VIRTUS: An Evaluation of the Vici™ Venous Stent System in Patients With Chronic Iliofemoral Venous Outflow Obstruction



Status:Active, not recruiting
Healthy:No
Age Range:18 - Any
Updated:12/21/2018
Start Date:June 26, 2014
End Date:January 2022

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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

This is a prospective, multi-center, single arm, non-randomized study to define safety and
efficacy of the Veniti Vici™ Venous Stent System in relation to pre-defined Objective
Performance goals. A maximum of 200 patients at up to 45 centers worldwide will be enrolled.
Thirty (30) feasibility patients will be enrolled at approximately 7-10 centers and 170
pivotal patients will be enrolled at approximately 45 centers worldwide. The follow-up period
is 60 months.

The objective of this prospective study is to assess the safety and efficacy of the Veniti
Vici™ Venous Stent System in achieving patency of the target venous lesion in patients who
present with clinically significant chronic non-malignant obstruction of the iliofemoral
venous outflow tract.

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

- Presence of 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)

- 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:

- Presence or history of clinically significant pulmonary emboli within 6 months prior
to enrollment.

- Venous obstruction that extends into the inferior vena cava (IVC)

- 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

- Uncontrolled or active coagulopathy OR 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

- Patients with an estimated glomerular filtration rate (eGFR) <30 mL/min. In patients
with diabetes mellitus, eGFR <45 mL/min.

- Known hypersensitivity to nickel or titanium

- Contrast agent allergy that cannot be managed adequately with pre-medication

- Intended concurrent thrombolysis or thrombectomy procedure OR intended or planned
(within 30 days) adjuvant procedure such as creation of temporary arteriovenous
fistula, placement of IVC filter, endovenectomy or saphenous vein ablation

- Current or recent (within 30 days) active participation in another drug or device
clinical trial (Participation in observational studies is acceptable.)

- Patient judged to be a poor candidate by the primary investigator

- Patients who have had any prior surgical or endovascular intervention of the target
vessel [Note: Patients who have had catheter-directed or mechanical thrombolysis in
the target vessel for DVT at least 3 month (90 days) prior to the VIRTUS index
procedure may be included in the trial.]

Exclusion Criteria - Intra-Procedural Criteria:

- Patients in whom the lesions cannot be traversed with a guide wire.

- Patients where the obstruction extends into the inferior vena cava or below the level
of the lesser trochanter.

- Patients whose vein diameters are not within limits stated in current Instructions for
Use as determined by venogram.

- Patients who do not meet the venogram binary stenosis definition, as determined by the
treating physician.
We found this trial at
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Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Raghuveer Vallabhaneni, MD
Phone: 919-843-1279
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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Darien, Connecticut 06820
Principal Investigator: Paul Gagne, MD
Phone: 203-912-3227
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1622 East Lombard Street
Davenport, Iowa 52803
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1139 Caper Road
El Paso, Texas 79925
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Englewood, Colorado 80112
Principal Investigator: Brooke Spencer, MD
Phone: 720-493-3403
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Flint, Michigan 98507
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Lake Charles, Louisiana 70601
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Little Rock, Arkansas 72211
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3 Chemin du Penthod
Lyon, 69300
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New York, New York 10065
Principal Investigator: Ronald Wikenor, MD
Phone: 212-746-9748
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New York, New York 10016
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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Norfolk, Virginia 23507
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Orange, California 92868
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Phoenix, Arizona 85006
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Scottsdale, Arizona
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1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
Principal Investigator: Mark Meissner, MD
Phone: 206-221-7833
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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