VIVO Clinical Study
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| ClinicalTrials.gov Identifier: NCT01970007 |
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Recruitment Status :
Completed
First Posted : October 25, 2013
Results First Posted : April 8, 2021
Last Update Posted : April 8, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Symptomatic Venous Outflow Obstruction in the Iliofemoral Vein | Device: Zilver Vena Venous Self-Expanding Stent | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| 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 : | December 13, 2013 |
| Actual Primary Completion Date : | November 20, 2017 |
| Actual Study Completion Date : | November 20, 2019 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Zilver Vena Venous Self-Expanding Stent |
Device: Zilver Vena Venous Self-Expanding Stent
stenting
Other Name: venous stent |
- Number of Participants With 30-day Freedom From Major Adverse Events [ Time Frame: 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 [ Time Frame: 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.
- Change From Baseline in the Venous Clinical Severity Score (VCSS) at 1 Month [ Time Frame: 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 [ Time Frame: 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)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01970007
Show 30 study locations
| Principal Investigator: | Anthony J. Comerota, MD, FACS, FACC | Inova Vascular | |
| Principal Investigator: | Lawrence "Rusty" Hofmann, MD | Stanford University |
Documents provided by Cook Group Incorporated ( Cook Research Incorporated ):
| Responsible Party: | Cook Research Incorporated |
| ClinicalTrials.gov Identifier: | NCT01970007 |
| Other Study ID Numbers: |
11-010 |
| First Posted: | October 25, 2013 Key Record Dates |
| Results First Posted: | April 8, 2021 |
| Last Update Posted: | April 8, 2021 |
| Last Verified: | March 2021 |
|
venous outflow obstruction iliofemoral vein |