Back to resultsBARD® The VENOVO™ Venous Stent Study for Treatment of Iliofemoral Occlusive Disease (VERNACULAR)
Primary Purpose
May-Thurner Syndrome, Peripheral Vascular Disease, Venous Disease
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
VENOVO™ Venous Stent
Sponsored by
About this trial
This is an interventional treatment trial for May-Thurner Syndrome focused on measuring Vernacular, Iliofemoral Occlusive Disease
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- Vascular Breakthroughs, LLC
- Yale University
- Midwest Cardiovascular Research Foundation
- Metro Health Hospital
- Cox Medical Centers
- Mount Sinai Medical Center
- North Carolina Heart and Vascular
- Cardiothoracic and Vascular Surgeons
- Centra Health, Inc., dba Stroobants Cardiovascular Center
- Sentara Medical Group
- Lake Washington Vascular, PLLC
- CAMC Health Education and Research Institute
- Royal Prince Alfred Hospital
- JMLS Medical Services PTY LTDT/A PERTH INST. of VASCULAR RESEARCH
- Uniklinik RWTH
- Klinikum Arnberg
- Universitaets-Herrzentrum Freiburg-Bad Krozingen
- University Hospital Galway
- MUMC Maastricht
- Fundacion de investigacion HM Hospitales
- Guy's & St. Thomas' Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
VENOVO™ Venous Stent.
Arm Description
Implant of the VENOVO™ Venous Stent
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02655887
Brief Title
BARD® The VENOVO™ Venous Stent Study for Treatment of Iliofemoral Occlusive Disease
Acronym
VERNACULAR
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)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
June 15, 2016 (Actual)
Primary Completion Date
June 19, 2018 (Actual)
Study Completion Date
October 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
C. R. Bard
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
May-Thurner Syndrome, Peripheral Vascular Disease, Venous Disease, Iliofemoral Occlusive Disease
Keywords
Vernacular, Iliofemoral Occlusive Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
170 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VENOVO™ Venous Stent.
Arm Type
Experimental
Arm Description
Implant of the VENOVO™ Venous Stent
Intervention Type
Device
Intervention Name(s)
VENOVO™ Venous Stent
Intervention Description
VENOVO™ Venous stent placement
Primary Outcome Measure Information:
Title
Number of Participants With Primary Patency of the Venous Stent at 12 Months Post-Index Procedure
Description
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.
Time Frame
12 months post-index procedure
Title
Number of Participants With Freedom From Major Adverse Events (MAEs)
Description
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.
Time Frame
30 days post-index procedure
Secondary Outcome Measure Information:
Title
Endpoint With Hypothesis Testing: Index of Venous Clinical Severity Score (VCSS) From Baseline to 12 Months
Description
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.
Time Frame
Evaluation at 12 months post-index procedure
Title
Endpoint With Hypothesis Testing: Index of Quality of Life (QoL) From Baseline to 12 Months
Description
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.
Time Frame
Evaluation at 12 months post-index procedure
Title
Endpoint Without Hypothesis Testing: Index of CEAP at 30 Days, 6 Months, and 12 Months Post Procedure
Description
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.
Time Frame
Evaluation through 30 day, 6 months and 12 months post index procedure
Title
Endpoint Without Hypothesis Testing: Number of Participants With Acute Technical Success
Description
Acute technical success is defined as successful deployment of stent(s) to intended target with adequate lesion coverage as assessed by the Investigator.
Time Frame
At time of Index Procedure
Title
Endpoint Without Hypothesis Testing: Number of Participants With Acute Procedure Success (ITT Subjects)
Description
Technical success is defined as no major adverse events experienced between index procedure and discharge
Time Frame
Less than 30 days post index procedure
Title
Endpoint Without Hypothesis Testing: Number of Participants With Lesion Success (ITT Subjects)
Description
Lesion Success is defined as the attainment of less or equal to 50% residual stenosis at the conclusion of the index procedure.
Time Frame
At the conclusion of index procedure
Title
Endpoint Without Hypothesis Testing: Number of Participants With Freedom From Target Lesion Revascularization (TLR) (ITT Subjects)
Description
Freedom from Target Lesion Revascularization (TLR) through 30 days is specific to the first revascularization procedure of the target lesion.
Time Frame
Evaluation throrugh 30 day, 6 months and 12 months post index procedure
Title
Endpoint Without Hypothesis Testing: Number of Participants With Freedom From Target Vessel Revascularization (TVR) (ITT Subjects)
Description
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.
Time Frame
Evaluation through 30 days, 6 months and 12 months post index procedure
Title
Endpoint Without Hypothesis Testing: Number of Participants Without Device Stent Fracture at 12 Months Follow-Up
Description
Stents were evaluated at the 12 month follow-up for fracture analysis. Evaluable ITT subjects are included in this analysis.
Time Frame
Evaluation at 12 months post-index procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Dake, MD
Organizational Affiliation
Lead Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vascular Breakthroughs, LLC
City
Darien
State/Province
Connecticut
ZIP/Postal Code
06820
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Midwest Cardiovascular Research Foundation
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52803
Country
United States
Facility Name
Metro Health Hospital
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Facility Name
Cox Medical Centers
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
North Carolina Heart and Vascular
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Cardiothoracic and Vascular Surgeons
City
Austin
State/Province
Texas
ZIP/Postal Code
78746
Country
United States
Facility Name
Centra Health, Inc., dba Stroobants Cardiovascular Center
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
Facility Name
Sentara Medical Group
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23542
Country
United States
Facility Name
Lake Washington Vascular, PLLC
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
CAMC Health Education and Research Institute
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
JMLS Medical Services PTY LTDT/A PERTH INST. of VASCULAR RESEARCH
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Uniklinik RWTH
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Klinikum Arnberg
City
Arnsberg
ZIP/Postal Code
59755
Country
Germany
Facility Name
Universitaets-Herrzentrum Freiburg-Bad Krozingen
City
Bad Krozingen
ZIP/Postal Code
79189
Country
Germany
Facility Name
University Hospital Galway
City
Gaillimh
ZIP/Postal Code
H91 YR71
Country
Ireland
Facility Name
MUMC Maastricht
City
Maastricht
ZIP/Postal Code
6202 AZ
Country
Netherlands
Facility Name
Fundacion de investigacion HM Hospitales
City
Madrid
ZIP/Postal Code
28660
Country
Spain
Facility Name
Guy's & St. Thomas' Hospital
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34545448
Citation
Dake 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. Erratum In: Cardiovasc Intervent Radiol. 2021 Oct 19;:
Results Reference
derived
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BARD® The VENOVO™ Venous Stent Study for Treatment of Iliofemoral Occlusive Disease
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