May-Thurner SyndromeVERNACULARNCT02655887
BARD® The VENOVO™ Venous Stent Study for Treatment of Iliofemoral Occlusive Disease
A study testing VENOVO™ Venous Stent in people with May-Thurner Syndrome and Peripheral Vascular Disease, run by C. R. Bard at 21 sites in 7 countries.
Trial summary
The BARD® Venovo™ Venous Stent Study is a non-randomized clinical study intended to collect confirmatory evidence of the safety and effectiveness of the Venous Stent for the treatment of iliofemoral occlusive disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- May-Thurner Syndrome, Peripheral Vascular Disease, Venous Disease
- What is being tested?
- VENOVO™ Venous Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 21 sitesin 7 countries
- Study dates
- 15 Jun 2016to 30 Oct 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject provides written informed consent using an Informed Consent Form approved by Ethics Committee/ Institutional Review Board for the site.
- Subject agrees to comply with the protocol-mandated follow-up procedures and visits.
- The subject is a male or non-pregnant female ≥ 18 years old with an expected lifespan sufficient to allow for completion of all study procedures.
- The subject has symptomatic (non-malignant) venous outflow obstruction in iliofemoral "venous segments".
- The subject has symptomatic venous outflow obstruction (non-malignant) in iliofemoral venous segments(Clinical-Etiology-Anatomic-Pathophysiologic (CEAP) "C" ≥ 3 or VCSS pain score of ≥ 2).
- The subject is able and willing to comply with any required medication regimen.
- The reference vessel diameters are between 7mm and 19 mm.
Who cannot join
- Subject is unable or unwilling to provide written informed consent, or is unable or unwilling to conform to the study protocol follow-up procedures and visits.
- Subject is or plans to become pregnant during the study.
- Subject has contralateral disease of the common femoral vein, external iliac vein, common iliac vein, or any combination thereof and does not meet the venous outflow obstruction requirement or has a malignant obstruction.
- The subject is asymptomatic, has a CEAP "C" <3, or a VCSS pain score of <2.
- The subject has a venous obstruction that extends into the inferior vena cava (IVC) or below the level of the lesser trochanter.
- The subject has a known uncorrectable bleeding diathesis or active coagulopathy.
Show all 15Show fewer
- The subject has a known allergy or sensitivity to Nickel or Titanium or intolerance to antiplatelet, anticoagulant or thrombolytic medications medications required per the protocol
- The subject has a known allergy or sensitivity to contrast media, which cannot be adequately pre-medicated.
- The subject has any planned surgical interventions within 30 days prior to, or within 30 days after the planned study procedure.
- The subject has a lesion or occlusion which cannot be traversed with a guidewire.
- The subject has had prior stenting in the target vessel.
- The subject has iliofemoral venous segments unsuitable for treatment with available sizes of study devices.
- The subject has another medical condition, which may cause him/her to be non-compliant with the protocol, confound the data interpretation, or is associated with a life expectancy insufficient to allow completion of study procedures and follow ups.
- The subject is currently participating in an investigational drug, biologic, or another device study.
- The subject is currently on dialysis or has a serum creatinine ≥2.5mg/dl.
Trial locations and contacts
21 sites in 7 countries.
21 sites in 7 countries
United States12 sites
Cardiothoracic and Vascular Surgeons
Austin, Texas, 78746
Lake Washington Vascular, PLLC
Bellevue, Washington, 98004
CAMC Health Education and Research Institute
Charleston, West Virginia, 25304
Vascular Breakthroughs, LLC
Darien, Connecticut, 06820
Midwest Cardiovascular Research Foundation
Davenport, Iowa, 52803
Centra Health, Inc., dba Stroobants Cardiovascular Center
Lynchburg, Virginia, 24501
Yale University
New Haven, Connecticut, 06520
Mount Sinai Medical Center
New York, New York, 10029
North Carolina Heart and Vascular
Raleigh, North Carolina, 27607
Cox Medical Centers
Springfield, Missouri, 65807
Sentara Medical Group
Virginia Beach, Virginia, 23542
Metro Health Hospital
Wyoming, Michigan, 49519
Germany3 sites
Uniklinik RWTH
Aachen, 52074
Klinikum Arnberg
Arnsberg, 59755
Universitaets-Herrzentrum Freiburg-Bad Krozingen
Bad Krozingen, 79189
Australia2 sites
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
JMLS Medical Services PTY LTDT/A PERTH INST. of VASCULAR RESEARCH
Perth, Western Australia, 6009
About this study
Official title: The BARD® VENOVO™ Venous Stent Study - A Prospective, Non-Randomized, Multi-Center, Single-Arm Study of the Treatment of Iliofemoral Occlusive Disease - an Assessment for Effectiveness and Safety (VERNACULAR)
The BARD® Venovo™ Venous Stent Study is a non-randomized clinical study intended to collect confirmatory evidence of the safety and effectiveness of the Venous Stent for the treatment of iliofemoral occlusive disease.
Read the detailed description
This is a prospective, multi-center, non-randomized, single-arm clinical study of the VENOVO ™ Venous Stent for the treatment of iliofemoral occlusive disease. The study will be conducted at a maximum of 35 investigational sites ("sites") in the United States, and Europe and Australia/New Zealand. Enrollment will continue until a maximum of one hundred seventy (170) subjects are treated with the VENOVO™ Venous Stent, which is an estimated three-hundred forty (340) consecutive subjects in a non-randomized fashion. It is assumed that approximately 50% of the treated subjects will be U.S. subjects. Clinical follow-up for all treated subjects will be performed at hospital discharge, 30-days, and 6-, 12-, 24-, and 36-months post-index procedure.
- Conditions
- May-Thurner Syndrome, Peripheral Vascular Disease, Venous Disease, Iliofemoral Occlusive Disease
- Being tested
- VENOVO™ Venous Stent
- Keywords
- Vernacular, Iliofemoral Occlusive Disease
- Medical subject headings
- May-Thurner Syndrome, Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VENOVO™ Venous StentDevice
VENOVO™ Venous stent placement
| Study group | Role | What they receive |
|---|---|---|
| VENOVO™ Venous Stent. | Experimental | Implant of the VENOVO™ Venous Stent Receives: Device: VENOVO™ Venous Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Primary Patency of the Venous Stent at 12 Months Post-Index Procedure
Primary patency rate at 12 months post-index procedure evaluated against a literature-derived Performance Goal (PG) of 74%. Primary patency defined as: freedom from Target Vessel Revascularization (TVR); freedom from thrombus occlusion and stenosis > 50% as measured by Duplex Ultrasound (DUS).
Please note that both the primary effectiveness and the primary safety endpoint are considered co-primary endpoints. That is, both endpoints need to be significant to claim the study as successful.
Measured: 12 months post-index procedure
Number of Participants With Freedom From Major Adverse Events (MAEs)
Freedom from major adverse events (MAEs) defined as: Target Vessel Revascularization; Device and/or procedure related death; Major amputation of target limb; Pulmonary Embolism which is clinically important; Vascular injury requiring surgical/endovascular intervention; Embolization /migration of stent; Device or procedure related acute DVT involving the treated limb.
Please note that both the primary effectiveness and the primary safety endpoint are considered co-primary endpoints. That is, both endpoints need to be significant to claim the study as successful.
Measured: 30 days post-index procedure
Secondary outcomes (9)
Endpoint With Hypothesis Testing: Index of Venous Clinical Severity Score (VCSS) From Baseline to 12 Months
The Venous Clinical Severity Score (VCSS) system includes 10 clinical descriptions (pain, varicose veins, venous edema, skin pigmentation, inflammation, induration, number of active ulcers, duration of active ulceration, size of active ulceration. and level of compliance with medical compression therapy), scored from 0 to 3 (total possible score, 30) with 0 means absent, 1 means mild, 2 means moderate and 3 means severe. Total VCSS is the sum of all VCSS assessment scores from categories for a given time point. Twelve-month data is the change between baseline score and 12-month follow-up score. Results calculated for Intent-to-Treat (ITT) subjects. Lower values represent a better outcome, that is, a level of pain less than that experienced at baseline.
Measured: Evaluation at 12 months post-index procedure
Endpoint With Hypothesis Testing: Index of Quality of Life (QoL) From Baseline to 12 Months
The Quality of Life (QoL) assessment of Chronic Venous Insufficiency Questionnaire (CIVIC-20) is a 20-item questionnaire which provides a global index and an outline of 4 QoL dimensions - pain (4 items), physical (4 items), psychological (9 items) and social (4 items). Items are scored on a scale from 1 to 5. A low score corresponds to greater patient comfort. Total CIVIQ-20 score is the sum of all 20-item scores The score of each dimension was obtained by adding up the scores of each constituent item within that dimension. Twelve-month data is the change between baseline score and 12-month follow-up score. Results calculated for evaluable ITT subjects. Lower values represent a better outcome, that is, a better QoL than that experienced at baseline.
Measured: Evaluation at 12 months post-index procedure
Endpoint Without Hypothesis Testing: Index of CEAP at 30 Days, 6 Months, and 12 Months Post Procedure
Clinical-Etiologic-Anatomic-Pathophysiologic (CEAP) Classification is a system that describes a doctor's physical exam findings for vein problem(s), the cause of the problem(s), the location in the leg, and the mechanism responsible for the manifestation of the vein problem. For Clinical classification, the clinical components indicates disease severity, ranging from none (0 points) to active ulcers (6 points).For each category of Etiology, Anatomy, and Pathophysiology classifications, at each time point, frequency of each category is reported. Subsequent clinical study reports will present CEAP at 24 and 36-months follow-up. Changes from baseline measures to given time points are presented. Lower mean scores represent an improvement from baseline measure.
Measured: Evaluation through 30 day, 6 months and 12 months post index procedure
Endpoint Without Hypothesis Testing: Number of Participants With Acute Technical Success
Acute technical success is defined as successful deployment of stent(s) to intended target with adequate lesion coverage as assessed by the Investigator.
Measured: At time of Index Procedure
Endpoint Without Hypothesis Testing: Number of Participants With Acute Procedure Success (ITT Subjects)
Technical success is defined as no major adverse events experienced between index procedure and discharge
Measured: Less than 30 days post index procedure
Endpoint Without Hypothesis Testing: Number of Participants With Lesion Success (ITT Subjects)
Lesion Success is defined as the attainment of less or equal to 50% residual stenosis at the conclusion of the index procedure.
Measured: At the conclusion of index procedure
Endpoint Without Hypothesis Testing: Number of Participants With Freedom From Target Lesion Revascularization (TLR) (ITT Subjects)
Freedom from Target Lesion Revascularization (TLR) through 30 days is specific to the first revascularization procedure of the target lesion.
Measured: Evaluation throrugh 30 day, 6 months and 12 months post index procedure
Endpoint Without Hypothesis Testing: Number of Participants With Freedom From Target Vessel Revascularization (TVR) (ITT Subjects)
Freedom from Target Vessel Revascularization (TVR) is defined as the first revascularization procedure of the target vessel, as determined by an Independent Core Lab. Freedom from Target Lesion Revascularization (TLR) and Freedom from TVR results are the same through the 12 month analysis as all TLRs were also TVRs in this case.
Measured: Evaluation through 30 days, 6 months and 12 months post index procedure
Endpoint Without Hypothesis Testing: Number of Participants Without Device Stent Fracture at 12 Months Follow-Up
Stents were evaluated at the 12 month follow-up for fracture analysis. Evaluable ITT subjects are included in this analysis.
Measured: Evaluation at 12 months post-index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2016 (estimated)
- Study start15 Jun 2016
- Primary completion19 Jun 2018
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for May-Thurner SyndromeStudies of the same condition, open and under way.
- More trials run by C. R. BardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Dake, MD, Principal investigator, Lead Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02655887
- Sponsor's protocol ID
- BPV-14-007
- Acronym
- VERNACULAR
- Status last verified
- Jan 2021
- First submitted
- 7 Jan 2016
- Last updated
- 4 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Flumignan RL, Nakano LC, Flumignan CD, Baptista-Silva JC. Angioplasty or stenting for deep venous thrombosis. Cochrane Database Syst Rev. 2025 Feb 19;2(2):CD011468. doi: 10.1002/14651858.CD011468.pub2.
PubMed 39968829Dake MD, O'Sullivan G, Shammas NW, Lichtenberg M, Mwipatayi BP, Settlage RA; VERNACULAR Trial Investigators. Three-Year Results from the Venovo Venous Stent Study for the Treatment of Iliac and Femoral Vein Obstruction. Cardiovasc Intervent Radiol. 2021 Dec;44(12):1918-1929. doi: 10.1007/s00270-021-02975-2. Epub 2021 Sep 20.
PubMed 34545448
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The BARD® VENOVO™ Venous Stent Study - A Prospective, Non-Randomized, Multi-Center, Single-Arm Study of the Treatment of Iliofemoral Occlusive Disease - an Assessment for Effectiveness and Safety (VERNACULAR)
- ClinicalTrials.gov ID
- NCT02655887
- Acronym / sponsor ID
- VERNACULAR / BPV-14-007
- Conditions
- May-Thurner Syndrome, Peripheral Vascular Disease, Venous Disease, Iliofemoral Occlusive Disease
- Keywords
- Vernacular, Iliofemoral Occlusive Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Study start
- 15 Jun 2016 (actual)
- Primary completion
- 19 Jun 2018 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 14 Jan 2016 (estimated)
- Results
- Posted 12 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The BARD® Venovo™ Venous Stent Study is a non-randomized clinical study intended to collect confirmatory evidence of the safety and effectiveness of the Venous Stent for the treatment of iliofemoral occlusive disease.
Detailed description
This is a prospective, multi-center, non-randomized, single-arm clinical study of the VENOVO ™ Venous Stent for the treatment of iliofemoral occlusive disease. The study will be conducted at a maximum of 35 investigational sites ("sites") in the United States, and Europe and Australia/New Zealand. Enrollment will continue until a maximum of one hundred seventy (170) subjects are treated with the VENOVO™ Venous Stent, which is an estimated three-hundred forty (340) consecutive subjects in a non-randomized fashion. It is assumed that approximately 50% of the treated subjects will be U.S. subjects. Clinical follow-up for all treated subjects will be performed at hospital discharge, 30-days, and 6-, 12-, 24-, and 36-months post-index procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VENOVO™ Venous Stent. | Experimental | Device: VENOVO™ Venous StentImplant of the VENOVO™ Venous Stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The subject provides written informed consent using an Informed Consent Form approved by Ethics Committee/ Institutional Review Board for the site.
- Subject agrees to comply with the protocol-mandated follow-up procedures and visits.
- The subject is a male or non-pregnant female ≥ 18 years old with an expected lifespan sufficient to allow for completion of all study procedures.
- The subject has symptomatic (non-malignant) venous outflow obstruction in iliofemoral "venous segments".
- The subject has symptomatic venous outflow obstruction (non-malignant) in iliofemoral venous segments(Clinical-Etiology-Anatomic-Pathophysiologic (CEAP) "C" ≥ 3 or VCSS pain score of ≥ 2).
Key exclusion criteria (15 listed)
- Subject is unable or unwilling to provide written informed consent, or is unable or unwilling to conform to the study protocol follow-up procedures and visits.
- Subject is or plans to become pregnant during the study.
- Subject has contralateral disease of the common femoral vein, external iliac vein, common iliac vein, or any combination thereof and does not meet the venous outflow obstruction requirement or has a malignant obstruction.
- The subject is asymptomatic, has a CEAP "C" <3, or a VCSS pain score of <2.
- The subject has a venous obstruction that extends into the inferior vena cava (IVC) or below the level of the lesser trochanter.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VENOVO™ Venous StentVENOVO™ Venous stent placement | Device | VENOVO™ Venous Stent. |
Primary outcome
Number of Participants With Primary Patency of the Venous Stent at 12 Months Post-Index Procedure
Time frame: 12 months post-index procedure
Primary patency rate at 12 months post-index procedure evaluated against a literature-derived Performance Goal (PG) of 74%. Primary patency defined as: freedom from Target Vessel Revascularization (TVR); freedom from thrombus occlusion and stenosis > 50% as measured by Duplex Ultrasound (DUS). Please note that both the primary effectiveness and the primary safety endpoint are considered co-primary endpoints. That is, both endpoints need to be significant to claim the study as successful.
Number of Participants With Freedom From Major Adverse Events (MAEs)
Time frame: 30 days post-index procedure
Freedom from major adverse events (MAEs) defined as: Target Vessel Revascularization; Device and/or procedure related death; Major amputation of target limb; Pulmonary Embolism which is clinically important; Vascular injury requiring surgical/endovascular intervention; Embolization /migration of stent; Device or procedure related acute DVT involving the treated limb. Please note that both the primary effectiveness and the primary safety endpoint are considered co-primary endpoints. That is, both endpoints need to be significant to claim the study as successful.
9 secondary outcomes
Endpoint With Hypothesis Testing: Index of Venous Clinical Severity Score (VCSS) From Baseline to 12 Months
Time frame: Evaluation at 12 months post-index procedure
Endpoint With Hypothesis Testing: Index of Quality of Life (QoL) From Baseline to 12 Months
Time frame: Evaluation at 12 months post-index procedure
Endpoint Without Hypothesis Testing: Index of CEAP at 30 Days, 6 Months, and 12 Months Post Procedure
Time frame: Evaluation through 30 day, 6 months and 12 months post index procedure
Endpoint Without Hypothesis Testing: Number of Participants With Acute Technical Success
Time frame: At time of Index Procedure
Endpoint Without Hypothesis Testing: Number of Participants With Acute Procedure Success (ITT Subjects)
Time frame: Less than 30 days post index procedure
Endpoint Without Hypothesis Testing: Number of Participants With Lesion Success (ITT Subjects)
Time frame: At the conclusion of index procedure
Endpoint Without Hypothesis Testing: Number of Participants With Freedom From Target Lesion Revascularization (TLR) (ITT Subjects)
Time frame: Evaluation throrugh 30 day, 6 months and 12 months post index procedure
Endpoint Without Hypothesis Testing: Number of Participants With Freedom From Target Vessel Revascularization (TVR) (ITT Subjects)
Time frame: Evaluation through 30 days, 6 months and 12 months post index procedure
Endpoint Without Hypothesis Testing: Number of Participants Without Device Stent Fracture at 12 Months Follow-Up
Time frame: Evaluation at 12 months post-index procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39968829Flumignan RL, Nakano LC, Flumignan CD, Baptista-Silva JC. Angioplasty or stenting for deep venous thrombosis. Cochrane Database Syst Rev. 2025 Feb 19;2(2):CD011468. doi: 10.1002/14651858.CD011468.pub2.
- Derived from this study: PubMed 34545448Dake MD, O'Sullivan G, Shammas NW, Lichtenberg M, Mwipatayi BP, Settlage RA; VERNACULAR Trial Investigators. Three-Year Results from the Venovo Venous Stent Study for the Treatment of Iliac and Femoral Vein Obstruction. Cardiovasc Intervent Radiol. 2021 Dec;44(12):1918-1929. doi: 10.1007/s00270-021-02975-2. Epub 2021 Sep 20.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Dake, MD principal investigator
Lead Principal Investigator
21 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VENOVO™ Venous Stent in people with May-Thurner Syndrome and Peripheral Vascular Disease, run by C. R. Bard at 21 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Germany, Australia, Ireland, Netherlands and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Primary Patency of the Venous Stent at 12 Months Post-Index Procedure (time frame: 12 months post-index procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02655887, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.