VIRTUS: An Evaluation of the Vici™ Venous Stent System in Patients With Chronic Iliofemoral Venous Outflow Obstruction (VIRTUS)
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|ClinicalTrials.gov Identifier: NCT02112877|
Recruitment Status : Active, not recruiting
First Posted : April 14, 2014
Last Update Posted : November 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Venous Disorder Venous Outflow Obstruction Symptomatic Venous Outflow Obstruction of Iliofemoral Vein||Device: Veniti Vici™ Venous Stent System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||VIRTUS Safety and Efficacy of the Veniti Vici™ Venous Stent System (Veniti, Inc.) When Used to Treat Clinically Significant Chronic Non-malignant Obstruction of the Iliofemoral Venous Segment|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||December 5, 2017|
|Estimated Study Completion Date :||January 2022|
Experimental: Veniti Vici™ Venous Stent System
Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein
Device: Veniti Vici™ Venous Stent System
- Rate of Major Adverse Events (MAE) [ Time Frame: 30 days ]The primary safety endpoint for this study will be a composite endpoint of any major adverse event (MAE) within 30 days, as adjudicated by a Clinical Events Committee.
- Rate of Primary Patency [ Time Frame: 12 months post-intervention ]The primary effectiveness endpoint is the primary patency rate at 12 months post-intervention, defined as freedom from occlusion by thrombosis, freedom from surgical or endovascular intervention on target vessel which are found to have re-stenosis or stent occlusion to maintain patency, and freedom from in-stent stenosis more than 50% by venogram.
- Improvement in Venous Clinical Severity Score (VCSS) [ Time Frame: 12 months post-intervention ]The secondary effectiveness endpoint for this study will be a binary response variable based on an improvement in Venous Clinical Severity Score (VCSS) by at least 50% at 12 months post-intervention. VCSS measures 9 clinical attributes of venous disease (Pain, Varicose Veins, Venous Edema, Skin Pigmentation, Inflammation, Induration, No. Active Ulcers, Active Ulcer Size, Ulcer Duration and Compression Therapy) on a scale of 0 - 3 (Absent 0, Mild 1, Moderate 2, and Severe 3).
- Number of Participants with Procedural Technical Success [ Time Frame: During Procedure ]Procedural technical success is achievement of a final residual target vessel diameter stenosis of ≤50% as measured on the post procedural venogram, without skipped lesion regions, with placement of the study device alone with or without post-stenting balloon dilation as needed.
- Number of Treated Lesions with Lesion Success [ Time Frame: During Procedure ]Lesion success is defined as achievement of ≤50% residual diameter stenosis of the target lesion using any percutaneous method (including the use of non-study devices).
- Number of Participants with Procedural Success [ Time Frame: From the time of the Index Procedure post procedural venogram through the time of Index Procedure Discharge or 3 days Post-Procedure (whichever comes first) ]Procedural success is defined as procedural technical success without the occurrence of a major adverse event (MAE) between the index procedure and discharge.
- Number of Participants with Late Technical Success [ Time Frame: 12 months post-intervention ]Late technical success (through 12 months) is the absence of device movement >10mm related to anatomical landmarks or any migration leading to symptoms or requiring therapy; absence of stent occlusion by thrombosis or restenosis, defined as reduction in treated segment lumen more than 50% from the post-procedure vessel lumen diameter as measured by post-procedural venogram or DUS and maintenance of structural integrity, defined as the absence of pinching (focal compression), kinking (stent doubling or bending upon itself) that results in >50% diameter reduction of the stent, recoil (poor radial resistive force) or absence of fractures .
- Change in the Quality of Life (Chronic Venous Insufficiency Questionnaire)(CIVIQ2)) [ Time Frame: 12 months post-intervention ]The overall change in CIVIQ2 scores for the study patients, calculated using the area under the curve and presented with mean and 95% confidence intervals.
- Rate of Estimated Primary Patency [ Time Frame: 12 months post-intervention ]Primary-assisted patency is defined as freedom from occlusion regardless of whether an intervention (subsequent to the index procedure) was performed.
- Rate of Estimated Secondary Patency [ Time Frame: 60 months post-intervention ]Secondary patency is defined as freedom from "permanent" loss of patency determined through last follow-up (irrespective of the number of interventions).
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): NCT02112877
Show 24 Study Locations
|Principal Investigator:||William Marston, MD||UNC Department of Surgery|
|Principal Investigator:||Mahmood Razavi, MD||Vascular and Interventional Specialists of Orange County|