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This study was designed to study safety and effectiveness of the Valiant Thoracic Stent Graft to treat thoracic aortic aneurysms.
The aorta is a large blood vessel that carries blood away from the heart to the organs in the rest of the body. An aneurysm is a weakening in the artery wall that will become a bulge in the aorta. If left untreated, this bulge may continue to grow larger and may rupture (break open) with fatal consequences. In this research study we are investigating a device that can be placed in the aorta to exclude the weakened part of the artery wall and restore blood flow. Information will be collected on the performance of the device for 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Valiant Thoracic Stent Graft System | Experimental | 160 subjects were enrolled into the study, including 157 subjects treated with the study device and three subjects classified as intent-to-treat who did not receive the study device. There were no other arms for this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valiant Thoracic Stent Graft System | Device | Surgical procedure in which a device is implanted inside the aorta, isolating the diseased area (aneurysm). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants That Did NOT Experience Aneurysm-Related Mortality (Post-market Primary Endpoint) | Evaluation of the ARM-free rate in subjects implanted with the Valiant Thoracic Stent Graft five years post-implantation by comparing it to a pre-defined performance goal (PG) based on an analysis of ARM-free rates from TEVAR data and on results from the VALOR (Talent Thoracic Endoluminal Stent Graft, IDE G980116) clinical study. | 0 through 1825 days post treatment |
| Percentage of Participants With Successful Aneurysm Treatment (Primary Effectiveness Endpoint) | Percentage of subjects with absence of both: a) aneurysm growth of more than 5 mm at the 12-month visit relative to the 1-month visit; and b) secondary procedure due to type I or III endoleak performed or recommended at or before the 12-month visit. Success means a subject experienced neither a nor b. Type I: endoleak in continuity with the proximal anchoring site(proximal endoleak) or the distal anchoring site(distal endoleak)of the device. Type III: endoleak is present in the mid-graft region due to defect of fabric or between the segments of the modular graft (junctional endoleak). | At 12-month post procedure |
| Percentage of Participants Who Died (Primary Safety Endpoint: All-Cause Mortality) > > | The percentage of participants who died within 12-months of the initial procedure, whether or not the cause of death was related to the study device, procedure, or condition treated. > > Note: All-cause mortality endpoint is not directly related to successful aneurysm treatment, which pertains to the absence of aneurysm growth and secondary procedure due to Type I and III endoleaks. | Within 12-months post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects That Experienced Successful Deployment and Delivery of the Stent Graft at Implant | Percentage of subjects that experienced successful deployment and delivery of the stent graft at implant. Successful deployment and delivery of the stent graft is used to measure effectiveness. | At implant |
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The following inclusion/exclusion criteria was obtained from the study protocol.
INCLUSION CRITERIA
To be eligible for enrollment, a subject must meet all of the following inclusion criteria:
Subject is between the age of 18 and 85.
Subject must be considered a candidate for elective surgical repair of the TAA (i.e., low-to-moderate risk [categories 0, 1, and 2] per the modified SVS/AAVS scoring system at the time of implant). See Appendix B: Modified SVS/AAVS Medical Co-Morbidity Grading System
If subject is female of childbearing potential, she must have a negative pregnancy test within 7 days before the implant procedure.
Subject has a DTA that is:
A fusiform aneurysm with a maximum diameter of ≥ 5 cm OR is > 2 times the diameter of the non-aneurysmal thoracic aorta;
AND/OR
Saccular aneurysm (penetrating atherosclerotic ulcer)
Subject's anatomy must meet all of the following anatomical criteria:
Thoracic aortic lesion is confirmed, at a minimum, by diagnostic contrast enhanced computerized tomography (CT) with optional 3-D reconstruction, and/or contrast enhanced Magnetic Resonance Angiogram obtained within four (4) months prior to the implant procedure.
Subject is able and willing to comply with the protocol and undergo follow-up requirements.
Subject or subject's legal representative understands and has signed an Informed Consent approved by the Sponsor and by the IRB for this study.
Subject has patent iliac or femoral arteries or can tolerate a vascular conduit that allows endovascular access to the aneurysmal site with the delivery system of the appropriate size device chosen for treatment.
EXCLUSION CRITERIA
To be eligible for enrollment, a subject cannot meet any of the following exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald Fairman, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| University of Southern California - Healthcare Consultation Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28366302 | Derived | Conrad MF, Tuchek J, Freezor R, Bavaria J, White R, Fairman R. Results of the VALOR II trial of the Medtronic Valiant Thoracic Stent Graft. J Vasc Surg. 2017 Aug;66(2):335-342. doi: 10.1016/j.jvs.2016.12.136. Epub 2017 Mar 30. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Valiant Thoracic Stent Graft System | Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| 0 to 30-day Post Treatment |
|
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|
| Percentage of Participants That Experienced Perioperative Mortality |
Percentage of subjects that experienced perioperative mortality. Perioperative morality is defined as all-cause mortality within 30 days after index procedure. |
| Within 30 days post treatment |
| Percentage of Participants That Experienced Paraplegia | Percentage of subjects that experienced paraplegia within 30 days post treatment | Within 30 days post treatment |
| Percentage of Participants That Experienced Paraparesis | Percentage of subjects that experienced paraparesis within 30 days post treatment | Within 30 days post treatment |
| Percentage of Participants That Experienced Secondary Procedures Due to Endoleak After Discharge | Percentage of subjects that experienced secondary procedures due to endoleak after discharge within 30 days post treatment | Within 30 days post treatment |
| Percentage of Participants That Experienced One or More Major Adverse Events | Percentage of subjects that experienced one or more major adverse events within 30 days post treatment, regardless of relatedness to study device | Within 30 days post treatment |
| Percentage of Participants That Experienced Aneurysm-related Mortality | Percentage of subjects that experienced aneurysm-related mortality within 12 months post treatment | Within 12 months post treatment |
| Percentage of Participants That Experience Aneurysm Rupture | Percentage of subjects that experience aneurysm rupture within 12 months post treatment | Within 12 months post treatment |
| Percentage of Participants That Experienced Conversion to Open Surgical Repair | Percentage of subjects that experienced conversion to open surgical repair within 12 months post treatment | Within 12 months post treatment |
| Percentage of Participants That Experienced Endoleak(s) | Percentage of subjects that experienced endoleak(s) of any type at 12 months | At 12 months |
| Percentage of Participants That Experienced Secondary Endovascular Procedures Due to Endoleak | Percentage of subjects that experienced secondary endovascular procedures due to endoleak between 30 days and 12 months | Between 30 days and 12 months |
| Percentage of Participants That Experienced Stent Graft Migration | Percentage of subjects that experienced stent graft migration within 12 months post treatment, as reported by the CEC. Of note, all migrations resulted from anatomical accommodation of the stent graft. All migrations were at the distal end of the stent graft, moving proximally. No endoleaks were associated to these migrations. | Within 12 months post treatment |
| Percentage of Participants That Experience Loss of Stent Graft Patency | Percentage of subjects that experience loss of stent graft patency within 12 months post treatment | Within 12 months post treatment |
| Percentage of Participants That Experienced One or More Major Adverse Events | Percentage of subjects that experienced one or more Major Adverse Events within 12 months post treatment | Within 12 months post treatment |
| Percentage of Participants That Died (All-cause Mortality) | Percentage of subjects that died (all-cause mortality) five years post implant, regardless whether or not the cause of death was related to procedure, device, or condition treated | 0 through 1825 days post treatment |
| Percentage of Participants That Experienced Aneurysm-related Mortality | Percentage of subjects that experienced aneurysm-related within five years post implant | 0 through 1825 days post treatment |
| Percentage of Participants That Experienced Aneurysm Ruptures | Percentage of subjects that experienced aneurysm ruptures within five years post implant | 0 through 1825 days post treatment |
| Percentage of Participants That Experienced Conversions to Open Surgical Repair | Percentage of subjects that experienced conversions to open surgical repair within five years post implant | 0 through 1825 days post treatment |
| Percentage of Participants That Experienced Type I Endoleaks | Percentage of subjects that experienced type I endoleaks within five years post implant | 0 through 1825 days post treatment |
| Percentage of Participants That Experienced Type III Endoleaks | Percentage of subjects that experienced type III endoleaks within five years post implant | 0 through 1825 days post treatment |
| Percentage of Participants That Experienced Type IV Endoleaks | Percentage of subjects that experienced type IV endoleaks within five years post implant | 0 through 1825 days post treatment |
| Percentage of Participants That Experienced Secondary Endovascular Procedures | Percentage of subjects that experienced secondary endovascular procedures within five years post implant | 0 through 1825 days post treatment |
| Percentage of Participants That Experienced Stent Graft Migrations (Site Reported) | Percentage of subjects that experienced stent graft migrations within five years post implant, as reported by the clinical sites | 0 through 1825 days post treatment |
| Percentage of Participants That Experienced Loss of Stent Graft Patency | Percentage of subjects that experienced loss of stent graft patency within five years post implant | 0 through 1825 days post treatment |
| Los Angeles |
| California |
| 90033 |
| United States |
| Los Angeles Biomedical Research Institute @ Harbor-UCLA Medical Center | Torrance | California | 90502 | United States |
| Hartford Hospital | Hartford | Connecticut | 06106 | United States |
| University of Florida | Gainesville | Florida | 32610 | United States |
| University of South Florida | Tampa | Florida | 33606 | United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Union Memorial | Baltimore | Maryland | 21218 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| Minneapolis Vascular Physicians | Plymouth | Minnesota | 55441 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Advance Vascular Associates (Morristown Memorial Hospital) | Morristown | New Jersey | 07960 | United States |
| Albany Medical Center | Albany | New York | 12208 | United States |
| New York University Medical Center | New York | New York | 10016 | United States |
| Mount Sinai School of Medicine | New York | New York | 10029 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Shadyside Hospital - University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15232 | United States |
| Baptist Memorial Hospital | Memphis | Tennessee | 38120 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| St. Luke's Episcopal Hospital - Houston | Houston | Texas | 77030 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | United States |
| COMPLETED |
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| NOT COMPLETED |
|
|
| 30-day to 365-day Post Treatment |
|
|
| 365-day to 60-month Post Treatment |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Valiant Thoracic Stent Graft System | Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants That Did NOT Experience Aneurysm-Related Mortality (Post-market Primary Endpoint) | Evaluation of the ARM-free rate in subjects implanted with the Valiant Thoracic Stent Graft five years post-implantation by comparing it to a pre-defined performance goal (PG) based on an analysis of ARM-free rates from TEVAR data and on results from the VALOR (Talent Thoracic Endoluminal Stent Graft, IDE G980116) clinical study. | Subjects treated or intended to treat with the test device | Posted | Number | 90% Confidence Interval | Percentage of participants | 0 through 1825 days post treatment |
|
|
| |||||||||||||||||||||||||
| Secondary | Percentage of Subjects That Experienced Successful Deployment and Delivery of the Stent Graft at Implant | Percentage of subjects that experienced successful deployment and delivery of the stent graft at implant. Successful deployment and delivery of the stent graft is used to measure effectiveness. | Subjects treated or intended to treat with the test device | Posted | Number | 95% Confidence Interval | Percentage of participants | At implant |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants That Experienced Perioperative Mortality | Percentage of subjects that experienced perioperative mortality. Perioperative morality is defined as all-cause mortality within 30 days after index procedure. | Subjects treated or intended to treat with the test device | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 30 days post treatment |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants That Experienced Paraplegia | Percentage of subjects that experienced paraplegia within 30 days post treatment | Subjects treated or intended to treat with the test device | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 30 days post treatment |
|
| ||||||||||||||||||||||||||
| Primary | Percentage of Participants With Successful Aneurysm Treatment (Primary Effectiveness Endpoint) | Percentage of subjects with absence of both: a) aneurysm growth of more than 5 mm at the 12-month visit relative to the 1-month visit; and b) secondary procedure due to type I or III endoleak performed or recommended at or before the 12-month visit. Success means a subject experienced neither a nor b. Type I: endoleak in continuity with the proximal anchoring site(proximal endoleak) or the distal anchoring site(distal endoleak)of the device. Type III: endoleak is present in the mid-graft region due to defect of fabric or between the segments of the modular graft (junctional endoleak). | Subjects treated or intended to treat with the test device | Posted | Number | 95% Confidence Interval | Percentage of Participants | At 12-month post procedure |
|
| ||||||||||||||||||||||||||
| Primary | Percentage of Participants Who Died (Primary Safety Endpoint: All-Cause Mortality) > > | The percentage of participants who died within 12-months of the initial procedure, whether or not the cause of death was related to the study device, procedure, or condition treated. > > Note: All-cause mortality endpoint is not directly related to successful aneurysm treatment, which pertains to the absence of aneurysm growth and secondary procedure due to Type I and III endoleaks. | Subjects treated or intended to treat with the test device | Posted | Number | 95% Confidence Interval | Percentage of Participants | Within 12-months post treatment |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants That Experienced Paraparesis | Percentage of subjects that experienced paraparesis within 30 days post treatment | Subjects treated or intended to treat with the test device | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 30 days post treatment |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants That Experienced Secondary Procedures Due to Endoleak After Discharge | Percentage of subjects that experienced secondary procedures due to endoleak after discharge within 30 days post treatment | Subjects treated or intended to treat with the test device | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 30 days post treatment |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants That Experienced One or More Major Adverse Events | Percentage of subjects that experienced one or more major adverse events within 30 days post treatment, regardless of relatedness to study device | Subjects treated or intended to treat with the test device | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 30 days post treatment |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants That Experienced Aneurysm-related Mortality | Percentage of subjects that experienced aneurysm-related mortality within 12 months post treatment | Subjects treated or intended to treat with the test device, excluding subjects exited before 12 months and implant failures | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 12 months post treatment |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants That Experience Aneurysm Rupture | Percentage of subjects that experience aneurysm rupture within 12 months post treatment | Subjects treated or intended to treat with the test device excluding subjects that exited before 12 months | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 12 months post treatment |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants That Experienced Conversion to Open Surgical Repair | Percentage of subjects that experienced conversion to open surgical repair within 12 months post treatment | Subjects treated or intended to treat with the test device excluding subjects exited before 12 months | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 12 months post treatment |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants That Experienced Endoleak(s) | Percentage of subjects that experienced endoleak(s) of any type at 12 months | Subjects treated or intended to treat with the test device excluding subjects that did not have proper imaging to identify endoleaks | Posted | Number | 95% Confidence Interval | Percentage of participants | At 12 months |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants That Experienced Secondary Endovascular Procedures Due to Endoleak | Percentage of subjects that experienced secondary endovascular procedures due to endoleak between 30 days and 12 months | Subjects treated or intended to treat with the test device excluding censored subjects (those with no data within the time frame) | Posted | Number | 95% Confidence Interval | Percentage of participants | Between 30 days and 12 months |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants That Experienced Stent Graft Migration | Percentage of subjects that experienced stent graft migration within 12 months post treatment, as reported by the CEC. Of note, all migrations resulted from anatomical accommodation of the stent graft. All migrations were at the distal end of the stent graft, moving proximally. No endoleaks were associated to these migrations. | Subjects treated or intended to treat with the test device, excluding subjects that did not have proper imaging | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 12 months post treatment |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants That Experience Loss of Stent Graft Patency | Percentage of subjects that experience loss of stent graft patency within 12 months post treatment | Subjects treated or intended to treat with the test device, excluding subjects that did not have proper imaging | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 12 months post treatment |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants That Experienced One or More Major Adverse Events | Percentage of subjects that experienced one or more Major Adverse Events within 12 months post treatment | Subjects treated or intended to treat with the test device, excluded subjects that exited before 12 months | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 12 months post treatment |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants That Died (All-cause Mortality) | Percentage of subjects that died (all-cause mortality) five years post implant, regardless whether or not the cause of death was related to procedure, device, or condition treated | Subjects treated or intended to treat with the test device | Posted | Number | Percentage of participants | 0 through 1825 days post treatment |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants That Experienced Aneurysm-related Mortality | Percentage of subjects that experienced aneurysm-related within five years post implant | Subjects treated or intended to treat with the test device | Posted | Number | Percentage of participants | 0 through 1825 days post treatment |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants That Experienced Aneurysm Ruptures | Percentage of subjects that experienced aneurysm ruptures within five years post implant | Subjects treated or intended to treat with the test device | Posted | Number | Percentage of participants | 0 through 1825 days post treatment |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants That Experienced Conversions to Open Surgical Repair | Percentage of subjects that experienced conversions to open surgical repair within five years post implant | Subjects treated or intended to treat with the test device | Posted | Number | Percentage of participants | 0 through 1825 days post treatment |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants That Experienced Type I Endoleaks | Percentage of subjects that experienced type I endoleaks within five years post implant | Subjects treated or intended to treat with the test device | Posted | Number | Percentage of participants | 0 through 1825 days post treatment |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants That Experienced Type III Endoleaks | Percentage of subjects that experienced type III endoleaks within five years post implant | Subjects treated or intended to treat with the test device | Posted | Number | Percentage of participants | 0 through 1825 days post treatment |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants That Experienced Type IV Endoleaks | Percentage of subjects that experienced type IV endoleaks within five years post implant | Subjects treated or intended to treat with the test device | Posted | Number | Percentage of participants | 0 through 1825 days post treatment |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants That Experienced Secondary Endovascular Procedures | Percentage of subjects that experienced secondary endovascular procedures within five years post implant | Subjects treated or intended to treat with the test device | Posted | Number | Percentage of participants | 0 through 1825 days post treatment |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants That Experienced Stent Graft Migrations (Site Reported) | Percentage of subjects that experienced stent graft migrations within five years post implant, as reported by the clinical sites | Subjects treated or intended to treat with the test device | Posted | Number | Percentage of participants | 0 through 1825 days post treatment |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants That Experienced Loss of Stent Graft Patency | Percentage of subjects that experienced loss of stent graft patency within five years post implant | Subjects treated or intended to treat with the test device | Posted | Number | Percentage of participants | 0 through 1825 days post treatment |
|
|
60 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Valiant Thoracic Stent Graft System | 160 subjects were enrolled into the study, including 157 subjects treated with the study device and three subjects classified as intent-to-treat who did not receive the study device. There were no other arms for this study. | 135 | 160 | 160 | 160 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Abdominal wound dehiscence | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Anaemia macrocytic | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Anaemia of chronic disease | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA 13.1 | Systematic Assessment | Includes non-treated aneurysm, such as abdominal aneurysms, and aneurysm expansion of treated aneurysms |
|
| Aortic aneurysm rupture | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Aortic dissection | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Aortic rupture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Aortic valve stenosis | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Arterial injury | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Arterial occlusive disease | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Asbestosis | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Bladder catheter replacement | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
| |
| Blood lactic acid increased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Choking | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cholecystectomy | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
| |
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Chronic myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Clostridial infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Colostomy closure | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
| |
| Complication of device insertion | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Coronary angioplasty | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 13.1 | Systematic Assessment | Unknown cause of death. Overall in the study, there were 54 deaths (46 not related to the TAA; 8 related to the TAA). However, this death could not be classified any further, as site was unable to obtain any information associated to it. |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Device deployment issue | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Endocardial fibroelastosis | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Eyeball rupture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Faeces discoloured | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Femoral arterial stenosis | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Gouty arthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Groin abscess | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Heparin-induced thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hernia repair | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypertensive emergency | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypoxic-ischaemic encephalopathy | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Infusion site extravasation | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Lymphocele | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Medical device complication | General disorders | MedDRA 13.1 | Systematic Assessment | Right prosthetic knee infection |
|
| Mental status changes | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment | E.g., Confusion, aphasia, and disorientation |
|
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Multiple myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Non-small cell lung cancer stage IIIB | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Normochromic normocytic anaemia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Open wound | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Operative haemorrhage | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Panic disorder | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Paraparesis | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Paraplegia | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Peripheral artery aneurysm | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Peripheral artery dissection | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Peripheral embolism | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Pneumonia herpes viral | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Poor peripheral circulation | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Post lumbar puncture syndrome | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Prostatomegaly | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pulmonary embolism | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Renal failure chronic | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Retroperitoneal haemorrhage | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Small cell lung cancer stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Soft tissue necrosis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Spinal cord ischaemia | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Splenic embolism | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Stent-graft endoleak | General disorders | MedDRA 13.1 | Systematic Assessment | TAA endoleaks: Type I, 9 events; Type II, 3; Type V/Unknown, 3. AAA endoleaks: 2 events |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Systemic candida | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Traumatic haematoma | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Urinary tract infection pseudomonal | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Varices oesophageal | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Vascular pseudoaneurysm ruptured | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Ventricular tachyarrhythmia | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Vessel puncture site haematoma | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Vocal cord paralysis | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Wound infection staphylococcal | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| arteriovenous fistula | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA 13.1 | Systematic Assessment | Includes non-treated aneurysm, such as abdominal aneurysms, and aneurysm expansion of treated aneurysms |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Haematocrit decreased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment | E.g. Confusion, worsening memory, and anxiety |
|
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Stent-graft endoleak | General disorders | MedDRA 13.1 | Systematic Assessment | TAA endoleaks: Type I, 6 events; Type II, 20; Type III, 1; Type IV, 2; Type V/Unknown, 5. AAA endoleaks: 3 events. |
|
| Urinary tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Vessel puncture site haematoma | General disorders | MedDRA 13.1 | Systematic Assessment |
|
Adverse Events and Serious Adverse Events listed in ClinicalTrials.gov were re-coded, using MedDRA 13.1. To do so, events were reclassified. As a result, data in listings may not match those in Clinical Update reports, SSEDs, or Instructions for Use.
The Principal Investigator (PI) and institution agree not to publish the results of the study until after the earliest of the following: a)conclusion of the study, b)the early termination of the study, c)at discretion and approval of the sponsor, or d)after sponsor confirms there will be no multicenter study publication, whichever occurs first. PI and institution further agree to submit to sponsor copies of any proposed publication or public presentation at least sixty days before dissemination.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| PJ Belmont, Clinical Research Specialist | Medtronic Vascular, Inc. | 707-480-3025 | PJ.Belmont@Medtronic.com |
| ID | Term |
|---|---|
| D017545 | Aortic Aneurysm, Thoracic |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
Not provided
Not provided
| Exited after surgical conversion |
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