Trial Outcomes & Findings for VIVO Clinical Study (NCT NCT01970007)
NCT ID: NCT01970007
Last Updated: 2021-04-08
Results Overview
Major adverse events were defined as procedural bleeding requiring transfusion, procedure- or device-related death, clinically driven target lesion reintervention, clinical migration, new symptomatic PE, or procedure-related perforation requiring open surgical repair or flow-limiting dissection of the target vessel.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
243 participants
Primary outcome timeframe
30 days
Results posted on
2021-04-08
Participant Flow
Participant milestones
| Measure |
Zilver Vena Venous Self-Expanding Stent
Zilver® Vena™ Venous Stent in the treatment of symptomatic iliofemoral venous outflow obstruction.
|
|---|---|
|
Overall Study
STARTED
|
243
|
|
Overall Study
COMPLETED
|
188
|
|
Overall Study
NOT COMPLETED
|
55
|
Reasons for withdrawal
| Measure |
Zilver Vena Venous Self-Expanding Stent
Zilver® Vena™ Venous Stent in the treatment of symptomatic iliofemoral venous outflow obstruction.
|
|---|---|
|
Overall Study
Death
|
5
|
|
Overall Study
Withdrawal by Subject
|
23
|
|
Overall Study
Lost to Follow-up
|
24
|
|
Overall Study
"Other" endpoint
|
3
|
Baseline Characteristics
VIVO Clinical Study
Baseline characteristics by cohort
| Measure |
Zilver Vena Venous Self-Expanding Stent
n=243 Participants
Zilver® Vena™ Venous Stent in the treatment of symptomatic iliofemoral venous outflow obstruction.
|
|---|---|
|
Age, Continuous
|
53.0 Years
STANDARD_DEVIATION 15.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
170 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
73 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
29 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
First Nations / White
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
198 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: The study protocol specified the analysis be based on the intent-to-treat population, which includes all 243 enrolled patients. Among the 243 enrolled patients, data for the primary safety endpoint were available for 240 patients. Therefore, because the number of analyzable patients exceeded the minimum sample size required for sufficient statistical power (n=218), the primary analysis was based on the analyzable population in accordance with the study protocol.
Major adverse events were defined as procedural bleeding requiring transfusion, procedure- or device-related death, clinically driven target lesion reintervention, clinical migration, new symptomatic PE, or procedure-related perforation requiring open surgical repair or flow-limiting dissection of the target vessel.
Outcome measures
| Measure |
Zilver Vena Venous Self-Expanding Stent
n=240 Participants
Zilver® Vena™ Venous Stent in the treatment of symptomatic iliofemoral venous outflow obstruction.
|
|---|---|
|
Number of Participants With 30-day Freedom From Major Adverse Events
|
232 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: The study protocol specified the primary analysis be based on intent-to-treat population (n=243). Among the 243 enrolled patients, 189 patients had venographic primary patency outcome data available (i.e., post-procedure and 12-month venogram data). Therefore, the results presented are after the outcome was imputed multiple times by random sampling from the Bernoulli distribution based on outcomes for the analyzable patients (n=189) without covariate adjustment.
Primary quantitative patency was defined as a treated venous segment that retained (uninterrupted; intervention-free) an MLD (Minimum Lumen Diameter ) \> 50% of the immediate post-procedure stented MLD as demonstrated by venography as determined by the core laboratory.
Outcome measures
| Measure |
Zilver Vena Venous Self-Expanding Stent
n=243 Participants
Zilver® Vena™ Venous Stent in the treatment of symptomatic iliofemoral venous outflow obstruction.
|
|---|---|
|
The Rate of Participants With Primary Quantitative Patency at 12 Months
|
89.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and 1 monthPopulation: All participants with baseline and 1-month Venous Clinical Severity Score (VCSS) available. Venous Clinical Severity Score (VCSS) were available for 233 patients at 1 month.
Venous Clinical Severity Score (VCSS) is a method of classifying venous disease severity based on 10 clinical descriptors (pain, varicose veins, venous edema, skin pigmentation, inflammation, induration, number of active ulcers, duration of active ulcer, size of active ulcer, and use of compression therapy), each scored on a scale from 0 (Absent) to 3 (Severe). The VCSS score is the sum of the scores for the individual descriptors, ranging from 0 to 30. Mean change = (1-month score - Baseline Score)
Outcome measures
| Measure |
Zilver Vena Venous Self-Expanding Stent
n=243 Participants
Zilver® Vena™ Venous Stent in the treatment of symptomatic iliofemoral venous outflow obstruction.
|
|---|---|
|
Change From Baseline in the Venous Clinical Severity Score (VCSS) at 1 Month
At baseline
|
8.0 units on a scale
Standard Deviation 4.2
|
|
Change From Baseline in the Venous Clinical Severity Score (VCSS) at 1 Month
Change from baseline at 1 month
|
-3.0 units on a scale
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: All participants with baseline and 12-months Venous Clinical Severity Score (VCSS) available. Venous Clinical Severity Score (VCSS) were available for 202 patients at 12 months.
Venous Clinical Severity Score (VCSS) is a method of classifying venous disease severity based on 10 clinical descriptors (pain, varicose veins, venous edema, skin pigmentation, inflammation, induration, number of active ulcers, duration of active ulcer, size of active ulcer, and use of compression therapy), each scored on a scale from 0 (Absent) to 3 (Severe). The VCSS score is the sum of the scores for the individual descriptors, ranging from 0 to 30. Mean change = (12-month score - Baseline Score)
Outcome measures
| Measure |
Zilver Vena Venous Self-Expanding Stent
n=243 Participants
Zilver® Vena™ Venous Stent in the treatment of symptomatic iliofemoral venous outflow obstruction.
|
|---|---|
|
Change From Baseline in the Venous Clinical Severity Score (VCSS) at 12 Months
At baseline
|
8.0 units on a scale
Standard Deviation 4.2
|
|
Change From Baseline in the Venous Clinical Severity Score (VCSS) at 12 Months
Change from baseline at 12 months
|
-4.2 units on a scale
Standard Deviation 0.2
|
Adverse Events
Zilver Vena Venous Stent
Serious events: 111 serious events
Other events: 84 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Zilver Vena Venous Stent
n=243 participants at risk
Zilver Vena Venous Stent: stenting
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.2%
3/243 • Number of events 3 • 3 year
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.41%
1/243 • Number of events 2 • 3 year
|
|
Cardiac disorders
Angina pectoris
|
0.82%
2/243 • Number of events 3 • 3 year
|
|
Cardiac disorders
Aortic valve incompetence
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Cardiac disorders
Arrhythmia
|
1.2%
3/243 • Number of events 3 • 3 year
|
|
Cardiac disorders
Atrial fibrillation
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Cardiac disorders
Cardiac failure
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Cardiac disorders
Cardiac failure acute
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Cardiac disorders
Cardiac failure congestive
|
0.82%
2/243 • Number of events 3 • 3 year
|
|
Cardiac disorders
Cardiogenic shock
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Cardiac disorders
Coronary artery disease
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Cardiac disorders
Myocardial infarction
|
0.82%
2/243 • Number of events 2 • 3 year
|
|
Cardiac disorders
Tachycardia
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Endocrine disorders
Goiter
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Eye disorders
Corneal degeneration
|
0.41%
1/243 • Number of events 2 • 3 year
|
|
Eye disorders
Orbital haemorrhage
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Gastrointestinal disorders
Abdominal mass
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Gastrointestinal disorders
Abdominal pain
|
2.1%
5/243 • Number of events 8 • 3 year
|
|
Gastrointestinal disorders
Constipation
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Gastrointestinal disorders
Diarrhoea
|
0.82%
2/243 • Number of events 2 • 3 year
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Gastrointestinal disorders
Intestinal fistula
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Gastrointestinal disorders
Nausea
|
1.2%
3/243 • Number of events 4 • 3 year
|
|
Gastrointestinal disorders
Rectal obstruction
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.82%
2/243 • Number of events 6 • 3 year
|
|
Gastrointestinal disorders
Vomiting
|
0.82%
2/243 • Number of events 2 • 3 year
|
|
General disorders
Chest pain
|
1.2%
3/243 • Number of events 3 • 3 year
|
|
General disorders
Hernia
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
General disorders
Nodule
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
General disorders
Non-cardiac chest pain
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
General disorders
Oedema
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
General disorders
Pain
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
General disorders
Pelvic mass
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
General disorders
Peripheral swelling
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
General disorders
Pyrexia
|
0.82%
2/243 • Number of events 2 • 3 year
|
|
General disorders
Surgical failure
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
General disorders
Ulcer
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
General disorders
Vascular stent occlusion
|
6.2%
15/243 • Number of events 17 • 3 year
|
|
General disorders
Vascular stent restenosis
|
2.5%
6/243 • Number of events 8 • 3 year
|
|
General disorders
Vascular stent stenosis
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
General disorders
Vascular stent thrombosis
|
2.5%
6/243 • Number of events 7 • 3 year
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Infections and infestations
Babesiosis
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Infections and infestations
Bronchitis
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Infections and infestations
Cellulitis
|
2.1%
5/243 • Number of events 9 • 3 year
|
|
Infections and infestations
Chronic sinusitis
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Infections and infestations
Localised infection
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Infections and infestations
Meningitis
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Infections and infestations
Osteomyelitis
|
0.82%
2/243 • Number of events 2 • 3 year
|
|
Infections and infestations
Pelvic infection
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Infections and infestations
Perineal abscess
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Infections and infestations
Pneumonia
|
1.2%
3/243 • Number of events 3 • 3 year
|
|
Infections and infestations
Post procedural infection
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Infections and infestations
Sepsis
|
2.9%
7/243 • Number of events 11 • 3 year
|
|
Infections and infestations
Urinary tract infection
|
0.82%
2/243 • Number of events 3 • 3 year
|
|
Infections and infestations
Wound infection
|
0.82%
2/243 • Number of events 2 • 3 year
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Injury, poisoning and procedural complications
Contusion
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Injury, poisoning and procedural complications
Fall
|
1.6%
4/243 • Number of events 6 • 3 year
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.82%
2/243 • Number of events 2 • 3 year
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
1.2%
3/243 • Number of events 3 • 3 year
|
|
Injury, poisoning and procedural complications
Injury
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Injury, poisoning and procedural complications
Limb traumatic amputation
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Injury, poisoning and procedural complications
Overdose
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.82%
2/243 • Number of events 2 • 3 year
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Injury, poisoning and procedural complications
Traumatic liver injury
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Injury, poisoning and procedural complications
Vascular access site haematoma
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Investigations
Blood bilirubin increased
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Investigations
Blood glucose increased
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Investigations
Blood magnesium decreased
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Investigations
Blood pressure decreased
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Investigations
Coagulation time prolonged
|
6.2%
15/243 • Number of events 16 • 3 year
|
|
Investigations
Hepatic enzyme increased
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Investigations
Liver function test increased
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Metabolism and nutrition disorders
Dehydration
|
0.82%
2/243 • Number of events 2 • 3 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.82%
2/243 • Number of events 2 • 3 year
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.2%
3/243 • Number of events 3 • 3 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.2%
3/243 • Number of events 3 • 3 year
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Musculoskeletal and connective tissue disorders
Fracture nonunion
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protusion
|
1.2%
3/243 • Number of events 3 • 3 year
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.1%
5/243 • Number of events 7 • 3 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.2%
3/243 • Number of events 3 • 3 year
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukemia
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukemia
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Angiomyolipoma
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.82%
2/243 • Number of events 2 • 3 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.82%
2/243 • Number of events 2 • 3 year
|
|
Nervous system disorders
Cerebrovascular accident
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Nervous system disorders
Migraine
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Nervous system disorders
Myastenia gravis
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Nervous system disorders
Myoclonus
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Nervous system disorders
Sciatica
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Nervous system disorders
Spinal claudication
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Nervous system disorders
Syncope
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Nervous system disorders
Transient ischemic attack
|
1.2%
3/243 • Number of events 3 • 3 year
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Product Issues
Device dislocation
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Psychiatric disorders
Depression
|
0.82%
2/243 • Number of events 2 • 3 year
|
|
Psychiatric disorders
Suicidal ideation
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Renal and urinary disorders
Acute kidney injury
|
1.6%
4/243 • Number of events 4 • 3 year
|
|
Renal and urinary disorders
Calculus bladder
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Renal and urinary disorders
Haematuria
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Renal and urinary disorders
Hydronephrosis
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.82%
2/243 • Number of events 2 • 3 year
|
|
Renal and urinary disorders
Renal failure
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Renal and urinary disorders
Urinary retention
|
0.82%
2/243 • Number of events 2 • 3 year
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Reproductive system and breast disorders
Adnexal torsion
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Reproductive system and breast disorders
Menometrorrhagia
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.82%
2/243 • Number of events 2 • 3 year
|
|
Reproductive system and breast disorders
Pelvic haematoma
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Reproductive system and breast disorders
Pelvic prolapse
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.6%
4/243 • Number of events 5 • 3 year
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.9%
7/243 • Number of events 8 • 3 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.6%
4/243 • Number of events 4 • 3 year
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Skin and subcutaneous tissue disorders
Diabetic wound
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.82%
2/243 • Number of events 3 • 3 year
|
|
Surgical and medical procedures
Cholecystectomy
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Surgical and medical procedures
Colostomy
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Surgical and medical procedures
Faecal management
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Surgical and medical procedures
Metabolic surgery
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Vascular disorders
Aortic aneurysm
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Vascular disorders
Arterial occlusive disease
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Vascular disorders
Deep vein thrombosis
|
2.1%
5/243 • Number of events 5 • 3 year
|
|
Vascular disorders
Embolism
|
0.41%
1/243 • Number of events 3 • 3 year
|
|
Vascular disorders
Femoral artery aneurysm
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Vascular disorders
Haemorrhage
|
6.2%
15/243 • Number of events 16 • 3 year
|
|
Vascular disorders
Hypertension
|
0.82%
2/243 • Number of events 2 • 3 year
|
|
Vascular disorders
Iliac vein stenosis
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Vascular disorders
Intermittent claudication
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Vascular disorders
May-Thurner syndrome
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Vascular disorders
Orthostatic hypotension
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Vascular disorders
Peripheral embolism
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Vascular disorders
Vascular occlusion
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Vascular disorders
Vascular wall hypertrophy
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Vascular disorders
Vena cava thrombosis
|
0.41%
1/243 • Number of events 1 • 3 year
|
|
Vascular disorders
Venous occlusion
|
0.41%
1/243 • Number of events 1 • 3 year
|
Other adverse events
| Measure |
Zilver Vena Venous Stent
n=243 participants at risk
Zilver Vena Venous Stent: stenting
|
|---|---|
|
General disorders
Peripheral swelling
|
5.3%
13/243 • Number of events 13 • 3 year
|
|
General disorders
Vascular stent occlusion
|
5.8%
14/243 • Number of events 15 • 3 year
|
|
Investigations
Coagulation time prolonged
|
11.1%
27/243 • Number of events 32 • 3 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.3%
25/243 • Number of events 27 • 3 year
|
|
Vascular disorders
Haemorrhage
|
11.5%
28/243 • Number of events 33 • 3 year
|
|
Vascular disorders
Peripheral venous disease
|
7.8%
19/243 • Number of events 36 • 3 year
|
Additional Information
Alan Saunders, MS, RAC; Manager, Biostatistics
Cook Research Incorporated
Phone: 765-463-7537
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60