Trial Outcomes & Findings for Post-Market Registry of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Implanted in Peripheral Vessels (NCT NCT03720704)
NCT ID: NCT03720704
Last Updated: 2025-04-01
Results Overview
Number of study subjects experiencing Procedural Success and free from VBX Stent Graft-related Serious Adverse Events within 30 days of index procedure. Procedural Success is defined as: successful access, delivery, accurate deployment, and withdrawal of catheters with patent VBX Stent Graft at end of procedure.
Recruitment status
ACTIVE_NOT_RECRUITING
Target enrollment
280 participants
Primary outcome timeframe
30 days post treatment
Results posted on
2025-04-01
Participant Flow
Participant milestones
| Measure |
GORE VIABAHN VBX Balloon Expandable Endoprosthesis
The GORE VIABAHN VBX Balloon Expandable Endoprosthesis will be implanted according to the institution standard of practice in patients needing preservation of peripheral vessels due to multiple pathologies and conditions.
GORE VIABAHN VBX Balloon Expandable Endoprosthesis: GORE VIABAHN VBX Balloon Expandable Endoprosthesis will be implanted in peripheral vessels in patients who require interventional treatment.
|
|---|---|
|
Overall Study
STARTED
|
280
|
|
Overall Study
COMPLETED
|
210
|
|
Overall Study
NOT COMPLETED
|
70
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
GORE VIABAHN VBX Balloon Expandable Endoprosthesis
n=280 Participants
The GORE VIABAHN VBX Balloon Expandable Endoprosthesis will be implanted according to the institution standard of practice in patients needing preservation of peripheral vessels due to multiple pathologies and conditions.
GORE VIABAHN VBX Balloon Expandable Endoprosthesis: GORE VIABAHN VBX Balloon Expandable Endoprosthesis will be implanted in peripheral vessels in patients who require interventional treatment.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=280 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
68 Participants
n=280 Participants
|
|
Age, Categorical
>=65 years
|
212 Participants
n=280 Participants
|
|
Age, Continuous
|
70.7 years
STANDARD_DEVIATION 9.7 • n=280 Participants
|
|
Sex: Female, Male
Female
|
75 Participants
n=280 Participants
|
|
Sex: Female, Male
Male
|
205 Participants
n=280 Participants
|
|
Region of Enrollment
Netherlands
|
60 Participants
n=280 Participants
|
|
Region of Enrollment
Italy
|
77 Participants
n=280 Participants
|
|
Region of Enrollment
France
|
8 Participants
n=280 Participants
|
|
Region of Enrollment
Germany
|
92 Participants
n=280 Participants
|
|
Region of Enrollment
Spain
|
43 Participants
n=280 Participants
|
PRIMARY outcome
Timeframe: 30 days post treatmentNumber of study subjects experiencing Procedural Success and free from VBX Stent Graft-related Serious Adverse Events within 30 days of index procedure. Procedural Success is defined as: successful access, delivery, accurate deployment, and withdrawal of catheters with patent VBX Stent Graft at end of procedure.
Outcome measures
| Measure |
GORE VIABAHN VBX Balloon Expandable Endoprosthesis
n=280 Participants
The GORE VIABAHN VBX Balloon Expandable Endoprosthesis will be implanted according to the institution standard of practice in patients needing preservation of peripheral vessels due to multiple pathologies and conditions.
GORE VIABAHN VBX Balloon Expandable Endoprosthesis: GORE VIABAHN VBX Balloon Expandable Endoprosthesis will be implanted in peripheral vessels in patients who require interventional treatment.
|
|---|---|
|
Composite of Procedural Success and Freedom From VBX Stent Graft-related Serious Adverse Events
|
274 Participants
|
Adverse Events
GORE VIABAHN VBX Balloon Expandable Endoprosthesis
Serious events: 153 serious events
Other events: 15 other events
Deaths: 49 deaths
Serious adverse events
| Measure |
GORE VIABAHN VBX Balloon Expandable Endoprosthesis
n=280 participants at risk
The GORE VIABAHN VBX Balloon Expandable Endoprosthesis will be implanted according to the institution standard of practice in patients needing preservation of peripheral vessels due to multiple pathologies and conditions.
GORE VIABAHN VBX Balloon Expandable Endoprosthesis: GORE VIABAHN VBX Balloon Expandable Endoprosthesis will be implanted in peripheral vessels in patients who require interventional treatment.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
1.4%
4/280 • Number of events 4 • 1 year
|
|
Blood and lymphatic system disorders
Blood loss anemia
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Macrocytic anemia
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Cardiac disorders
Acute coronary syndrome
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Cardiac disorders
Acute heart failure
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Cardiac disorders
Acute myocardial infarction
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Cardiac disorders
Acute myocardial infarction type 2
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Cardiac disorders
Aortic valve insufficiency
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Cardiac disorders
Atrial fibrillation
|
1.1%
3/280 • Number of events 3 • 1 year
|
|
Cardiac disorders
Atrioventricular block
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Cardiac disorders
Cardiac arrest
|
0.71%
2/280 • Number of events 2 • 1 year
|
|
Cardiac disorders
Cardiac asthma
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Cardiac disorders
Cardiac ischaemia
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Cardiac disorders
Cardiac ischemia
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Cardiac disorders
Cardiac rupture
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Cardiac disorders
Congestive heart failure
|
1.1%
3/280 • Number of events 3 • 1 year
|
|
Cardiac disorders
Coronary heart disease
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Cardiac disorders
Decompensation cardiac
|
1.8%
5/280 • Number of events 5 • 1 year
|
|
Cardiac disorders
Heart failure
|
1.1%
3/280 • Number of events 3 • 1 year
|
|
Cardiac disorders
Mitral valve insufficiency
|
0.71%
2/280 • Number of events 2 • 1 year
|
|
Cardiac disorders
Myocardial infarction
|
0.71%
2/280 • Number of events 3 • 1 year
|
|
Cardiac disorders
Non STEMI
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Cardiac disorders
Right heart failure
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Cardiac disorders
Ventricular tachycardia
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
1.1%
3/280 • Number of events 3 • 1 year
|
|
Gastrointestinal disorders
Abdominal wall hematoma
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Bowel ischemia
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Bowel obstruction
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Celiac artery stenosis
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Femoral hernia
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal bleeding
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Hematochezia
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Intestinal polyp bleeding
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Ischemic colitis
|
0.71%
2/280 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Mesenteric artery embolism
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Mesenteric ischemia
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Pancreatitis
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Proctorrhagia
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Retroperitoneal hematoma
|
0.71%
2/280 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Splenic artery aneurysm
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
General disorders
Arterial stent occlusion
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
General disorders
Death from natural causes
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
General disorders
Distal stent-induced new entry
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
General disorders
Extravasation of drug
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
General disorders
In-stent arterial restenosis
|
1.4%
4/280 • Number of events 5 • 1 year
|
|
General disorders
In-stent arterial stenosis
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
General disorders
In-stent venous restenosis
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
General disorders
Malaise
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
General disorders
Multi organ failure
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
General disorders
Multiorgan failure
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
General disorders
Reduced general condition
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
General disorders
Renal stent-graft thrombosis
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
General disorders
Stent thrombosis
|
0.71%
2/280 • Number of events 2 • 1 year
|
|
General disorders
Stent-graft endoleak type IA
|
1.4%
4/280 • Number of events 4 • 1 year
|
|
General disorders
Stent-graft endoleak type IB
|
1.4%
4/280 • Number of events 4 • 1 year
|
|
General disorders
Stent-graft endoleak type IC
|
1.8%
5/280 • Number of events 5 • 1 year
|
|
General disorders
Stent-graft endoleak type II
|
3.6%
10/280 • Number of events 12 • 1 year
|
|
General disorders
Stent-graft endoleak type III
|
1.4%
4/280 • Number of events 5 • 1 year
|
|
General disorders
Stent-graft endoleak type IIIA
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
General disorders
Stent-graft stenosis
|
0.71%
2/280 • Number of events 3 • 1 year
|
|
General disorders
Stent-graft thrombosis
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
General disorders
Systemic inflammatory response syndrome
|
0.71%
2/280 • Number of events 2 • 1 year
|
|
General disorders
Unknown cause of death
|
1.4%
4/280 • Number of events 4 • 1 year
|
|
General disorders
Wound healing disturbance of
|
0.71%
2/280 • Number of events 3 • 1 year
|
|
Hepatobiliary disorders
Acute cholecystitis
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Hepatobiliary disorders
Hepatic artery stenosis
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Infections and infestations
Bacteremia
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Infections and infestations
Bacterial endocarditis
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Infections and infestations
COVID-19
|
1.1%
3/280 • Number of events 3 • 1 year
|
|
Infections and infestations
COVID-19 pneumonia
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Infections and infestations
Endocarditis
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Infections and infestations
Gastroenteritis
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Infections and infestations
Graft infection
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Infections and infestations
Infected seroma
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Infections and infestations
Infected toe
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Infections and infestations
Meningitis
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Infections and infestations
Necrotizing fasciitis
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Infections and infestations
Pneumococcal sepsis
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Infections and infestations
Pneumonia
|
2.9%
8/280 • Number of events 8 • 1 year
|
|
Infections and infestations
Postoperative wound infection
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Infections and infestations
Prosthesis related infection
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Infections and infestations
Puncture site infection
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Infections and infestations
Pyelonephritis
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Infections and infestations
SARS-CoV-2 infection
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Infections and infestations
Sepsis
|
2.5%
7/280 • Number of events 7 • 1 year
|
|
Infections and infestations
Septic shock
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
1.1%
3/280 • Number of events 3 • 1 year
|
|
Infections and infestations
Urosepsis
|
0.71%
2/280 • Number of events 2 • 1 year
|
|
Infections and infestations
Vascular stent infection
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Infections and infestations
Wound infection
|
0.71%
2/280 • Number of events 2 • 1 year
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site stenosis
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Arteriovenous graft site stenosis
|
0.71%
2/280 • Number of events 2 • 1 year
|
|
Injury, poisoning and procedural complications
False aneurysm
|
0.71%
2/280 • Number of events 2 • 1 year
|
|
Injury, poisoning and procedural complications
Femoral artery pseudoaneurysm
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Femur fracture subtrochanteric
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Fractured ribs
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Postimplantation syndrome
|
1.1%
3/280 • Number of events 3 • 1 year
|
|
Injury, poisoning and procedural complications
Postoperative hematoma
|
0.71%
2/280 • Number of events 2 • 1 year
|
|
Injury, poisoning and procedural complications
Vascular access site occlusion
|
0.71%
2/280 • Number of events 2 • 1 year
|
|
Injury, poisoning and procedural complications
Vascular access site thrombosis
|
1.1%
3/280 • Number of events 9 • 1 year
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
1.4%
4/280 • Number of events 5 • 1 year
|
|
Injury, poisoning and procedural complications
Vascular graft thrombosis
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Wound bleeding
|
0.71%
2/280 • Number of events 2 • 1 year
|
|
Investigations
Aspiration bronchial
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Coxarthrosis
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Gonarthrosis
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Low back pain
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Soft tissue necrosis
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ameloblastic carcinoma
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma metastatic
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder tumor
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric neoplasm
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.71%
2/280 • Number of events 2 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kidney cancer
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer
|
0.71%
2/280 • Number of events 2 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic breast cancer
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate carcinoma
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Nervous system disorders
Anterior spinal artery syndrome
|
1.1%
3/280 • Number of events 3 • 1 year
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Nervous system disorders
Dural arteriovenous fistula
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Nervous system disorders
Hemorrhagic stroke
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Nervous system disorders
Ischemic stroke
|
0.71%
2/280 • Number of events 3 • 1 year
|
|
Nervous system disorders
Middle cerebral artery stroke
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Nervous system disorders
Spinal cord ischemia
|
1.1%
3/280 • Number of events 3 • 1 year
|
|
Nervous system disorders
Stroke
|
0.71%
2/280 • Number of events 2 • 1 year
|
|
Nervous system disorders
Transient ischemic attack
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Product Issues
Device dislocation
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Product Issues
Device migration
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Product Issues
Stent migration
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Product Issues
Stent occlusion
|
2.9%
8/280 • Number of events 9 • 1 year
|
|
Renal and urinary disorders
Acute kidney injury
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Acute on chronic renal failure
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Acute renal failure
|
1.1%
3/280 • Number of events 3 • 1 year
|
|
Renal and urinary disorders
Acute renal insufficiency
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Renal artery dissection
|
1.1%
3/280 • Number of events 3 • 1 year
|
|
Renal and urinary disorders
Renal artery occlusion
|
1.4%
4/280 • Number of events 5 • 1 year
|
|
Renal and urinary disorders
Renal failure
|
1.4%
4/280 • Number of events 4 • 1 year
|
|
Renal and urinary disorders
Renal function aggravated
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Renal insufficiency
|
0.71%
2/280 • Number of events 2 • 1 year
|
|
Renal and urinary disorders
Urinary retention
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary edema
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
COPD exacerbation
|
0.71%
2/280 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease exacerbation
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.36%
1/280 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hemothorax
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxemia
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.71%
2/280 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.71%
2/280 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory insufficiency
|
0.71%
2/280 • Number of events 2 • 1 year
|
|
Skin and subcutaneous tissue disorders
Heel ulcer
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Hepatectomy
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Radical nephrectomy
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Vascular disorders
Aneurysm enlargement
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Vascular disorders
Aneurysm of aortic arch
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Vascular disorders
Aortic thrombosis
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Vascular disorders
Arterial stenosis
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Vascular disorders
Brachiocephalic vein stenosis
|
0.36%
1/280 • Number of events 2 • 1 year
|
|
Vascular disorders
Femoral artery thrombosis
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Vascular disorders
Hematoma
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Vascular disorders
Hypovolemic shock
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Vascular disorders
Iliac artery aneurysm
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Vascular disorders
Iliac artery occlusion
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Vascular disorders
Iliac artery restenosis
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Vascular disorders
Iliac artery stenosis
|
1.1%
3/280 • Number of events 3 • 1 year
|
|
Vascular disorders
Iliac artery thrombosis
|
1.1%
3/280 • Number of events 4 • 1 year
|
|
Vascular disorders
Limb ischemia
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Vascular disorders
Lower limb ischemia
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Vascular disorders
Lymphatic fistula
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Vascular disorders
Peripheral arterial disease
|
0.36%
1/280 • Number of events 2 • 1 year
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Vascular disorders
Peripheral arterial occlusive disease Fontaine stage III
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Vascular disorders
Peripheral arterial occlusive disease Fontaine stage IIb
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Vascular disorders
Phlebitis arm
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Vascular disorders
Popliteal artery aneurysm
|
0.71%
2/280 • Number of events 3 • 1 year
|
|
Vascular disorders
Subclavian artery thrombosis
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Vascular disorders
Superficial femoral arterial stenosis
|
0.36%
1/280 • Number of events 2 • 1 year
|
|
Vascular disorders
Superficial femoral artery occlusion
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Vascular disorders
Thoracic aortic aneurysm
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Vascular disorders
Thoracic aortic aneurysm enlargement
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Vascular disorders
Type A aortic dissection
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Vascular disorders
Type B aortic dissection
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Vascular disorders
Vascular stenosis
|
0.36%
1/280 • Number of events 1 • 1 year
|
|
Vascular disorders
Venous stenosis
|
0.36%
1/280 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
GORE VIABAHN VBX Balloon Expandable Endoprosthesis
n=280 participants at risk
The GORE VIABAHN VBX Balloon Expandable Endoprosthesis will be implanted according to the institution standard of practice in patients needing preservation of peripheral vessels due to multiple pathologies and conditions.
GORE VIABAHN VBX Balloon Expandable Endoprosthesis: GORE VIABAHN VBX Balloon Expandable Endoprosthesis will be implanted in peripheral vessels in patients who require interventional treatment.
|
|---|---|
|
General disorders
Stent-graft endoleak type II
|
5.4%
15/280 • Number of events 17 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place