A Study To Evaluate The Veniti Vici™ Venous Stent System In Patients With A Chronic Iliofemoral Venous Outflow Obstruction
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 16-000941
NCT ID: NCT02112877
Sponsor Protocol Number: STE-HUM-007P
About this study
The purpose of this study is to evaluate the safety and effectiveness of the Veniti Vici™ Venous Stent System in relation to pre-defined objective performance goals when used to treat a chronic non-cancerous blockage of the iliofemoral vein.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Pre-procedure criteria
- Age ≥ 18 years
- Willing and capable of complying with all follow-up evaluations at the specified times
- Able and willing to provide written informed consent prior to study-specific procedures
- Has a unilateral, clinically significant, chronic non-malignant obstruction of the common femoral vein, external iliac vein, common iliac vein, or any combination thereof, defined as a ≥50% reduction in target vessel lumen diameter (to be measured by venogram during procedure)
- Has clinically significant venous obstruction defined as meeting at least one of the following clinical indicators
- Clinical severity class of CEAP classification ≥3
- VCSS Pain Score ≥2
- Negative pregnancy test in females of child-bearing potential
- Intention to stent the target lesion only with the Veniti Vici Venous Stent
Exclusion Criteria
- Pre-procedure criteria
- Has the presence or history of clinically significant pulmonary emboli within 6 months prior to enrollment
- Venous obstruction that extends into the inferior vena cava
- Contralateral disease of the common femoral vein, external iliac vein, common iliac vein, or any combination thereof with planned treatment within 30 days after subject enrollment
- Life expectancy <12 months
- Female of childbearing potential who is pregnant or plans to become pregnant during the duration of the clinical study
- Has uncontrolled or active coagulopathy
- Has known, uncorrectable bleeding diathesis with the following definitions
- Uncorrected INR ≥2.0 or aPTT ≥1.5 X normal local lab value
- Platelet count <80,000
- Uncorrected hemoglobin of ≤ 9 g/dL
- Has an estimated glomerular filtration rate (eGFR) <30 mL/min
- In patients with diabetes mellitus, eGFR <45 mL/min
- Has known hypersensitivity to nickel or titanium
- Has a contrast agent allergy that cannot be managed adequately with pre-medication
- Will have intended concurrent thrombolysis or thrombectomy procedure
- Will have intended or planned (within 30 days) adjuvant procedure such as creation of temporary arteriovenous fistula, placement of IVC filter, endovenectomy or saphenous vein ablation
- Has current or recent (within 30 days) active participation in another drug or device clinical trial
- Participation in observational studies is acceptable
- Is judged to be a poor candidate by the primary investigator
- Has had any prior surgical or endovascular procedure of the target vessel
- Catheter-directed or mechanical thrombolysis in the target vessel for DVT at least 3 month (90 days) prior to the VIRTUS index procedure is acceptable
- Intra-Procedural Criteria
- The lesions cannot be traversed with a guide wire
- The obstruction extends into the inferior vena cava or below the level of the lesser trochanter
- Vein diameters are not within limits stated in current Instructions for use as determined by venogram
- Do not meet the venogram binary stenosis definition, as determined by the treating physician
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Haraldur Bjarnason, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available