Symptomatic Venous Outflow Obstruction in the Iliofemoral Vein
Conditions
Keywords
venous, outflow obstruction, iliofemoral vein
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.
Interventions
DEVICEZilver Vena Venous Self-Expanding Stent
stenting
Sponsors
Cook Research Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
Countries
Taiwan, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Zilver Vena Venous Self-Expanding Stent Zilver® Vena™ Venous Stent in the treatment of symptomatic iliofemoral venous outflow obstruction. | 243 |
| Total | 243 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 5 |
| Overall Study | Lost to Follow-up | 24 |
| Overall Study | Other endpoint | 3 |
| Overall Study | Withdrawal by Subject | 23 |
Baseline characteristics
| Characteristic | Zilver Vena Venous Self-Expanding Stent |
|---|---|
| Age, Continuous | 53.0 Years STANDARD_DEVIATION 15.3 |
| Race/Ethnicity, Customized Asian | 8 Participants |
| Race/Ethnicity, Customized Black or African American | 29 Participants |
| Race/Ethnicity, Customized First Nations / White | 1 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 7 Participants |
| Race/Ethnicity, Customized White | 198 Participants |
| Sex: Female, Male Female | 170 Participants |
| Sex: Female, Male Male | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 5 / 243 |
| other Total, other adverse events | 84 / 243 |
| serious Total, serious adverse events | 111 / 243 |
Outcome results
Primary
Number of Participants With 30-day Freedom From Major Adverse Events
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
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zilver Vena Venous Self-Expanding Stent | Number of Participants With 30-day Freedom From Major Adverse Events | 232 Participants |
p-value: <0.000195% CI: [93.5, 98.6]One-sided Exact binomial test
Primary
The Rate of Participants With Primary Quantitative Patency at 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.
Time frame: 12 months
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Zilver Vena Venous Self-Expanding Stent | The Rate of Participants With Primary Quantitative Patency at 12 Months | 89.9 percentage of participants |
p-value: <0.000195% CI: [85.1, 93.4]Binomial test for one proportion
Secondary
Change From Baseline in the Venous Clinical Severity Score (VCSS) 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)
Time frame: Baseline and 12 months
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Zilver Vena Venous Self-Expanding Stent | 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 |
| Zilver Vena Venous Self-Expanding Stent | 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 |
p-value: <0.000195% CI: [-4.7, -3.7]pair t-test
Secondary
Change From Baseline in the Venous Clinical Severity Score (VCSS) 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)
Time frame: Baseline and 1 month
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Zilver Vena Venous Self-Expanding Stent | 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 |
| Zilver Vena Venous Self-Expanding Stent | 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 |
p-value: <0.000195% CI: [-3.5, -2.6]paired t-test