VIVO Clinical Study

• Sponsor: Cook Research Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01970007
• Collaborator: (none)
• Enrollment: 243
• Locations: 30
• Arm: 1
• Actual Duration (Months): 71.2
• Patients Per Site: 8.1
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of the VIVO Clinical Study is to evaluate the safety and effectiveness of the Zilver® Vena™ Venous Stent in the treatment of symptomatic iliofemoral venous outflow obstruction.

Condition or Disease	Intervention/Treatment	Phase
Symptomatic Venous Outflow Obstruction in the Iliofemoral Vein	Device: Zilver Vena Venous Self-Expanding Stent	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 243 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of the Zilver® Vena™ Venous Stent in the Treatment of Symptomatic Iliofemoral Venous Outflow Obstruction
• Actual Study Start Date: Dec 13, 2013
• Actual Primary Completion Date: Nov 20, 2017
• Actual Study Completion Date: Nov 20, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Zilver Vena Venous Self-Expanding Stent	Device: Zilver Vena Venous Self-Expanding Stent; stenting; Other Names: venous stent

Outcome Measures

Primary Outcome Measures

1. Number of Participants With 30-day Freedom From Major Adverse Events [30 days]

   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.

2. The Rate of Participants With Primary Quantitative Patency at 12 Months [12 months]

   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.

Secondary Outcome Measures

1. Change From Baseline in the Venous Clinical Severity Score (VCSS) at 1 Month [Baseline and 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)

2. Change From Baseline in the Venous Clinical Severity Score (VCSS) at 12 Months [Baseline and 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• symptomatic venous outflow obstruction in one iliofemoral venous segment (i.e., one limb) per patient, demonstrated by:

• CEAP "C" ≥ 3, or

• VCSS pain score ≥ 2

Key Exclusion Criteria:

• < 18 years of age;

• pregnant or planning to become pregnant in the next 12 months;

• planned surgical or interventional procedures of the target limb (except thrombolysis and/or thrombectomy in preparation for the procedure or vena cava filter placement prior to stent implantation in patients at high risk for pulmonary embolism) within 30 days prior to or any time after the study procedure;

• planned surgical or interventional procedures for other medical conditions (i.e., not associated with the target limb) within 30 days prior to or after the study procedure;

• lesions with intended treatment lengths extending into the inferior vena cava or below the level of the lesser trochanter;

• lesion with malignant obstruction;

• previous stenting of the target vessel;

• iliofemoral venous segment unsuitable for treatment with available sizes of study devices.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama Birmingham Hospital	Birmingham	Alabama	United States	35233
2	Arrowhead Hospital	Glendale	Arizona	United States	85308
3	Littleton Adventist Hospital	Littleton	Colorado	United States	80122
4	Yale-New Haven Hospital	New Haven	Connecticut	United States	06510
5	Southern Connecticut Vascular Center - Norwalk Hospital	Norwalk	Connecticut	United States	06856
6	Christiana Care Health Systems	Newark	Delaware	United States	19718
7	Florida Pepin Heart Institute	Tampa	Florida	United States	33613
8	Piedmont Hospital	Atlanta	Georgia	United States	30309
9	Methodist Hospital of Indiana	Indianapolis	Indiana	United States	46202
10	St. Vincent Medical Group	Indianapolis	Indiana	United States	46290
11	University of Iowa	Iowa City	Iowa	United States	52242
12	University of Louisville - Norton Hospital	Louisville	Kentucky	United States	40202
13	Shady Grove Adventist	Rockville	Maryland	United States	20850
14	University of Michigan Health System	Ann Arbor	Michigan	United States	48109
15	Barnes Jewish Hospital Plaza	Saint Louis	Missouri	United States	63110
16	Mercy Hospital	Saint Louis	Missouri	United States	63141
17	CHI Health St. Elizabeth	Lincoln	Nebraska	United States	68510
18	Holy Name Medical Center	Teaneck	New Jersey	United States	07666
19	New York University - Langone Medical Center	New York	New York	United States	10016
20	Carolinas Medical Center	Charlotte	North Carolina	United States	28203
21	Rex Hospital	Raleigh	North Carolina	United States	27607
22	Good Samaritan Hospital	Cincinnati	Ohio	United States	45220
23	ProMedica - Jobst Vascular Institute	Toledo	Ohio	United States	43606
24	Oklahoma State University Medical Center	Tulsa	Oklahoma	United States	74127
25	Temple University Hospital	Philadelphia	Pennsylvania	United States	19140
26	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213
27	Medical University of South Carolina	Charleston	South Carolina	United States	29425
28	Cardiothoracic and Vascular Surgeons	Austin	Texas	United States	78756
29	Utah Valley Regional Medical Center	Provo	Utah	United States	84604
30	Taipei Medical University Wan Fang Hospital	Taipei		Taiwan	116

Sponsors and Collaborators

• Cook Research Incorporated

Investigators

• Principal Investigator: Anthony J. Comerota, MD, FACS, FACC, Inova Vascular
• Principal Investigator: Lawrence "Rusty" Hofmann, MD, Stanford University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 28, 2018

More Information

Publications

None provided.

• Responsible Party: Cook Research Incorporated
• ClinicalTrials.gov Identifier: NCT01970007
• Other Study ID Numbers: 11-010
• First Posted: Oct 25, 2013
• Last Update Posted: Apr 8, 2021
• Last Verified: Mar 1, 2021

• Keywords provided by Cook Research Incorporated: venous; outflow obstruction; iliofemoral vein

Study Results

Participant Flow

Arm/Group Title	Zilver Vena Venous Self-Expanding Stent
Arm/Group Description	Zilver® Vena™ Venous Stent in the treatment of symptomatic iliofemoral venous outflow obstruction.
Period Title: Overall Study
STARTED	243
COMPLETED	188
NOT COMPLETED	55

Baseline Characteristics

Arm/Group Title	Zilver Vena Venous Self-Expanding Stent
Arm/Group Description	Zilver® Vena™ Venous Stent in the treatment of symptomatic iliofemoral venous outflow obstruction.
Overall Participants	243
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	53.0 (15.3)
Sex: Female, Male (Count of Participants)
Female	170 70%
Male	73 30%
Race/Ethnicity, Customized (Count of Participants)
Asian	8 3.3%
Black or African American	29 11.9%
First Nations / White	1 0.4%
Hispanic or Latino	7 2.9%
White	198 81.5%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With 30-day Freedom From Major Adverse Events
Description	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.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Zilver Vena Venous Self-Expanding Stent
Arm/Group Description	Zilver® Vena™ Venous Stent in the treatment of symptomatic iliofemoral venous outflow obstruction.
Measure Participants	240
Count of Participants [Participants]	232 95.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Zilver Vena Venous Self-Expanding Stent
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	One-sided Exact binomial test
	Comments
Method of Estimation	Estimation Parameter	Freedom from MAE rate (%)
	Estimated Value	96.7
	Confidence Interval	(2-Sided) 95%; 93.5 to 98.6
	Parameter Dispersion	Type: Value:
	Estimation Comments	One-sided Exact binomial test

2. Primary Outcome

Title	The Rate of Participants With Primary Quantitative Patency at 12 Months
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Zilver Vena Venous Self-Expanding Stent
Arm/Group Description	Zilver® Vena™ Venous Stent in the treatment of symptomatic iliofemoral venous outflow obstruction.
Measure Participants	243
Number [percentage of participants]	89.9 37%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Zilver Vena Venous Self-Expanding Stent
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Binomial test for one proportion
	Comments
Method of Estimation	Estimation Parameter	12-month quantitative patency rate (%)
	Estimated Value	89.9
	Confidence Interval	(2-Sided) 95%; 85.1 to 93.4
	Parameter Dispersion	Type: Value:
	Estimation Comments	Binomial test for one proportion

3. Secondary Outcome

Title	Change From Baseline in the Venous Clinical Severity Score (VCSS) at 1 Month
Description	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)
Time Frame	Baseline and 1 month

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Zilver Vena Venous Self-Expanding Stent
Arm/Group Description	Zilver® Vena™ Venous Stent in the treatment of symptomatic iliofemoral venous outflow obstruction.
Measure Participants	243
At baseline	8.0 (4.2)
Change from baseline at 1 month	-3.0 (0.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Zilver Vena Venous Self-Expanding Stent
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	P-value is adjusted for multiplicity
	Method	paired t-test
	Comments	A paired t-test with p-values adjusted for multiple comparisons using the Holm's procedure to control for a family-wise Type I error rate of 0.05.
Method of Estimation	Estimation Parameter	Change from Baseline Mean
	Estimated Value	-3.0
	Confidence Interval	(2-Sided) 95%; -3.5 to -2.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Change From Baseline in the Venous Clinical Severity Score (VCSS) at 12 Months
Description	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)
Time Frame	Baseline and 12 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Zilver Vena Venous Self-Expanding Stent
Arm/Group Description	Zilver® Vena™ Venous Stent in the treatment of symptomatic iliofemoral venous outflow obstruction.
Measure Participants	243
At baseline	8.0 (4.2)
Change from baseline at 12 months	-4.2 (0.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Zilver Vena Venous Self-Expanding Stent
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	p-value is adjusted for multiplicity.
	Method	pair t-test
	Comments	A paired t-test with p-values adjusted for multiple comparisons using the Holm's procedure to control for a family-wise Type I error rate of 0.05
Method of Estimation	Estimation Parameter	Change from Baseline Mean
	Estimated Value	-4.2
	Confidence Interval	(2-Sided) 95%; -4.7 to -3.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	3 year
Arm/Group Title	Zilver Vena Venous Stent
Arm/Group Description	Zilver Vena Venous Stent: stenting
All Cause Mortality
	Zilver Vena Venous Stent
	Affected / at Risk (%)	# Events
Total	5/243 (2.1%)
Serious Adverse Events
	Zilver Vena Venous Stent
	Affected / at Risk (%)	# Events
Total	111/243 (45.7%)
Blood and lymphatic system disorders
Anaemia	3/243 (1.2%)	3
Blood loss anaemia	1/243 (0.4%)	1
Disseminated intravascular coagulation	1/243 (0.4%)	2
Cardiac disorders
Angina pectoris	2/243 (0.8%)	3
Aortic valve incompetence	1/243 (0.4%)	1
Arrhythmia	3/243 (1.2%)	3
Atrial fibrillation	1/243 (0.4%)	1
Cardiac failure	1/243 (0.4%)	1
Cardiac failure acute	1/243 (0.4%)	1
Cardiac failure congestive	2/243 (0.8%)	3
Cardiogenic shock	1/243 (0.4%)	1
Coronary artery disease	1/243 (0.4%)	1
Myocardial infarction	2/243 (0.8%)	2
Tachycardia	1/243 (0.4%)	1
Endocrine disorders
Goiter	1/243 (0.4%)	1
Eye disorders
Corneal degeneration	1/243 (0.4%)	2
Orbital haemorrhage	1/243 (0.4%)	1
Gastrointestinal disorders
Abdominal mass	1/243 (0.4%)	1
Abdominal pain	5/243 (2.1%)	8
Constipation	1/243 (0.4%)	1
Diarrhoea	2/243 (0.8%)	2
Gastrointestinal haemorrhage	1/243 (0.4%)	1
Intestinal fistula	1/243 (0.4%)	1
Nausea	3/243 (1.2%)	4
Rectal obstruction	1/243 (0.4%)	1
Small intestinal obstruction	2/243 (0.8%)	6
Vomiting	2/243 (0.8%)	2
General disorders
Chest pain	3/243 (1.2%)	3
Hernia	1/243 (0.4%)	1
Nodule	1/243 (0.4%)	1
Non-cardiac chest pain	1/243 (0.4%)	1
Oedema	1/243 (0.4%)	1
Pain	1/243 (0.4%)	1
Pelvic mass	1/243 (0.4%)	1
Peripheral swelling	1/243 (0.4%)	1
Pyrexia	2/243 (0.8%)	2
Surgical failure	1/243 (0.4%)	1
Ulcer	1/243 (0.4%)	1
Vascular stent occlusion	15/243 (6.2%)	17
Vascular stent restenosis	6/243 (2.5%)	8
Vascular stent stenosis	1/243 (0.4%)	1
Vascular stent thrombosis	6/243 (2.5%)	7
Hepatobiliary disorders
Cholelithiasis	1/243 (0.4%)	1
Infections and infestations
Babesiosis	1/243 (0.4%)	1
Bronchitis	1/243 (0.4%)	1
Cellulitis	5/243 (2.1%)	9
Chronic sinusitis	1/243 (0.4%)	1
Localised infection	1/243 (0.4%)	1
Meningitis	1/243 (0.4%)	1
Osteomyelitis	2/243 (0.8%)	2
Pelvic infection	1/243 (0.4%)	1
Perineal abscess	1/243 (0.4%)	1
Pharyngitis streptococcal	1/243 (0.4%)	1
Pneumonia	3/243 (1.2%)	3
Post procedural infection	1/243 (0.4%)	1
Sepsis	7/243 (2.9%)	11
Urinary tract infection	2/243 (0.8%)	3
Wound infection	2/243 (0.8%)	2
Injury, poisoning and procedural complications
Clavicle fracture	1/243 (0.4%)	1
Contusion	1/243 (0.4%)	1
Fall	4/243 (1.6%)	6
Femur fracture	1/243 (0.4%)	1
Hip fracture	2/243 (0.8%)	2
Humerus fracture	3/243 (1.2%)	3
Injury	1/243 (0.4%)	1
Limb traumatic amputation	1/243 (0.4%)	1
Overdose	1/243 (0.4%)	1
Pelvic fracture	1/243 (0.4%)	1
Radius fracture	1/243 (0.4%)	1
Rib fracture	2/243 (0.8%)	2
Tendon rupture	1/243 (0.4%)	1
Thoracic vertebral fracture	1/243 (0.4%)	1
Traumatic liver injury	1/243 (0.4%)	1
Ulna fracture	1/243 (0.4%)	1
Vascular access site haematoma	1/243 (0.4%)	1
Investigations
Blood bilirubin increased	1/243 (0.4%)	1
Blood glucose increased	1/243 (0.4%)	1
Blood magnesium decreased	1/243 (0.4%)	1
Blood pressure decreased	1/243 (0.4%)	1
Coagulation time prolonged	15/243 (6.2%)	16
Hepatic enzyme increased	1/243 (0.4%)	1
Liver function test increased	1/243 (0.4%)	1
Metabolism and nutrition disorders
Dehydration	2/243 (0.8%)	2
Hyperglycemia	1/243 (0.4%)	1
Hypokalemia	2/243 (0.8%)	2
Hypomagnesaemia	1/243 (0.4%)	1
Malnutrition	1/243 (0.4%)	1
Metabolic acidosis	1/243 (0.4%)	1
Musculoskeletal and connective tissue disorders
Arthralgia	3/243 (1.2%)	3
Back pain	3/243 (1.2%)	3
Cervical spinal stenosis	1/243 (0.4%)	1
Fracture nonunion	1/243 (0.4%)	1
Intervertebral disc protusion	3/243 (1.2%)	3
Lumbar spinal stenosis	1/243 (0.4%)	1
Musculoskeletal chest pain	1/243 (0.4%)	1
Osteoarthritis	5/243 (2.1%)	7
Pain in extremity	3/243 (1.2%)	3
Spinal stenosis	1/243 (0.4%)	1
Spondylolisthesis	1/243 (0.4%)	1
Trigger finger	1/243 (0.4%)	1
Vertebral foraminal stenosis	1/243 (0.4%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukemia	1/243 (0.4%)	1
Acute myeloid leukemia	1/243 (0.4%)	1
Angiomyolipoma	1/243 (0.4%)	1
Bladder cancer	2/243 (0.8%)	2
Brain neoplasm	1/243 (0.4%)	1
Intraductal proliferative breast lesion	1/243 (0.4%)	1
Metastatic squamous cell carcinoma	1/243 (0.4%)	1
Pancreatic carcinoma metastatic	1/243 (0.4%)	1
Transitional cell carcinoma	1/243 (0.4%)	1
Uterine leiomyoma	2/243 (0.8%)	2
Nervous system disorders
Cerebrovascular accident	1/243 (0.4%)	1
Lumbar radiculopathy	1/243 (0.4%)	1
Metabolic encephalopathy	1/243 (0.4%)	1
Migraine	1/243 (0.4%)	1
Myastenia gravis	1/243 (0.4%)	1
Myoclonus	1/243 (0.4%)	1
Sciatica	1/243 (0.4%)	1
Spinal claudication	1/243 (0.4%)	1
Syncope	1/243 (0.4%)	1
Transient ischemic attack	3/243 (1.2%)	3
Pregnancy, puerperium and perinatal conditions
Pregnancy	1/243 (0.4%)	1
Product Issues
Device dislocation	1/243 (0.4%)	1
Psychiatric disorders
Depression	2/243 (0.8%)	2
Suicidal ideation	1/243 (0.4%)	1
Renal and urinary disorders
Acute kidney injury	4/243 (1.6%)	4
Calculus bladder	1/243 (0.4%)	1
Haematuria	1/243 (0.4%)	1
Hydronephrosis	1/243 (0.4%)	1
Nephrolithiasis	2/243 (0.8%)	2
Renal failure	1/243 (0.4%)	1
Ureteric obstruction	1/243 (0.4%)	1
Urinary retention	2/243 (0.8%)	2
Urinary tract obstruction	1/243 (0.4%)	1
Reproductive system and breast disorders
Adnexal torsion	1/243 (0.4%)	1
Endometrial hyperplasia	1/243 (0.4%)	1
Female genital tract fistula	1/243 (0.4%)	1
Menometrorrhagia	1/243 (0.4%)	1
Menorrhagia	1/243 (0.4%)	1
Ovarian cyst	2/243 (0.8%)	2
Pelvic haematoma	1/243 (0.4%)	1
Pelvic prolapse	1/243 (0.4%)	1
Uterine polyp	1/243 (0.4%)	1
Uterine prolapse	1/243 (0.4%)	1
Vaginal haemorrhage	1/243 (0.4%)	1
Vulvovaginal pain	1/243 (0.4%)	1
Respiratory, thoracic and mediastinal disorders
Dyspnoea	4/243 (1.6%)	5
Hypoxia	1/243 (0.4%)	1
Pleural effusion	1/243 (0.4%)	1
Pneumonia aspiration	1/243 (0.4%)	1
Pneumothorax	1/243 (0.4%)	1
Pulmonary embolism	7/243 (2.9%)	8
Pulmonary oedema	1/243 (0.4%)	1
Respiratory failure	4/243 (1.6%)	4
Skin and subcutaneous tissue disorders
Diabetic foot	1/243 (0.4%)	1
Diabetic wound	1/243 (0.4%)	1
Skin ulcer	2/243 (0.8%)	3
Surgical and medical procedures
Cholecystectomy	1/243 (0.4%)	1
Colostomy	1/243 (0.4%)	1
Faecal management	1/243 (0.4%)	1
Metabolic surgery	1/243 (0.4%)	1
Vascular disorders
Aortic aneurysm	1/243 (0.4%)	1
Arterial occlusive disease	1/243 (0.4%)	1
Deep vein thrombosis	5/243 (2.1%)	5
Embolism	1/243 (0.4%)	3
Femoral artery aneurysm	1/243 (0.4%)	1
Haemorrhage	15/243 (6.2%)	16
Hypertension	2/243 (0.8%)	2
Iliac vein stenosis	1/243 (0.4%)	1
Intermittent claudication	1/243 (0.4%)	1
May-Thurner syndrome	1/243 (0.4%)	1
Orthostatic hypotension	1/243 (0.4%)	1
Peripheral embolism	1/243 (0.4%)	1
Vascular occlusion	1/243 (0.4%)	1
Vascular wall hypertrophy	1/243 (0.4%)	1
Vena cava thrombosis	1/243 (0.4%)	1
Venous occlusion	1/243 (0.4%)	1
Other (Not Including Serious) Adverse Events
	Zilver Vena Venous Stent
	Affected / at Risk (%)	# Events
Total	84/243 (34.6%)
General disorders
Peripheral swelling	13/243 (5.3%)	13
Vascular stent occlusion	14/243 (5.8%)	15
Investigations
Coagulation time prolonged	27/243 (11.1%)	32
Musculoskeletal and connective tissue disorders
Pain in extremity	25/243 (10.3%)	27
Vascular disorders
Haemorrhage	28/243 (11.5%)	33
Peripheral venous disease	19/243 (7.8%)	36

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.