Trial Outcomes & Findings for HORIZON CE Pivotal Study to Treat Abdominal Aortic Aneurysm (NCT NCT02087501)

NCT ID: NCT02087501

Last Updated: 2023-12-05

Results Overview

Safety endpoint includes proportion of patients free from MAEs within 1 month post implantation, as adjudicated by an independent clinical events committee (CEC).

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

1 month post implantation

Results posted on

2023-12-05

Participant Flow

Study population included 30 patients enrolled in Hospitals, enrollment period lasted 1 year.

There were no events occurring after patient enrollment and before assignment of the single arm foreseen by the study protocol

Participant milestones

Participant milestones
Measure	HORIZON AAA Stent Graft System All eligible patients received the HORIZON AAA (Abdominal Aortic Aneurysm) Stent Graft System.
Overall Study STARTED	30
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	HORIZON AAA Stent Graft System All eligible patients received the HORIZON AAA (Abdominal Aortic Aneurysm) Stent Graft System.
Overall Study Death	7
Overall Study Open repair of aneurysm	1
Overall Study Lost to Follow-up	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HORIZON AAA Stent Graft n=30 Participants All eligible patients received the HORIZON AAA (Abdominal Aortic Aneurysm) Stent Graft System.
Age, Continuous	69.3 years STANDARD_DEVIATION 7.9 • n=30 Participants
Sex: Female, Male Female	1 Participants n=30 Participants
Sex: Female, Male Male	29 Participants n=30 Participants
Region of Enrollment Netherlands	2 participants n=30 Participants
Region of Enrollment Italy	12 participants n=30 Participants
Region of Enrollment Serbia	11 participants n=30 Participants
Region of Enrollment Switzerland	5 participants n=30 Participants

PRIMARY outcome

Timeframe: 1 month post implantation

Population: The safety analysis population consisted of all subjects for whom the implantation procedure was initiated (i.e. date of implantation was not missing). Out of the 30 subjects in the safety analysis set, none had Major Adverse Events (MAEs) within 1 month, and therefore the sample proportion of subjects having MAE's within 1 month is 0%. The 95% confidence interval is \[0%, 11.6%\], meaning that we are 95% confident that the proportion of subjects having MAE's within 1 month is lower than 11.6%.

Safety endpoint includes proportion of patients free from MAEs within 1 month post implantation, as adjudicated by an independent clinical events committee (CEC).

Outcome measures

Outcome measures
Measure	HORIZON AAA Stent Graft n=30 Participants All eligible patients received the HORIZON AAA (Abdominal Aortic Aneurysm) Stent Graft System.
Safety Endpoint: Major Adverse Events (MAEs)	30 Participants

PRIMARY outcome

Timeframe: 1 month post implant

Population: All subjects for whom the implantation procedure was initiated and for whom there were no major entry violations likely to affect outcome

Performance endpoints will assess the rate of successful aneurysm treatment at 1 month, defined as: * Successful delivery and deployment of the device. * Absence of the following, as determined by an independent core-lab: aneurysm growth ≥5mm, type I or III endoleaks, stent graft occlusion, conversion to open surgery, rupture and clinically significant stent graft migration.

Outcome measures

Outcome measures
Measure	HORIZON AAA Stent Graft n=30 Participants All eligible patients received the HORIZON AAA (Abdominal Aortic Aneurysm) Stent Graft System.
Performance Endpoint	30 Participants

SECONDARY outcome

Timeframe: 1 month - 5 years post implantation

Population: All patients for whom the implantation procedure was initiated and for whom there was no major entry violation

Proportion of patients free from MAEs at 1 month through 5 years post implantation.

Outcome measures

Outcome measures
Measure	HORIZON AAA Stent Graft n=30 Participants All eligible patients received the HORIZON AAA (Abdominal Aortic Aneurysm) Stent Graft System.
MAEs	24 Participants

SECONDARY outcome

Timeframe: 12 months

All-cause mortality and aneurysm-related mortality at 12 months, Kaplan-Meier survival analysis.

Outcome measures

Outcome measures
Measure	HORIZON AAA Stent Graft n=30 Participants All eligible patients received the HORIZON AAA (Abdominal Aortic Aneurysm) Stent Graft System.
Mortality	93.3 percentage free from mortality Interval 75.9 to 98.3

SECONDARY outcome

Timeframe: 12 months post implantation

Absence of all of the following at 1 year: aneurysm growth ≥5mm, type I or III endoleaks, stent graft occlusion, conversion to open surgery, rupture and stent graft migration.

Outcome measures

Outcome measures
Measure	HORIZON AAA Stent Graft n=28 Participants All eligible patients received the HORIZON AAA (Abdominal Aortic Aneurysm) Stent Graft System.
Secondary Performance Endpoint	28 Participants

Adverse Events

HORIZON AAA Stent Graft

Serious events: 19 serious events

Other events: 18 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	HORIZON AAA Stent Graft n=30 participants at risk All eligible patients received the HORIZON AAA (Abdominal Aortic Aneurysm) Stent Graft System.
Cardiac disorders Coronary artery disease	3.3% 1/30 • Number of events 1 • For each patient, adverse events were collected for 5 years after implantation of the device. The definitions of AE and SAE follow the standard ISO14155. MAEs (used for the assessment of endpoints) are defined as: all-cause mortality, myocardial infarction, renal failure (excludes renal insufficiency), respiratory failure (excludes chronic obstructive pulmonary disease or polmunary complications), paraplegia (excludes paraparesis), stroke (excludes transient ischemic attack), bowel ischemia and procedural blood loss ≥ 1000ml.
Cardiac disorders Myocardial infarction	10.0% 3/30 • Number of events 3 • For each patient, adverse events were collected for 5 years after implantation of the device. The definitions of AE and SAE follow the standard ISO14155. MAEs (used for the assessment of endpoints) are defined as: all-cause mortality, myocardial infarction, renal failure (excludes renal insufficiency), respiratory failure (excludes chronic obstructive pulmonary disease or polmunary complications), paraplegia (excludes paraparesis), stroke (excludes transient ischemic attack), bowel ischemia and procedural blood loss ≥ 1000ml.
Gastrointestinal disorders Inguinal hernia	3.3% 1/30 • Number of events 1 • For each patient, adverse events were collected for 5 years after implantation of the device. The definitions of AE and SAE follow the standard ISO14155. MAEs (used for the assessment of endpoints) are defined as: all-cause mortality, myocardial infarction, renal failure (excludes renal insufficiency), respiratory failure (excludes chronic obstructive pulmonary disease or polmunary complications), paraplegia (excludes paraparesis), stroke (excludes transient ischemic attack), bowel ischemia and procedural blood loss ≥ 1000ml.
General disorders Pyrexia	3.3% 1/30 • Number of events 1 • For each patient, adverse events were collected for 5 years after implantation of the device. The definitions of AE and SAE follow the standard ISO14155. MAEs (used for the assessment of endpoints) are defined as: all-cause mortality, myocardial infarction, renal failure (excludes renal insufficiency), respiratory failure (excludes chronic obstructive pulmonary disease or polmunary complications), paraplegia (excludes paraparesis), stroke (excludes transient ischemic attack), bowel ischemia and procedural blood loss ≥ 1000ml.
General disorders Stent-graft endoleak	6.7% 2/30 • Number of events 2 • For each patient, adverse events were collected for 5 years after implantation of the device. The definitions of AE and SAE follow the standard ISO14155. MAEs (used for the assessment of endpoints) are defined as: all-cause mortality, myocardial infarction, renal failure (excludes renal insufficiency), respiratory failure (excludes chronic obstructive pulmonary disease or polmunary complications), paraplegia (excludes paraparesis), stroke (excludes transient ischemic attack), bowel ischemia and procedural blood loss ≥ 1000ml.
General disorders Sudden cardiac death	3.3% 1/30 • Number of events 1 • For each patient, adverse events were collected for 5 years after implantation of the device. The definitions of AE and SAE follow the standard ISO14155. MAEs (used for the assessment of endpoints) are defined as: all-cause mortality, myocardial infarction, renal failure (excludes renal insufficiency), respiratory failure (excludes chronic obstructive pulmonary disease or polmunary complications), paraplegia (excludes paraparesis), stroke (excludes transient ischemic attack), bowel ischemia and procedural blood loss ≥ 1000ml.
Infections and infestations Infectious pleural effusion	3.3% 1/30 • Number of events 1 • For each patient, adverse events were collected for 5 years after implantation of the device. The definitions of AE and SAE follow the standard ISO14155. MAEs (used for the assessment of endpoints) are defined as: all-cause mortality, myocardial infarction, renal failure (excludes renal insufficiency), respiratory failure (excludes chronic obstructive pulmonary disease or polmunary complications), paraplegia (excludes paraparesis), stroke (excludes transient ischemic attack), bowel ischemia and procedural blood loss ≥ 1000ml.
Infections and infestations Pneumonia	3.3% 1/30 • Number of events 1 • For each patient, adverse events were collected for 5 years after implantation of the device. The definitions of AE and SAE follow the standard ISO14155. MAEs (used for the assessment of endpoints) are defined as: all-cause mortality, myocardial infarction, renal failure (excludes renal insufficiency), respiratory failure (excludes chronic obstructive pulmonary disease or polmunary complications), paraplegia (excludes paraparesis), stroke (excludes transient ischemic attack), bowel ischemia and procedural blood loss ≥ 1000ml.
Infections and infestations Wound infection	3.3% 1/30 • Number of events 1 • For each patient, adverse events were collected for 5 years after implantation of the device. The definitions of AE and SAE follow the standard ISO14155. MAEs (used for the assessment of endpoints) are defined as: all-cause mortality, myocardial infarction, renal failure (excludes renal insufficiency), respiratory failure (excludes chronic obstructive pulmonary disease or polmunary complications), paraplegia (excludes paraparesis), stroke (excludes transient ischemic attack), bowel ischemia and procedural blood loss ≥ 1000ml.
Injury, poisoning and procedural complications Multiple injuries	3.3% 1/30 • Number of events 1 • For each patient, adverse events were collected for 5 years after implantation of the device. The definitions of AE and SAE follow the standard ISO14155. MAEs (used for the assessment of endpoints) are defined as: all-cause mortality, myocardial infarction, renal failure (excludes renal insufficiency), respiratory failure (excludes chronic obstructive pulmonary disease or polmunary complications), paraplegia (excludes paraparesis), stroke (excludes transient ischemic attack), bowel ischemia and procedural blood loss ≥ 1000ml.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric neoplasm	3.3% 1/30 • Number of events 1 • For each patient, adverse events were collected for 5 years after implantation of the device. The definitions of AE and SAE follow the standard ISO14155. MAEs (used for the assessment of endpoints) are defined as: all-cause mortality, myocardial infarction, renal failure (excludes renal insufficiency), respiratory failure (excludes chronic obstructive pulmonary disease or polmunary complications), paraplegia (excludes paraparesis), stroke (excludes transient ischemic attack), bowel ischemia and procedural blood loss ≥ 1000ml.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	3.3% 1/30 • Number of events 1 • For each patient, adverse events were collected for 5 years after implantation of the device. The definitions of AE and SAE follow the standard ISO14155. MAEs (used for the assessment of endpoints) are defined as: all-cause mortality, myocardial infarction, renal failure (excludes renal insufficiency), respiratory failure (excludes chronic obstructive pulmonary disease or polmunary complications), paraplegia (excludes paraparesis), stroke (excludes transient ischemic attack), bowel ischemia and procedural blood loss ≥ 1000ml.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip and /or oral cavity cancer	3.3% 1/30 • Number of events 1 • For each patient, adverse events were collected for 5 years after implantation of the device. The definitions of AE and SAE follow the standard ISO14155. MAEs (used for the assessment of endpoints) are defined as: all-cause mortality, myocardial infarction, renal failure (excludes renal insufficiency), respiratory failure (excludes chronic obstructive pulmonary disease or polmunary complications), paraplegia (excludes paraparesis), stroke (excludes transient ischemic attack), bowel ischemia and procedural blood loss ≥ 1000ml.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	3.3% 1/30 • Number of events 1 • For each patient, adverse events were collected for 5 years after implantation of the device. The definitions of AE and SAE follow the standard ISO14155. MAEs (used for the assessment of endpoints) are defined as: all-cause mortality, myocardial infarction, renal failure (excludes renal insufficiency), respiratory failure (excludes chronic obstructive pulmonary disease or polmunary complications), paraplegia (excludes paraparesis), stroke (excludes transient ischemic attack), bowel ischemia and procedural blood loss ≥ 1000ml.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	3.3% 1/30 • Number of events 1 • For each patient, adverse events were collected for 5 years after implantation of the device. The definitions of AE and SAE follow the standard ISO14155. MAEs (used for the assessment of endpoints) are defined as: all-cause mortality, myocardial infarction, renal failure (excludes renal insufficiency), respiratory failure (excludes chronic obstructive pulmonary disease or polmunary complications), paraplegia (excludes paraparesis), stroke (excludes transient ischemic attack), bowel ischemia and procedural blood loss ≥ 1000ml.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	3.3% 1/30 • Number of events 1 • For each patient, adverse events were collected for 5 years after implantation of the device. The definitions of AE and SAE follow the standard ISO14155. MAEs (used for the assessment of endpoints) are defined as: all-cause mortality, myocardial infarction, renal failure (excludes renal insufficiency), respiratory failure (excludes chronic obstructive pulmonary disease or polmunary complications), paraplegia (excludes paraparesis), stroke (excludes transient ischemic attack), bowel ischemia and procedural blood loss ≥ 1000ml.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	3.3% 1/30 • Number of events 1 • For each patient, adverse events were collected for 5 years after implantation of the device. The definitions of AE and SAE follow the standard ISO14155. MAEs (used for the assessment of endpoints) are defined as: all-cause mortality, myocardial infarction, renal failure (excludes renal insufficiency), respiratory failure (excludes chronic obstructive pulmonary disease or polmunary complications), paraplegia (excludes paraparesis), stroke (excludes transient ischemic attack), bowel ischemia and procedural blood loss ≥ 1000ml.
Nervous system disorders Cerebrovascular accident	3.3% 1/30 • Number of events 1 • For each patient, adverse events were collected for 5 years after implantation of the device. The definitions of AE and SAE follow the standard ISO14155. MAEs (used for the assessment of endpoints) are defined as: all-cause mortality, myocardial infarction, renal failure (excludes renal insufficiency), respiratory failure (excludes chronic obstructive pulmonary disease or polmunary complications), paraplegia (excludes paraparesis), stroke (excludes transient ischemic attack), bowel ischemia and procedural blood loss ≥ 1000ml.
Renal and urinary disorders Renal failure	3.3% 1/30 • Number of events 1 • For each patient, adverse events were collected for 5 years after implantation of the device. The definitions of AE and SAE follow the standard ISO14155. MAEs (used for the assessment of endpoints) are defined as: all-cause mortality, myocardial infarction, renal failure (excludes renal insufficiency), respiratory failure (excludes chronic obstructive pulmonary disease or polmunary complications), paraplegia (excludes paraparesis), stroke (excludes transient ischemic attack), bowel ischemia and procedural blood loss ≥ 1000ml.
Respiratory, thoracic and mediastinal disorders Respiratory failure	3.3% 1/30 • Number of events 1 • For each patient, adverse events were collected for 5 years after implantation of the device. The definitions of AE and SAE follow the standard ISO14155. MAEs (used for the assessment of endpoints) are defined as: all-cause mortality, myocardial infarction, renal failure (excludes renal insufficiency), respiratory failure (excludes chronic obstructive pulmonary disease or polmunary complications), paraplegia (excludes paraparesis), stroke (excludes transient ischemic attack), bowel ischemia and procedural blood loss ≥ 1000ml.
Surgical and medical procedures Coronary artery bypass and aortic valve replacement	3.3% 1/30 • Number of events 1 • For each patient, adverse events were collected for 5 years after implantation of the device. The definitions of AE and SAE follow the standard ISO14155. MAEs (used for the assessment of endpoints) are defined as: all-cause mortality, myocardial infarction, renal failure (excludes renal insufficiency), respiratory failure (excludes chronic obstructive pulmonary disease or polmunary complications), paraplegia (excludes paraparesis), stroke (excludes transient ischemic attack), bowel ischemia and procedural blood loss ≥ 1000ml.
Surgical and medical procedures Cardiac pacemaker insertion	3.3% 1/30 • Number of events 1 • For each patient, adverse events were collected for 5 years after implantation of the device. The definitions of AE and SAE follow the standard ISO14155. MAEs (used for the assessment of endpoints) are defined as: all-cause mortality, myocardial infarction, renal failure (excludes renal insufficiency), respiratory failure (excludes chronic obstructive pulmonary disease or polmunary complications), paraplegia (excludes paraparesis), stroke (excludes transient ischemic attack), bowel ischemia and procedural blood loss ≥ 1000ml.
Vascular disorders Aneurysm	3.3% 1/30 • Number of events 1 • For each patient, adverse events were collected for 5 years after implantation of the device. The definitions of AE and SAE follow the standard ISO14155. MAEs (used for the assessment of endpoints) are defined as: all-cause mortality, myocardial infarction, renal failure (excludes renal insufficiency), respiratory failure (excludes chronic obstructive pulmonary disease or polmunary complications), paraplegia (excludes paraparesis), stroke (excludes transient ischemic attack), bowel ischemia and procedural blood loss ≥ 1000ml.
Vascular disorders Haemorrhage	3.3% 1/30 • Number of events 1 • For each patient, adverse events were collected for 5 years after implantation of the device. The definitions of AE and SAE follow the standard ISO14155. MAEs (used for the assessment of endpoints) are defined as: all-cause mortality, myocardial infarction, renal failure (excludes renal insufficiency), respiratory failure (excludes chronic obstructive pulmonary disease or polmunary complications), paraplegia (excludes paraparesis), stroke (excludes transient ischemic attack), bowel ischemia and procedural blood loss ≥ 1000ml.
Vascular disorders Peripheral arterial occlusive disease	3.3% 1/30 • Number of events 1 • For each patient, adverse events were collected for 5 years after implantation of the device. The definitions of AE and SAE follow the standard ISO14155. MAEs (used for the assessment of endpoints) are defined as: all-cause mortality, myocardial infarction, renal failure (excludes renal insufficiency), respiratory failure (excludes chronic obstructive pulmonary disease or polmunary complications), paraplegia (excludes paraparesis), stroke (excludes transient ischemic attack), bowel ischemia and procedural blood loss ≥ 1000ml.

Other adverse events

Other adverse events
Measure	HORIZON AAA Stent Graft n=30 participants at risk All eligible patients received the HORIZON AAA (Abdominal Aortic Aneurysm) Stent Graft System.
Musculoskeletal and connective tissue disorders Spondylolisthesis	3.3% 1/30 • Number of events 1 • For each patient, adverse events were collected for 5 years after implantation of the device. The definitions of AE and SAE follow the standard ISO14155. MAEs (used for the assessment of endpoints) are defined as: all-cause mortality, myocardial infarction, renal failure (excludes renal insufficiency), respiratory failure (excludes chronic obstructive pulmonary disease or polmunary complications), paraplegia (excludes paraparesis), stroke (excludes transient ischemic attack), bowel ischemia and procedural blood loss ≥ 1000ml.
Nervous system disorders Headache	3.3% 1/30 • Number of events 1 • For each patient, adverse events were collected for 5 years after implantation of the device. The definitions of AE and SAE follow the standard ISO14155. MAEs (used for the assessment of endpoints) are defined as: all-cause mortality, myocardial infarction, renal failure (excludes renal insufficiency), respiratory failure (excludes chronic obstructive pulmonary disease or polmunary complications), paraplegia (excludes paraparesis), stroke (excludes transient ischemic attack), bowel ischemia and procedural blood loss ≥ 1000ml.
Nervous system disorders Restless legs syndrome	3.3% 1/30 • Number of events 1 • For each patient, adverse events were collected for 5 years after implantation of the device. The definitions of AE and SAE follow the standard ISO14155. MAEs (used for the assessment of endpoints) are defined as: all-cause mortality, myocardial infarction, renal failure (excludes renal insufficiency), respiratory failure (excludes chronic obstructive pulmonary disease or polmunary complications), paraplegia (excludes paraparesis), stroke (excludes transient ischemic attack), bowel ischemia and procedural blood loss ≥ 1000ml.
Renal and urinary disorders Nephrolithiasis	3.3% 1/30 • Number of events 2 • For each patient, adverse events were collected for 5 years after implantation of the device. The definitions of AE and SAE follow the standard ISO14155. MAEs (used for the assessment of endpoints) are defined as: all-cause mortality, myocardial infarction, renal failure (excludes renal insufficiency), respiratory failure (excludes chronic obstructive pulmonary disease or polmunary complications), paraplegia (excludes paraparesis), stroke (excludes transient ischemic attack), bowel ischemia and procedural blood loss ≥ 1000ml.
Renal and urinary disorders Renal cyst	3.3% 1/30 • Number of events 1 • For each patient, adverse events were collected for 5 years after implantation of the device. The definitions of AE and SAE follow the standard ISO14155. MAEs (used for the assessment of endpoints) are defined as: all-cause mortality, myocardial infarction, renal failure (excludes renal insufficiency), respiratory failure (excludes chronic obstructive pulmonary disease or polmunary complications), paraplegia (excludes paraparesis), stroke (excludes transient ischemic attack), bowel ischemia and procedural blood loss ≥ 1000ml.
Renal and urinary disorders Renal failure	3.3% 1/30 • Number of events 1 • For each patient, adverse events were collected for 5 years after implantation of the device. The definitions of AE and SAE follow the standard ISO14155. MAEs (used for the assessment of endpoints) are defined as: all-cause mortality, myocardial infarction, renal failure (excludes renal insufficiency), respiratory failure (excludes chronic obstructive pulmonary disease or polmunary complications), paraplegia (excludes paraparesis), stroke (excludes transient ischemic attack), bowel ischemia and procedural blood loss ≥ 1000ml.
Renal and urinary disorders Renal infarct	3.3% 1/30 • Number of events 1 • For each patient, adverse events were collected for 5 years after implantation of the device. The definitions of AE and SAE follow the standard ISO14155. MAEs (used for the assessment of endpoints) are defined as: all-cause mortality, myocardial infarction, renal failure (excludes renal insufficiency), respiratory failure (excludes chronic obstructive pulmonary disease or polmunary complications), paraplegia (excludes paraparesis), stroke (excludes transient ischemic attack), bowel ischemia and procedural blood loss ≥ 1000ml.
Reproductive system and breast disorders Erectile dysfunction	3.3% 1/30 • Number of events 1 • For each patient, adverse events were collected for 5 years after implantation of the device. The definitions of AE and SAE follow the standard ISO14155. MAEs (used for the assessment of endpoints) are defined as: all-cause mortality, myocardial infarction, renal failure (excludes renal insufficiency), respiratory failure (excludes chronic obstructive pulmonary disease or polmunary complications), paraplegia (excludes paraparesis), stroke (excludes transient ischemic attack), bowel ischemia and procedural blood loss ≥ 1000ml.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	3.3% 1/30 • Number of events 1 • For each patient, adverse events were collected for 5 years after implantation of the device. The definitions of AE and SAE follow the standard ISO14155. MAEs (used for the assessment of endpoints) are defined as: all-cause mortality, myocardial infarction, renal failure (excludes renal insufficiency), respiratory failure (excludes chronic obstructive pulmonary disease or polmunary complications), paraplegia (excludes paraparesis), stroke (excludes transient ischemic attack), bowel ischemia and procedural blood loss ≥ 1000ml.
Vascular disorders Hypertension	3.3% 1/30 • Number of events 1 • For each patient, adverse events were collected for 5 years after implantation of the device. The definitions of AE and SAE follow the standard ISO14155. MAEs (used for the assessment of endpoints) are defined as: all-cause mortality, myocardial infarction, renal failure (excludes renal insufficiency), respiratory failure (excludes chronic obstructive pulmonary disease or polmunary complications), paraplegia (excludes paraparesis), stroke (excludes transient ischemic attack), bowel ischemia and procedural blood loss ≥ 1000ml.
Vascular disorders Intermittent claudication	3.3% 1/30 • Number of events 1 • For each patient, adverse events were collected for 5 years after implantation of the device. The definitions of AE and SAE follow the standard ISO14155. MAEs (used for the assessment of endpoints) are defined as: all-cause mortality, myocardial infarction, renal failure (excludes renal insufficiency), respiratory failure (excludes chronic obstructive pulmonary disease or polmunary complications), paraplegia (excludes paraparesis), stroke (excludes transient ischemic attack), bowel ischemia and procedural blood loss ≥ 1000ml.
Vascular disorders Vasospasm	3.3% 1/30 • Number of events 1 • For each patient, adverse events were collected for 5 years after implantation of the device. The definitions of AE and SAE follow the standard ISO14155. MAEs (used for the assessment of endpoints) are defined as: all-cause mortality, myocardial infarction, renal failure (excludes renal insufficiency), respiratory failure (excludes chronic obstructive pulmonary disease or polmunary complications), paraplegia (excludes paraparesis), stroke (excludes transient ischemic attack), bowel ischemia and procedural blood loss ≥ 1000ml.
General disorders Stent-graft endoleak	13.3% 4/30 • Number of events 4 • For each patient, adverse events were collected for 5 years after implantation of the device. The definitions of AE and SAE follow the standard ISO14155. MAEs (used for the assessment of endpoints) are defined as: all-cause mortality, myocardial infarction, renal failure (excludes renal insufficiency), respiratory failure (excludes chronic obstructive pulmonary disease or polmunary complications), paraplegia (excludes paraparesis), stroke (excludes transient ischemic attack), bowel ischemia and procedural blood loss ≥ 1000ml.
Blood and lymphatic system disorders Splenomegaly	3.3% 1/30 • Number of events 1 • For each patient, adverse events were collected for 5 years after implantation of the device. The definitions of AE and SAE follow the standard ISO14155. MAEs (used for the assessment of endpoints) are defined as: all-cause mortality, myocardial infarction, renal failure (excludes renal insufficiency), respiratory failure (excludes chronic obstructive pulmonary disease or polmunary complications), paraplegia (excludes paraparesis), stroke (excludes transient ischemic attack), bowel ischemia and procedural blood loss ≥ 1000ml.
Cardiac disorders Cardiac failure congestive	3.3% 1/30 • Number of events 1 • For each patient, adverse events were collected for 5 years after implantation of the device. The definitions of AE and SAE follow the standard ISO14155. MAEs (used for the assessment of endpoints) are defined as: all-cause mortality, myocardial infarction, renal failure (excludes renal insufficiency), respiratory failure (excludes chronic obstructive pulmonary disease or polmunary complications), paraplegia (excludes paraparesis), stroke (excludes transient ischemic attack), bowel ischemia and procedural blood loss ≥ 1000ml.
Gastrointestinal disorders Constipation	3.3% 1/30 • Number of events 1 • For each patient, adverse events were collected for 5 years after implantation of the device. The definitions of AE and SAE follow the standard ISO14155. MAEs (used for the assessment of endpoints) are defined as: all-cause mortality, myocardial infarction, renal failure (excludes renal insufficiency), respiratory failure (excludes chronic obstructive pulmonary disease or polmunary complications), paraplegia (excludes paraparesis), stroke (excludes transient ischemic attack), bowel ischemia and procedural blood loss ≥ 1000ml.
Gastrointestinal disorders Diaphragmatic hernia	3.3% 1/30 • Number of events 1 • For each patient, adverse events were collected for 5 years after implantation of the device. The definitions of AE and SAE follow the standard ISO14155. MAEs (used for the assessment of endpoints) are defined as: all-cause mortality, myocardial infarction, renal failure (excludes renal insufficiency), respiratory failure (excludes chronic obstructive pulmonary disease or polmunary complications), paraplegia (excludes paraparesis), stroke (excludes transient ischemic attack), bowel ischemia and procedural blood loss ≥ 1000ml.
Gastrointestinal disorders Vomiting	3.3% 1/30 • Number of events 1 • For each patient, adverse events were collected for 5 years after implantation of the device. The definitions of AE and SAE follow the standard ISO14155. MAEs (used for the assessment of endpoints) are defined as: all-cause mortality, myocardial infarction, renal failure (excludes renal insufficiency), respiratory failure (excludes chronic obstructive pulmonary disease or polmunary complications), paraplegia (excludes paraparesis), stroke (excludes transient ischemic attack), bowel ischemia and procedural blood loss ≥ 1000ml.
General disorders Chronic fatigue syndrome	3.3% 1/30 • Number of events 1 • For each patient, adverse events were collected for 5 years after implantation of the device. The definitions of AE and SAE follow the standard ISO14155. MAEs (used for the assessment of endpoints) are defined as: all-cause mortality, myocardial infarction, renal failure (excludes renal insufficiency), respiratory failure (excludes chronic obstructive pulmonary disease or polmunary complications), paraplegia (excludes paraparesis), stroke (excludes transient ischemic attack), bowel ischemia and procedural blood loss ≥ 1000ml.
General disorders Pirexia	13.3% 4/30 • Number of events 4 • For each patient, adverse events were collected for 5 years after implantation of the device. The definitions of AE and SAE follow the standard ISO14155. MAEs (used for the assessment of endpoints) are defined as: all-cause mortality, myocardial infarction, renal failure (excludes renal insufficiency), respiratory failure (excludes chronic obstructive pulmonary disease or polmunary complications), paraplegia (excludes paraparesis), stroke (excludes transient ischemic attack), bowel ischemia and procedural blood loss ≥ 1000ml.
Hepatobiliary disorders Cholelithiasis	3.3% 1/30 • Number of events 1 • For each patient, adverse events were collected for 5 years after implantation of the device. The definitions of AE and SAE follow the standard ISO14155. MAEs (used for the assessment of endpoints) are defined as: all-cause mortality, myocardial infarction, renal failure (excludes renal insufficiency), respiratory failure (excludes chronic obstructive pulmonary disease or polmunary complications), paraplegia (excludes paraparesis), stroke (excludes transient ischemic attack), bowel ischemia and procedural blood loss ≥ 1000ml.
Infections and infestations Bronchiolitis	3.3% 1/30 • Number of events 1 • For each patient, adverse events were collected for 5 years after implantation of the device. The definitions of AE and SAE follow the standard ISO14155. MAEs (used for the assessment of endpoints) are defined as: all-cause mortality, myocardial infarction, renal failure (excludes renal insufficiency), respiratory failure (excludes chronic obstructive pulmonary disease or polmunary complications), paraplegia (excludes paraparesis), stroke (excludes transient ischemic attack), bowel ischemia and procedural blood loss ≥ 1000ml.
Injury, poisoning and procedural complications Rib fracture	3.3% 1/30 • Number of events 1 • For each patient, adverse events were collected for 5 years after implantation of the device. The definitions of AE and SAE follow the standard ISO14155. MAEs (used for the assessment of endpoints) are defined as: all-cause mortality, myocardial infarction, renal failure (excludes renal insufficiency), respiratory failure (excludes chronic obstructive pulmonary disease or polmunary complications), paraplegia (excludes paraparesis), stroke (excludes transient ischemic attack), bowel ischemia and procedural blood loss ≥ 1000ml.
Injury, poisoning and procedural complications Spinal fracture	3.3% 1/30 • Number of events 1 • For each patient, adverse events were collected for 5 years after implantation of the device. The definitions of AE and SAE follow the standard ISO14155. MAEs (used for the assessment of endpoints) are defined as: all-cause mortality, myocardial infarction, renal failure (excludes renal insufficiency), respiratory failure (excludes chronic obstructive pulmonary disease or polmunary complications), paraplegia (excludes paraparesis), stroke (excludes transient ischemic attack), bowel ischemia and procedural blood loss ≥ 1000ml.
Metabolism and nutrition disorders Fluid overload	3.3% 1/30 • Number of events 1 • For each patient, adverse events were collected for 5 years after implantation of the device. The definitions of AE and SAE follow the standard ISO14155. MAEs (used for the assessment of endpoints) are defined as: all-cause mortality, myocardial infarction, renal failure (excludes renal insufficiency), respiratory failure (excludes chronic obstructive pulmonary disease or polmunary complications), paraplegia (excludes paraparesis), stroke (excludes transient ischemic attack), bowel ischemia and procedural blood loss ≥ 1000ml.
Musculoskeletal and connective tissue disorders Arthralgia	6.7% 2/30 • Number of events 2 • For each patient, adverse events were collected for 5 years after implantation of the device. The definitions of AE and SAE follow the standard ISO14155. MAEs (used for the assessment of endpoints) are defined as: all-cause mortality, myocardial infarction, renal failure (excludes renal insufficiency), respiratory failure (excludes chronic obstructive pulmonary disease or polmunary complications), paraplegia (excludes paraparesis), stroke (excludes transient ischemic attack), bowel ischemia and procedural blood loss ≥ 1000ml.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	3.3% 1/30 • Number of events 1 • For each patient, adverse events were collected for 5 years after implantation of the device. The definitions of AE and SAE follow the standard ISO14155. MAEs (used for the assessment of endpoints) are defined as: all-cause mortality, myocardial infarction, renal failure (excludes renal insufficiency), respiratory failure (excludes chronic obstructive pulmonary disease or polmunary complications), paraplegia (excludes paraparesis), stroke (excludes transient ischemic attack), bowel ischemia and procedural blood loss ≥ 1000ml.

Additional Information

Jessica Kleine

Endospan

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place