US and OUS data will be assessed using Fisher's exact test during the data analysis. Data for both trials will be combined and presented as a pooled analysis.
Study Design
Study Type:
Interventional
Actual Enrollment
:
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Valiant Evo International Clinical Trial
Actual Study Start Date
:
Apr 1, 2016
Actual Primary Completion Date
:
Dec 1, 2017
Anticipated Study Completion Date
:
Dec 1, 2023
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Endovascular repair Valiant Evo Thoracic Stent Graft System |
Device: Valiant Evo Thoracic Stent Graft System
Procedure: thoracic endovascular aneurysm repair (TEVAR)
|
Outcome Measures
Primary Outcome Measures
- Composite Safety and Effectiveness Endpoint That is Based on the Percentage of Subjects Who Experienced (a) Access and/or Deployment Failures; and/or (b) Major Device Effect (MDE) Within 30 Days Post Index Procedure [30 Days]
MDEs include: device-related secondary procedures, device-related mortality, conversion to open surgery, thoracic aortic aneurysm rupture. Access failure: Inability to insert device due to mechanical failure or anatomic exclusions of the femoral or iliac arteries. Deployment failure: Deployment failure due to subject anatomy or mechanical failure. Specifically, deployment of the stent graft from the delivery system. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the primary endpoint global cohort of 87 subjects. The poolability on the primary endpoint between US and OUS data were assessed using Fisher's exact test.
Secondary Outcome Measures
- Safety and Effectiveness Outcome [30 Days]
Safety and Effectiveness outcome measures between 0-30 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 Outside US [OUS]). Measures include: peri-operative mortality, adverse events (AE), major adverse events (MAE), serious adverse events (SAE), secondary procedures, loss of stent graft patency, and endoleaks.
- Safety and Effectiveness Outcome [6 Month]
Safety outcome measures between 0-183 days and Effectiveness outcome measures between 31-183 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort. Safety measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE) and secondary procedures. Effectiveness measures include loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month.
- Safety and Effectiveness Outcome [12 Month]
Safety outcome measures between 0-365 days and Effectiveness outcome measures between 184-365 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort. Safety measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE) and secondary procedures. Effectiveness measures include loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month.
- Safety and Effectiveness Outcome [24 Month]
Safety outcome measures between 0-730 days and Effectiveness outcome measures between 366-730 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort. Safety measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE) and secondary procedures. Effectiveness measures include loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month.
- Safety and Effectiveness Outcome [36 Month]
Safety outcome measures between 0-1095 days and Effectiveness outcome measures between 731-1095 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort. Safety measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE) and secondary procedures. Effectiveness measures include loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month.
- Safety and Effectiveness Outcome [48 month]
Safety and effectiveness outcome measure between implant procedure and 48 months. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort. Measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE), secondary procedures, loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month.
- Safety and Effectiveness Outcome [60 Month]
Safety and Effectiveness outcome measures between implant procedure and 60 months. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort. Measures include: aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE), secondary procedures, loss of stent graft patency, stent graft migration compared to 1 month imaging, aneurysm expansion greater than 5 mm compared to 1 month imaging, and endoleaks.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Subject is ≥18 years old
-
Subject understands and voluntarily has signed and dated the Patient Informed Consent approved by the Sponsor and by the Ethics Committee for this study
-
Subject presents a DTAA which is localized below the ostium of left subclavian artery (LSA) and above the ostium of celiac trunk
-
Subject has a DTAA that is one of the following:
-
A fusiform aneurysm with a maximum diameter that:
-
is ≥ 50 mm and/or:
-
is ≥ 2 times the diameter of the non-aneurysmal thoracic aorta and/or:
-
is <50 mm and has grown ≥ 5 mm within previous 12 months
-
A saccular aneurysm or a penetrating atherosclerotic ulcer
-
Subject's anatomy must meet all of the following anatomical criteria as demonstrated on contrast-enhanced CT and/or on contrast-enhanced MRI obtained within four (4) months prior to implant procedure:
-
Proximal and distal non-aneurysmal aortic neck diameter measurements must be ≥ 16 mm and ≤ 42 mm
-
Proximal non-aneurysmal aortic neck length must be ≥ 20 mm (for FreeFlo configuration) and ≥ 25 mm (for Closed Web configuration)
-
Distal non-aneurysmal aortic neck length must be ≥ 20 mm
-
Subject has adequate arterial access site or can tolerate a conduit that allows endovascular access to the aneurysmal site with the delivery system of the appropriate sized device chosen for the treatment.
Exclusion Criteria:
-
Subject has a life expectancy of less than 1 year
-
Subject is participating in another investigational drug or device study which would interfere with the endpoints and follow-ups of this study
-
Subject is pregnant
-
Subject requires planned placement of the covered proximal end of the stent graft to occur in zones 0 or 1
-
Subject has a thoracic aneurysm with a contained rupture or localized at the anastomosis of a previous graft (pseudo-/false aneurysm)
-
Subject has a mycotic aneurysm
-
Subject has a dissection (type A or B) or an intramural hematoma or an aortic rupture in addition to the thoracic aneurysm
-
Subject requires emergent aneurysm treatment, e.g., trauma or rupture
-
Subject has received a previous stent or stent graft or previous surgical repair in the ascending and/or descending thoracic aorta, and/or in the aortic arch
-
Subject requires surgical or endovascular treatment of an infra-renal aneurysm at the time of implant
-
Subject has had previous surgical or endovascular treatment of an infra-renal aortic aneurysm
-
Treatment with the Valiant Evo Thoracic Stent Graft would require intentional revascularization of the brachio-cephalic artery, the left common carotid artery or the celiac trunk
-
Subject has had or plans to have a major surgical or interventional procedure within 30 days before or 30 days after the planned implantation of the Valiant Evo Thoracic Stent Graft. This does not include planned procedures that are needed for the safe and effective placement of the stent graft (i.e., carotid/subclavian transposition, carotid/subclavian bypass procedure)
-
Subject has a significant and/or circumferential aortic mural thrombus at either the proximal or distal attachment sites that could compromise fixation and seal of the implanted stent graft
-
Subject has a connective tissue disease (e.g., Marfan's syndrome, aortic medial degeneration)
-
Subject has a bleeding diathesis or coagulopathy, or refuses blood transfusion.
-
Subject has had a myocardial infarction (MI) within 3 months of the procedure
-
Subject has had a Cerebrovascular Accident (CVA) within 3 months of the procedure
-
Subject has a known allergy or intolerance to the device materials
-
Subject has a known allergy to anesthetic drugs
-
Subject has a known hypersensitivity or contraindication to anticoagulants, or contrast media, which is not amenable to pretreatment
-
Subject has active or systemic infection at the time of the index procedure
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | London Health Sciences Centre - Victoria Hospital | London | Canada | ||
| 2 | Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ) | Quebec | Canada | ||
| 3 | Odense Universitetshospital | Odense | Denmark | ||
| 4 | Centre Chirurgical Marie Lannelongue | Le Plessis-Robinson | France | ||
| 5 | CHU de Montpellier - Hôpital Arnaud de Villeneuve | Montpellier | France | ||
| 6 | Hôpitaux Universitaires de Strasbourg - Nouvel Hôpital Civil | Strasbourg | France | ||
| 7 | Policlinico Sant' Orsola - Malpighi | Bologna | Italy | ||
| 8 | IRCCS Ca' Granda Ospendale Maggiore Policlinico | Milano | Italy | ||
| 9 | Ospedale San Raffaele - Milano | Milano | Italy | ||
| 10 | Università di Perugia - Ospedale S.M. Della Misericordia | Perugia | Italy | ||
| 11 | IRCCS Policlinico San Donato | San Donato Milanese | Italy | ||
| 12 | Maastricht Universitair Medisch Centrum (MUMC) | Maastricht | Netherlands | ||
| 13 | St. Antonius Ziekenhuis | Nieuwegein | Netherlands | ||
| 14 | Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital | Cambridge | United Kingdom | ||
| 15 | Imperial College Healthcare NHS Trust - St Mary's Hospital | London | United Kingdom | ||
| 16 | Saint George's Healthcare NHS Trust | London | United Kingdom |
Sponsors and Collaborators
- Medtronic Cardiovascular
Investigators
- Principal Investigator: Fabio Verzini, Prof., A.O.U. Citta della Salute e della Scienza
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Medtronic Cardiovascular
ClinicalTrials.gov Identifier:
NCT02625324
Other Study ID Numbers:
- 10219493DOC
First Posted:
Dec 9, 2015
Last Update Posted:
Jun 28, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | 100 subjects (53 US, 47 Outside US [OUS]), from 18 US sites and 15 OUS sites, contributed to the global cohort. The 1st subject was enrolled on 25 April 2016 (US) & on 08 June 2016 (OUS), the 100th subject on 28 March 2018. |
|---|---|
| Pre-assignment Detail | A total of 152 subjects were consented to be reviewed for enrollment. 52 subjects were not approved for implantation, 100 subjects were approved for implantation. The 30-day primary endpoint was evaluated when 87 subjects completed 30-day follow-up. |
| Arm/Group Title | Endovascular Repair |
|---|---|
| Arm/Group Description | Subjects who were appropriate candidates for endovascular repair of Descending Thoracic Aortic Aneurysms (DTAA) and who met the inclusion and exclusion criteria. |
| Period Title: 30-Day Follow-up for Primary Endpoint | |
| STARTED | 87 |
| COMPLETED | 86 |
| NOT COMPLETED | 1 |
| Period Title: 30-Day Follow-up for Primary Endpoint | |
| STARTED | 100 |
| COMPLETED | 99 |
| NOT COMPLETED | 1 |
| Period Title: 30-Day Follow-up for Primary Endpoint | |
| STARTED | 99 |
| COMPLETED | 91 |
| NOT COMPLETED | 8 |
| Period Title: 30-Day Follow-up for Primary Endpoint | |
| STARTED | 91 |
| COMPLETED | 87 |
| NOT COMPLETED | 4 |
| Period Title: 30-Day Follow-up for Primary Endpoint | |
| STARTED | 87 |
| COMPLETED | 53 |
| NOT COMPLETED | 34 |
| Period Title: 30-Day Follow-up for Primary Endpoint | |
| STARTED | 53 |
| COMPLETED | 49 |
| NOT COMPLETED | 4 |
Baseline Characteristics
| Arm/Group Title | Endovascular Repair |
|---|---|
| Arm/Group Description | Subjects who were appropriate candidates for endovascular repair of Descending Thoracic Aortic Aneurysm (DTAA) and who met the inclusion and exclusion criteria. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 Outside US [OUS]). |
| Overall Participants | 100 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
70.8
(8.9)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
40
40%
|
| Male |
60
60%
|
| Race/Ethnicity, Customized (Count of Participants) | |
| White |
42
42%
|
| Non-White |
11
11%
|
| Region of Enrollment (participants) [Number] | |
| Canada |
7
7%
|
| Netherlands |
4
4%
|
| Denmark |
1
1%
|
| United Kingdom |
8
8%
|
| Italy |
17
17%
|
| France |
10
10%
|
| United States |
53
53%
|
Outcome Measures
| Title | Composite Safety and Effectiveness Endpoint That is Based on the Percentage of Subjects Who Experienced (a) Access and/or Deployment Failures; and/or (b) Major Device Effect (MDE) Within 30 Days Post Index Procedure |
|---|---|
| Description | MDEs include: device-related secondary procedures, device-related mortality, conversion to open surgery, thoracic aortic aneurysm rupture. Access failure: Inability to insert device due to mechanical failure or anatomic exclusions of the femoral or iliac arteries. Deployment failure: Deployment failure due to subject anatomy or mechanical failure. Specifically, deployment of the stent graft from the delivery system. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the primary endpoint global cohort of 87 subjects. The poolability on the primary endpoint between US and OUS data were assessed using Fisher's exact test. |
| Time Frame | 30 Days |
Outcome Measure Data
| Analysis Population Description |
|---|
| The 30-day primary endpoint was evaluated for Premarket Approval (PMA) when 87 subjects completed 30 day follow-up. |
| Arm/Group Title | Endovascular Repair |
|---|---|
| Arm/Group Description | Valiant Evo Thoracic Stent Graft System: Procedure: thoracic endovascular aneurysm repair (TEVAR). Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the primary endpoint global cohort of 87 subjects (52 US, 35 OUS). |
| Measure Participants | 87 |
| Count of Participants [Participants] |
2
2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Endovascular Repair |
|---|---|---|
| Comments | The primary study endpoint, major device effect at 30 days, is a dichotomous study outcome; hence, an exact method based on the binomial distribution was used for the hypothesis testing. The primary study endpoint was tested against a performance goal of 16%: H0: p ≥ 16% vs. Ha: p <16%, where p denotes the true event rate of primary study endpoint in the target population. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Exact binomial test | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Event Rate |
| Estimated Value | 0.023 | |
| Confidence Interval |
(1-Sided) 97.5% to 0.081 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Safety and Effectiveness Outcome |
|---|---|
| Description | Safety and Effectiveness outcome measures between 0-30 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 Outside US [OUS]). Measures include: peri-operative mortality, adverse events (AE), major adverse events (MAE), serious adverse events (SAE), secondary procedures, loss of stent graft patency, and endoleaks. |
| Time Frame | 30 Days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 OUS). |
| Arm/Group Title | Endovascular Repair |
|---|---|
| Arm/Group Description | Subjects who were appropriate candidates for endovascular repair of Descending Thoracic Aortic Aneurysm and who met the inclusion and exclusion criteria. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 87 subjects (53 US, 47 OUS). |
| Measure Participants | 100 |
| Peri-Operative Mortality |
2
2%
|
| Adverse Events (AE) |
72
72%
|
| Major Adverse Events (MAE) |
29
29%
|
| Serious Adverse Events (SAE) |
32
32%
|
| Secondary Procedures |
2
2%
|
| Loss of Stent Graft Patency |
0
0%
|
| Endoleaks |
4
4%
|
| Title | Safety and Effectiveness Outcome |
|---|---|
| Description | Safety outcome measures between 0-183 days and Effectiveness outcome measures between 31-183 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort. Safety measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE) and secondary procedures. Effectiveness measures include loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month. |
| Time Frame | 6 Month |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International Trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 Outside US). Note that 6-month follow up is not mandatory for subjects enrolled under the Valiant Evo International protocol, resulting in fewer subjects analyzed at 6 months. |
| Arm/Group Title | Endovascular Repair |
|---|---|
| Arm/Group Description | Subjects who were appropriate candidates for endovascular repair of Descending Thoracic Aortic Aneurysms (DTAA) and who met the inclusion and exclusion criteria. |
| Measure Participants | 100 |
| All-Cause Mortality (ACM) |
6
6%
|
| Aneurysm-Related Mortality (ARM) |
3
3%
|
| Major Device Effects (MDE) |
2
2%
|
| Adverse Events (AE) |
80
80%
|
| Major Adverse Events (MAE) |
39
39%
|
| Serious Adverse Events (SAE) |
50
50%
|
| Secondary Procedures |
4
4%
|
| Loss of Stent Graft Patency |
0
0%
|
| Endoleaks |
3
3%
|
| Stent Graft Migration |
0
0%
|
| Aneurysm Expansion >5 mm relative to 1-Month |
1
1%
|
| Title | Safety and Effectiveness Outcome |
|---|---|
| Description | Safety outcome measures between 0-365 days and Effectiveness outcome measures between 184-365 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort. Safety measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE) and secondary procedures. Effectiveness measures include loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month. |
| Time Frame | 12 Month |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 OUS). |
| Arm/Group Title | Endovascular Repair |
|---|---|
| Arm/Group Description | Subjects who were appropriate candidates for endovascular repair of Descending Thoracic Aortic Aneurysm and who met the inclusion and exclusion criteria. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 OUS). |
| Measure Participants | 100 |
| All-Cause Mortality (ACM) |
10
10%
|
| Aneurysm-Related Mortality (ARM) |
3
3%
|
| Major Device Effects (MDE) |
4
4%
|
| Adverse Events (AE) |
82
82%
|
| Major Adverse Events (MAE) |
44
44%
|
| Serious Adverse Events (SAE) |
55
55%
|
| Secondary Procedures |
5
5%
|
| Loss of Stent Graft Patency |
0
0%
|
| Endoleaks |
5
5%
|
| Stent Graft Migration |
0
0%
|
| Aneurysm Expansion >5 mm relative to 1-Month |
4
4%
|
| Title | Safety and Effectiveness Outcome |
|---|---|
| Description | Safety outcome measures between 0-730 days and Effectiveness outcome measures between 366-730 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort. Safety measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE) and secondary procedures. Effectiveness measures include loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month. |
| Time Frame | 24 Month |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects who were appropriate candidates for endovascular repair of Descending Thoracic Aortic Aneurysm and who met the inclusion and exclusion criteria. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 OUS). |
| Arm/Group Title | Endovascular Repair |
|---|---|
| Arm/Group Description | Subjects who were appropriate candidates for endovascular repair of Descending Thoracic Aortic Aneurysm and who met the inclusion and exclusion criteria. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 OUS). |
| Measure Participants | 100 |
| All-Cause Mortality (ACM) |
13
13%
|
| Aneurysm-Related Mortality (ARM) |
3
3%
|
| Major Device Effects (MDE) |
5
5%
|
| Adverse Event (AE) |
85
85%
|
| Major Adverse Event (MAE) |
49
49%
|
| Serious Adverse Event (SAE) |
61
61%
|
| Secondary Procedures |
6
6%
|
| Loss of Stent Graft Patency |
0
0%
|
| Endoleaks |
2
2%
|
| Stent Graft Migration |
0
0%
|
| Aneurysm Expansion >5 mm relative to 1-Month |
4
4%
|
| Title | Safety and Effectiveness Outcome |
|---|---|
| Description | Safety outcome measures between 0-1095 days and Effectiveness outcome measures between 731-1095 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort. Safety measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE) and secondary procedures. Effectiveness measures include loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month. |
| Time Frame | 36 Month |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects who were appropriate candidates for endovascular repair of Descending Thoracic Aortic Aneurysm and who met the inclusion and exclusion criteria. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 OUS). |
| Arm/Group Title | Endovascular Repair |
|---|---|
| Arm/Group Description | Subjects who were appropriate candidates for endovascular repair of Descending Thoracic Aortic Aneurysm and who met the inclusion and exclusion criteria. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 OUS). |
| Measure Participants | 100 |
| All-Cause Mortality |
14
14%
|
| Aneurysm-Related Mortality |
3
3%
|
| Major Device Effects (MDE) |
6
6%
|
| Adverse Event (AE) |
88
88%
|
| Major Adverse Event (MAE) |
51
51%
|
| Serious Adverse Event (SAE) |
64
64%
|
| Secondary Procedures |
6
6%
|
| Loss of Stent Graft Patency |
0
0%
|
| Endoleaks |
3
3%
|
| Stent Graft Migration |
1
1%
|
| Aneurysm Expansion >5mm relative to 1-Month |
4
4%
|
| Title | Safety and Effectiveness Outcome |
|---|---|
| Description | Safety and effectiveness outcome measure between implant procedure and 48 months. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort. Measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE), secondary procedures, loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month. |
| Time Frame | 48 month |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Safety and Effectiveness Outcome |
|---|---|
| Description | Safety and Effectiveness outcome measures between implant procedure and 60 months. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort. Measures include: aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE), secondary procedures, loss of stent graft patency, stent graft migration compared to 1 month imaging, aneurysm expansion greater than 5 mm compared to 1 month imaging, and endoleaks. |
| Time Frame | 60 Month |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
Adverse Events
| Time Frame | Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months and 36 Months | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||
| Arm/Group Title | Endovascular Repair 30-Day Secondary Endpoint | Endovascular Repair 6-Month Secondary Endpoint | Endovascular Repair 12-Month Secondary Endpoint | Endovascular Repair 24-Month Secondary Endpoint | Endovascular Repair 36-Month Secondary | |||||
| Arm/Group Description | Subjects treated with the Valiant Evo Thoracic Stent Graft, who experienced all-cause mortality, or one or more serious adverse event within 0-30 days Procedure: thoracic endovascular aneurysm repair (TEVAR) For All-Cause Mortality, the number of participants at risk includes all enrolled subjects who either had an event within the 30-Day time period or were followed for at least 1 day. For Adverse Events, the 30-Day time period for reporting is 0-30 days. The number of participants at risk includes the number of subjects at risk at the beginning of the 30-Day time interval. | Subjects treated with the Valiant Evo Thoracic Stent Graft, who experienced all-cause mortality within 0-183 days, or one or more serious adverse event within 31-183 days Procedure: thoracic endovascular aneurysm repair (TEVAR) For All-Cause Mortality, the number of participants at risk includes all enrolled subjects who either had an event within the 6-Month time period or were followed for at least 91 days. For Adverse Events, the 6-Month time period for reporting is 31-183 days. The number of participants at risk includes the number of subjects at risk at the beginning of the 6-Month time interval. | Subjects treated with the Valiant Evo Thoracic Stent Graft, who experienced all-cause mortality within 0-365 days, or one or more serious adverse event within 184-365 days Procedure: thoracic endovascular aneurysm repair (TEVAR) For All-Cause Mortality, the number of participants at risk includes all enrolled subjects who either had an event within the 12-Month time period or were followed for at least 305 days. For Adverse Events, the 12-Month time period for reporting is 184-365 days. The number of participants at risk includes the number of subjects at risk at the beginning of the 12-Month time interval. | Subjects treated with the Valiant Evo Thoracic Stent Graft, who experienced all-cause mortality within 0-730 days, or one or more serious adverse event within 366-730 days Procedure: thoracic endovascular aneurysm repair (TEVAR) For All-Cause Mortality, the number of participants at risk includes all enrolled subjects who either had an event within the 24-Month time period or were followed for at least 549 days. For Adverse Events, the 24-Month time period for reporting is 366-730 days. The number of participants at risk includes the number of subjects at risk at the beginning of the 24-Month time interval. | Subjects treated with the Valiant Evo Thoracic Stent Graft, who experienced all-cause mortality within 0-1095 days, or one or more serious adverse event within 731-1095 days Procedure: thoracic endovascular aneurysm repair (TEVAR) For All-Cause Mortality, the number of participants at risk includes all enrolled subjects who either had an event within the 36-Month time period or were followed for at least 914 days. For Adverse Events, the 36-Month time period for reporting is 731-1095 days. The number of participants at risk includes the number of subjects at risk at the beginning of the 36-Month time interval. | |||||
All Cause Mortality |
||||||||||
| Endovascular Repair 30-Day Secondary Endpoint | Endovascular Repair 6-Month Secondary Endpoint | Endovascular Repair 12-Month Secondary Endpoint | Endovascular Repair 24-Month Secondary Endpoint | Endovascular Repair 36-Month Secondary | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/100 (2%) | 6/99 (6.1%) | 10/97 (10.3%) | 13/80 (16.3%) | 14/78 (17.9%) | |||||
Serious Adverse Events |
||||||||||
| Endovascular Repair 30-Day Secondary Endpoint | Endovascular Repair 6-Month Secondary Endpoint | Endovascular Repair 12-Month Secondary Endpoint | Endovascular Repair 24-Month Secondary Endpoint | Endovascular Repair 36-Month Secondary | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 32/100 (32%) | 27/98 (27.6%) | 22/91 (24.2%) | 16/83 (19.3%) | 12/64 (18.8%) | |||||
| Blood and lymphatic system disorders | ||||||||||
| Anaemia | 0/100 (0%) | 2/98 (2%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Anaemia Of Chronic Disease | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Blood Loss Anaemia | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Neutrophilia | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Splenic lesion | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Cardiac disorders | ||||||||||
| Acute Myocardial Infarction | 1/100 (1%) | 0/98 (0%) | 1/91 (1.1%) | 2/83 (2.4%) | 0/64 (0%) | |||||
| Angina Unstable | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 1/64 (1.6%) | |||||
| Atrial Fibrillation | 3/100 (3%) | 2/98 (2%) | 1/91 (1.1%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Atrioventricular Block | 1/100 (1%) | 0/98 (0%) | 1/91 (1.1%) | 0/83 (0%) | 0/64 (0%) | |||||
| Cardiac Failure | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Cardiac Failure Congestive | 2/100 (2%) | 1/98 (1%) | 2/91 (2.2%) | 3/83 (3.6%) | 1/64 (1.6%) | |||||
| Coronary Artery Dissection | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Coronary Artery Occlusion | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Ischaemic Cardiomyopathy | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Left Ventricular Failure | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Sinus Node Dysfunction | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Tachycardia | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Ventricular Fibrillation | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Ventricular Tachycardia | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Eye disorders | ||||||||||
| Retinal Detachment | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 1/64 (1.6%) | |||||
| Gastrointestinal disorders | ||||||||||
| Abdominal Hernia | 0/100 (0%) | 0/98 (0%) | 1/91 (1.1%) | 0/83 (0%) | 0/64 (0%) | |||||
| Abdominal Pain | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Anal Incontinence | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Change of Bowel Habit | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Colitis | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Colitis Ischaemic | 0/100 (0%) | 0/98 (0%) | 1/91 (1.1%) | 0/83 (0%) | 0/64 (0%) | |||||
| Dysphagia | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 1/64 (1.6%) | |||||
| Enteritis | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 1/64 (1.6%) | |||||
| Fistula of Small Intestine | 0/100 (0%) | 0/98 (0%) | 1/91 (1.1%) | 0/83 (0%) | 0/64 (0%) | |||||
| Gastritis | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Gastrointestinal Haemorrhage | 1/100 (1%) | 1/98 (1%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Haemorrhoidal haemorrhage | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 1/64 (1.6%) | |||||
| Ileus | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Inguinal Hernia | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 1/64 (1.6%) | |||||
| Intestinal Strangulation | 0/100 (0%) | 0/98 (0%) | 1/91 (1.1%) | 0/83 (0%) | 0/64 (0%) | |||||
| Pancreatitis Acute | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Small Intestine Obstruction | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 1/64 (1.6%) | |||||
| General disorders | ||||||||||
| Death | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Pyrexia | 2/100 (2%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Stent-Graft Endoleak | 1/100 (1%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 1/64 (1.6%) | |||||
| Vascular Stent Thrombosis | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 1/64 (1.6%) | |||||
| Hepatobiliary disorders | ||||||||||
| Cholangitis | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Cholecystitis Acute | 1/100 (1%) | 1/98 (1%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Immune system disorders | ||||||||||
| Anaphylactic Shock | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Infections and infestations | ||||||||||
| Bacterial Sepsis | 0/100 (0%) | 0/98 (0%) | 1/91 (1.1%) | 0/83 (0%) | 0/64 (0%) | |||||
| Bronchitis | 0/100 (0%) | 0/98 (0%) | 1/91 (1.1%) | 0/83 (0%) | 0/64 (0%) | |||||
| Localised Infection | 0/100 (0%) | 0/98 (0%) | 1/91 (1.1%) | 0/83 (0%) | 0/64 (0%) | |||||
| Pneumonia | 0/100 (0%) | 3/98 (3.1%) | 5/91 (5.5%) | 2/83 (2.4%) | 0/64 (0%) | |||||
| Pulmonary Sepsis | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Sepsis | 2/100 (2%) | 2/98 (2%) | 2/91 (2.2%) | 0/83 (0%) | 0/64 (0%) | |||||
| Septic Shock | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Urinary Tract Infection | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 1/64 (1.6%) | |||||
| Urinary Tract Infection Bacterial | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Urinary Tract Infection Staphylococcal | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Urosepsis | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Vascular Device Infection | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Injury, poisoning and procedural complications | ||||||||||
| Cervical Vertebral Fracture | 0/100 (0%) | 0/98 (0%) | 1/91 (1.1%) | 0/83 (0%) | 0/64 (0%) | |||||
| Facial Bones Fracture | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Femoral Neck Fracture | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Hand Fracture | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Hip Fracture | 0/100 (0%) | 0/98 (0%) | 1/91 (1.1%) | 0/83 (0%) | 0/64 (0%) | |||||
| Incomplete Spinal Fusion | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 1/64 (1.6%) | |||||
| Overdose | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Post Lumbar Puncture Syndrome | 2/100 (2%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Postoperative Delirium | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Respiratory Tract Procedural Complication | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Spinal Compression Fracture | 1/100 (1%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Spinal Fracture | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Tracheal Haemorrhage | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Vascular Pseudoaneurysm | 1/100 (1%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Wound Dehiscence | 0/100 (0%) | 0/98 (0%) | 1/91 (1.1%) | 0/83 (0%) | 0/64 (0%) | |||||
| Investigations | ||||||||||
| Blood Creatinine Increased | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Weight Decreased | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Metabolism and nutrition disorders | ||||||||||
| Failure to Thrive | 0/100 (0%) | 0/98 (0%) | 1/91 (1.1%) | 0/83 (0%) | 0/64 (0%) | |||||
| Fluid Overload | 0/100 (0%) | 0/98 (0%) | 1/91 (1.1%) | 0/83 (0%) | 0/64 (0%) | |||||
| Hypokalaemia | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Hyponatraemia | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Malnutrition | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Vitamin D Deficiency | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Musculoskeletal and connective tissue disorders | ||||||||||
| Arthritis | 0/100 (0%) | 0/98 (0%) | 1/91 (1.1%) | 0/83 (0%) | 0/64 (0%) | |||||
| Muscular Weakness | 1/100 (1%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Pain in Extremity | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Pseudarthrosis | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||
| Adenocarcinoma Pancreas | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Bladder Cancer Recurrent | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Intraductal Papillary Mucinous Neoplasm | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Lung Squamous Cell Carcinoma Stage Iii | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Metastatic Neoplasm | 0/100 (0%) | 0/98 (0%) | 1/91 (1.1%) | 0/83 (0%) | 0/64 (0%) | |||||
| Myeloproliferative Neoplasm | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Oesophageal Neoplasm | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Nervous system disorders | ||||||||||
| Cerebellar Infarction | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 2/83 (2.4%) | 0/64 (0%) | |||||
| Cerebral Infarction | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Cerebrovascular Accident | 2/100 (2%) | 0/98 (0%) | 1/91 (1.1%) | 0/83 (0%) | 0/64 (0%) | |||||
| Dementia with Lewy Bodies | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Embolic Stroke | 2/100 (2%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Guillain-Barre Syndrome | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 1/64 (1.6%) | |||||
| Hypoaesthesia | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Ischaemic Stroke | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Lacunar Stroke | 0/100 (0%) | 0/98 (0%) | 1/91 (1.1%) | 0/83 (0%) | 0/64 (0%) | |||||
| Metabolic Encephalopathy | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Paraplegia | 0/100 (0%) | 0/98 (0%) | 1/91 (1.1%) | 0/83 (0%) | 0/64 (0%) | |||||
| Parkinson's Disease | 0/100 (0%) | 0/98 (0%) | 1/91 (1.1%) | 0/83 (0%) | 0/64 (0%) | |||||
| Spinal Cord Ischaemia | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Syncope | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Transient Ischaemic Attack | 0/100 (0%) | 1/98 (1%) | 1/91 (1.1%) | 0/83 (0%) | 0/64 (0%) | |||||
| Vascular Encephalopathy | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 1/64 (1.6%) | |||||
| Product Issues | ||||||||||
| Device Breakage | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Psychiatric disorders | ||||||||||
| Delirium Tremens | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Depression | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 1/64 (1.6%) | |||||
| Mental Status Changes | 1/100 (1%) | 0/98 (0%) | 1/91 (1.1%) | 0/83 (0%) | 0/64 (0%) | |||||
| Suicidal Ideation | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Renal and urinary disorders | ||||||||||
| Acute Kidney Injury | 0/100 (0%) | 2/98 (2%) | 2/91 (2.2%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| End Stage Renal Disease | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Nephrolithiasis | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 1/64 (1.6%) | |||||
| Renal Tubular Necrosis | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Ureteric Obstruction | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Urinary Bladder Polyp | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Urinary Incontinence | 1/100 (1%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Acute Respiratory Failure | 1/100 (1%) | 0/98 (0%) | 1/91 (1.1%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Atelectasis | 2/100 (2%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Chronic Obstructive Pulmonary Disease | 1/100 (1%) | 3/98 (3.1%) | 1/91 (1.1%) | 2/83 (2.4%) | 1/64 (1.6%) | |||||
| Chylothorax | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Dyspnoea | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Hypoxia | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Pleurisy | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Pulmonary Congestion | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Pulmonary Embolism | 1/100 (1%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Pulmonary Fibrosis | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Pulmonary Hypertension | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Pulmonary Mass | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Respiratory Distress | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Respiratory Failure | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 2/64 (3.1%) | |||||
| Vascular disorders | ||||||||||
| Aortic Aneurysm | 0/100 (0%) | 2/98 (2%) | 1/91 (1.1%) | 2/83 (2.4%) | 0/64 (0%) | |||||
| Aortic Dissection | 2/100 (2%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Aortic Rupture | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Atheroembolism | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Haemorrhage | 0/100 (0%) | 0/98 (0%) | 1/91 (1.1%) | 0/83 (0%) | 0/64 (0%) | |||||
| Hypertension | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Hypertensive Urgency | 1/100 (1%) | 0/98 (0%) | 1/91 (1.1%) | 0/83 (0%) | 0/64 (0%) | |||||
| Iliac Artery Stenosis | 0/100 (0%) | 0/98 (0%) | 1/91 (1.1%) | 0/83 (0%) | 0/64 (0%) | |||||
| Orthostatic Hypotension | 0/100 (0%) | 2/98 (2%) | 1/91 (1.1%) | 0/83 (0%) | 0/64 (0%) | |||||
| Peripheral Arterial Occlusive Disease | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 1/64 (1.6%) | |||||
| Peripheral Artery Occlusion | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Peripheral Artery Thrombosis | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Peripheral Ischaemia | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Thrombophlebitis | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
Other (Not Including Serious) Adverse Events |
||||||||||
| Endovascular Repair 30-Day Secondary Endpoint | Endovascular Repair 6-Month Secondary Endpoint | Endovascular Repair 12-Month Secondary Endpoint | Endovascular Repair 24-Month Secondary Endpoint | Endovascular Repair 36-Month Secondary | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 62/100 (62%) | 31/98 (31.6%) | 20/91 (22%) | 19/83 (22.9%) | 13/64 (20.3%) | |||||
| Blood and lymphatic system disorders | ||||||||||
| Anaemia | 8/100 (8%) | 2/98 (2%) | 1/91 (1.1%) | 0/83 (0%) | 0/64 (0%) | |||||
| Iron Deficiency Anaemia | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Leukocytosis | 5/100 (5%) | 2/98 (2%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Thrombocytopenia | 2/100 (2%) | 2/98 (2%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Cardiac disorders | ||||||||||
| Acute Myocardial Infarction | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Angina Pectoris | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Aortic Valve Stenosis | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Atrial Fibrillation | 2/100 (2%) | 1/98 (1%) | 1/91 (1.1%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Atrial Flutter | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Atrial Tachycardia | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Atrioventricular Block First Degree | 2/100 (2%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Bradycardia | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Cardiac Failure Congestive | 0/100 (0%) | 3/98 (3.1%) | 2/91 (2.2%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Coronary Artery Disease | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 1/64 (1.6%) | |||||
| Hypertensive Cardiomyopathy | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Palpitations | 0/100 (0%) | 0/98 (0%) | 1/91 (1.1%) | 0/83 (0%) | 1/64 (1.6%) | |||||
| Pericardial Effusion | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Sinus Bradycardia | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Sinus Tachycardia | 2/100 (2%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Supraventricular Tachycardia | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Torsade De Pointes | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Ventricular Extrasystoles | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Ventricular Tachycardia | 0/100 (0%) | 0/98 (0%) | 1/91 (1.1%) | 0/83 (0%) | 0/64 (0%) | |||||
| Congenital, familial and genetic disorders | ||||||||||
| Congenital Hypercoagulation | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Gastrointestinal Arteriovenous Malformation | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Loeys-Dietz Syndrome | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Ear and labyrinth disorders | ||||||||||
| Vertigo | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Gastrointestinal disorders | ||||||||||
| Abdominal Pain Lower | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Abdominal Pain Upper | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Abdominal Tenderness | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Abdominal Wall Haematoma | 0/100 (0%) | 0/98 (0%) | 1/91 (1.1%) | 0/83 (0%) | 0/64 (0%) | |||||
| Colitis Ischaemic | 0/100 (0%) | 0/98 (0%) | 1/91 (1.1%) | 0/83 (0%) | 0/64 (0%) | |||||
| Constipation | 3/100 (3%) | 0/98 (0%) | 1/91 (1.1%) | 0/83 (0%) | 0/64 (0%) | |||||
| Diverticulum | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Dysphagia | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Gastrointestinal Angiectasia | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Gastrointestinal Haemorrhage | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Haematochezia | 0/100 (0%) | 1/98 (1%) | 1/91 (1.1%) | 0/83 (0%) | 0/64 (0%) | |||||
| Hiatus Hernia | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Ileus | 0/100 (0%) | 0/98 (0%) | 1/91 (1.1%) | 0/83 (0%) | 0/64 (0%) | |||||
| Presbyoesophagus | 0/100 (0%) | 0/98 (0%) | 1/91 (1.1%) | 0/83 (0%) | 0/64 (0%) | |||||
| General disorders | ||||||||||
| Asthenia | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Chest Pain | 2/100 (2%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Facial Pain | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Fatigue | 1/100 (1%) | 0/98 (0%) | 1/91 (1.1%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Generalized Oedema | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Influenza Like Illness | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 1/64 (1.6%) | |||||
| Non-Cardiac Chest Pain | 2/100 (2%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Oedema | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Oedema Peripheral | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Peripheral Swelling | 1/100 (1%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Puncture Site Haemorrhage | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Pyrexia | 6/100 (6%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Stent-Graft Endoleak | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Infections and infestations | ||||||||||
| Cellulitis | 0/100 (0%) | 0/98 (0%) | 1/91 (1.1%) | 0/83 (0%) | 0/64 (0%) | |||||
| Central Nervous System Infection | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Clostridium Difficile Colitis | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Epididymitis | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 1/64 (1.6%) | |||||
| Gastroenteritis | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Groin Abscess | 0/100 (0%) | 0/98 (0%) | 1/91 (1.1%) | 0/83 (0%) | 0/64 (0%) | |||||
| Influenza | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Oesophageal Candidiasis | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Pneumonia | 1/100 (1%) | 3/98 (3.1%) | 1/91 (1.1%) | 0/83 (0%) | 1/64 (1.6%) | |||||
| Pneumonia Staphylococcal | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Post Procedural Sepsis | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Skin Infection | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Upper Respiratory Tract Infection | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 1/83 (1.2%) | 1/64 (1.6%) | |||||
| Urinary Tract Infection | 7/100 (7%) | 3/98 (3.1%) | 1/91 (1.1%) | 3/83 (3.6%) | 0/64 (0%) | |||||
| Injury, poisoning and procedural complications | ||||||||||
| Anaemia Postoperative | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Aortic Injury | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Bone Contusion | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 1/64 (1.6%) | |||||
| Cervical Vertebral Fracture | 0/100 (0%) | 0/98 (0%) | 1/91 (1.1%) | 0/83 (0%) | 0/64 (0%) | |||||
| Corneal Abrasion | 0/100 (0%) | 0/98 (0%) | 1/91 (1.1%) | 0/83 (0%) | 0/64 (0%) | |||||
| Fall | 2/100 (2%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Incision Site Erythema | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Incision Site Pain | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Joint Dislocation | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Ligament Rupture | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 1/64 (1.6%) | |||||
| Post Procedural Fever | 3/100 (3%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Postimplantation Syndrome | 2/100 (2%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Postoperative Delirium | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Postoperative Respiratory Failure | 3/100 (3%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Procedural Haemorrhage | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Procedural Hypotension | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Procedural Site Reaction | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Radius Fracture | 0/100 (0%) | 0/98 (0%) | 1/91 (1.1%) | 0/83 (0%) | 0/64 (0%) | |||||
| Seroma | 1/100 (1%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Spinal Compression Fracture | 0/100 (0%) | 0/98 (0%) | 1/91 (1.1%) | 0/83 (0%) | 0/64 (0%) | |||||
| Sternal Fracture | 0/100 (0%) | 0/98 (0%) | 1/91 (1.1%) | 0/83 (0%) | 0/64 (0%) | |||||
| Traumatic Haematoma | 0/100 (0%) | 0/98 (0%) | 1/91 (1.1%) | 0/83 (0%) | 0/64 (0%) | |||||
| Vascular Access Site Complication | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Vascular Access Site Haematoma | 2/100 (2%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Vascular Access Site Haemorrhage | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Vascular Pseudoaneurysm | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Wound Dehiscence | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Investigations | ||||||||||
| Blood Creatine Phosphokinase Increased | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Blood Magnesium Decreased | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Blood Pressure Increased | 0/100 (0%) | 0/98 (0%) | 1/91 (1.1%) | 0/83 (0%) | 0/64 (0%) | |||||
| Oxygen Saturation Decreased | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Transaminases Increased | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Troponin I Increased | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Troponin Increased | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Urine Output Decreased | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Metabolism and nutrition disorders | ||||||||||
| Electrolyte Imbalance | 2/100 (2%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Fluid Overload | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Gout | 1/100 (1%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Hyperkalaemia | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Hyperlipasaemia | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Hypernatraemia | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Hypokalaemia | 2/100 (2%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Hyponatraemia | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Hypophosphataemia | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Malnutrition | 0/100 (0%) | 0/98 (0%) | 1/91 (1.1%) | 0/83 (0%) | 0/64 (0%) | |||||
| Musculoskeletal and connective tissue disorders | ||||||||||
| Arthralgia | 2/100 (2%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Back Pain | 5/100 (5%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Costochondritis | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Fibromyalgia | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Haemarthrosis | 0/100 (0%) | 0/98 (0%) | 1/91 (1.1%) | 0/83 (0%) | 0/64 (0%) | |||||
| Joint Swelling | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Muscular Weakness | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Musculoskeletal Chest Pain | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||
| Basal Cell Carcinoma | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 2/83 (2.4%) | 0/64 (0%) | |||||
| Bowen's Disease | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Lung Neoplasm Malignant | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Prostate Cancer | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Renal Neoplasm | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Nervous system disorders | ||||||||||
| Asterixis | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Carotid Artery Dissection | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Carotid Artery Stenosis | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Dizziness | 2/100 (2%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Encephalopathy | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Headache | 3/100 (3%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Hypoaesthesia | 2/100 (2%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Morton's Neuralgia | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Neuralgia | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Neurological Decompensation | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Paraesthesia | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Parkinson's Disease | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Presyncope | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Radial Nerve Palsy | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Spinal Cord Infarction | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Spinal Subarachnoid Haemorrhage | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Psychiatric disorders | ||||||||||
| Anxiety | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Confusional State | 2/100 (2%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Delirium | 3/100 (3%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Depression | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Mental Status Changes | 2/100 (2%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Renal and urinary disorders | ||||||||||
| Acute Kidney Injury | 3/100 (3%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Chronic Kidney Disease | 0/100 (0%) | 2/98 (2%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Cystitis Haemorrhagic | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Focal Segmental Glomerulosclerosis | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 1/64 (1.6%) | |||||
| Haematuria | 2/100 (2%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Renal Failure | 2/100 (2%) | 0/98 (0%) | 1/91 (1.1%) | 0/83 (0%) | 0/64 (0%) | |||||
| Renal Ischaemia | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Renal Mass | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Urinary Incontinence | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Urinary Retention | 3/100 (3%) | 0/98 (0%) | 1/91 (1.1%) | 0/83 (0%) | 0/64 (0%) | |||||
| Reproductive system and breast disorders | ||||||||||
| Prostatomegaly | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Acute Respiratory Failure | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Atelectasis | 5/100 (5%) | 0/98 (0%) | 0/91 (0%) | 2/83 (2.4%) | 0/64 (0%) | |||||
| Chronic Obstructive Pulmonary Disease | 1/100 (1%) | 2/98 (2%) | 0/91 (0%) | 0/83 (0%) | 1/64 (1.6%) | |||||
| Cough | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Diaphragmatic Paralysis | 0/100 (0%) | 0/98 (0%) | 1/91 (1.1%) | 0/83 (0%) | 0/64 (0%) | |||||
| Dysphonia | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Dyspnoea | 2/100 (2%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Dyspnoea Exertional | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Epistaxis | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Hypercapnia | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Lung Consolidation | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Lung Infiltration | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Lung Opacity | 0/100 (0%) | 0/98 (0%) | 1/91 (1.1%) | 0/83 (0%) | 0/64 (0%) | |||||
| Painful Respiration | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Pleural Effusion | 12/100 (12%) | 1/98 (1%) | 1/91 (1.1%) | 2/83 (2.4%) | 0/64 (0%) | |||||
| Pleurisy | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Pleuritic Pain | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Pulmonary Mass | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 1/64 (1.6%) | |||||
| Pulmonary Oedema | 2/100 (2%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 1/64 (1.6%) | |||||
| Respiratory Acidosis | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Skin and subcutaneous tissue disorders | ||||||||||
| Drug Eruption | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Keloid Scar | 0/100 (0%) | 0/98 (0%) | 1/91 (1.1%) | 0/83 (0%) | 0/64 (0%) | |||||
| Petechiae | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Pruritus | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Rash | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Skin Reaction | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 1/64 (1.6%) | |||||
| Vascular disorders | ||||||||||
| Aortic Aneurysm | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 2/83 (2.4%) | 1/64 (1.6%) | |||||
| Aortic Dissection | 0/100 (0%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Deep Vein Thrombosis | 0/100 (0%) | 2/98 (2%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Haematoma | 2/100 (2%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Hypertension | 7/100 (7%) | 4/98 (4.1%) | 0/91 (0%) | 0/83 (0%) | 1/64 (1.6%) | |||||
| Hypotension | 4/100 (4%) | 1/98 (1%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Jugular Vein Thrombosis | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Peripheral Arterial Occlusive Disease | 0/100 (0%) | 2/98 (2%) | 0/91 (0%) | 2/83 (2.4%) | 0/64 (0%) | |||||
| Peripheral Embolism | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 0/64 (0%) | |||||
| Peripheral Ischaemia | 1/100 (1%) | 0/98 (0%) | 0/91 (0%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Subclavian Artery Stenosis | 1/100 (1%) | 0/98 (0%) | 1/91 (1.1%) | 1/83 (1.2%) | 0/64 (0%) | |||||
| Subclavian Artery Thrombosis | 0/100 (0%) | 0/98 (0%) | 0/91 (0%) | 0/83 (0%) | 1/64 (1.6%) | |||||
Limitations/Caveats
Clinical evidence collected as part of the Valiant Evo US Clinical Trial (NCT02652949) and the Valiant Evo International Clinical Trial (NCT02625324) are combined to support commercial marketing approvals.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Medtronic owns the data of this clinical study, a single investigation site may access and use the data provided by itself for scientific publications following prior approval by Medtronic. Pooling data from several investigation sites for publication purposes, national projects and international projects all require prior approval from Medtronic.
Results Point of Contact
| Name/Title | Katrin Dias - Clinical Study Manager |
|---|---|
| Organization | Medtronic |
| Phone | 707-525-0111 |
| katrin.a.dias@medtronic.com |
Responsible Party:
Medtronic Cardiovascular
ClinicalTrials.gov Identifier:
NCT02625324
Other Study ID Numbers:
- 10219493DOC
First Posted:
Dec 9, 2015
Last Update Posted:
Jun 28, 2022
Last Verified:
Jun 1, 2022