VERNACULAR: BARD® The VENOVO™ Venous Stent Study for Treatment of Iliofemoral Occlusive Disease
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: VENOVO™ Venous Stent. Implant of the VENOVO™ Venous Stent |
Device: VENOVO™ Venous Stent
VENOVO™ Venous stent placement
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Primary Patency of the Venous Stent at 12 Months Post-Index Procedure [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) [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.
Secondary Outcome Measures
- Endpoint With Hypothesis Testing: Index of Venous Clinical Severity Score (VCSS) From Baseline to 12 Months [Evaluation at 12 months post-index procedure]
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 [Evaluation at 12 months post-index procedure]
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 [Evaluation through 30 day, 6 months and 12 months post index 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 [At time of Index Procedure]
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) [Less than 30 days post index procedure]
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) [At the conclusion of index procedure]
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) [Evaluation throrugh 30 day, 6 months and 12 months post index procedure]
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) [Evaluation through 30 days, 6 months and 12 months post index procedure]
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 [Evaluation at 12 months post-index procedure]
Stents were evaluated at the 12 month follow-up for fracture analysis. Evaluable ITT subjects are included in this analysis.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Vascular Breakthroughs, LLC | Darien | Connecticut | United States | 06820 |
| 2 | Yale University | New Haven | Connecticut | United States | 06520 |
| 3 | Midwest Cardiovascular Research Foundation | Davenport | Iowa | United States | 52803 |
| 4 | Metro Health Hospital | Wyoming | Michigan | United States | 49519 |
| 5 | Cox Medical Centers | Springfield | Missouri | United States | 65807 |
| 6 | Mount Sinai Medical Center | New York | New York | United States | 10029 |
| 7 | North Carolina Heart and Vascular | Raleigh | North Carolina | United States | 27607 |
| 8 | Cardiothoracic and Vascular Surgeons | Austin | Texas | United States | 78746 |
| 9 | Centra Health, Inc., dba Stroobants Cardiovascular Center | Lynchburg | Virginia | United States | 24501 |
| 10 | Sentara Medical Group | Virginia Beach | Virginia | United States | 23542 |
| 11 | Lake Washington Vascular, PLLC | Bellevue | Washington | United States | 98004 |
| 12 | CAMC Health Education and Research Institute | Charleston | West Virginia | United States | 25304 |
| 13 | Royal Prince Alfred Hospital | Camperdown | New South Wales | Australia | 2050 |
| 14 | JMLS Medical Services PTY LTDT/A PERTH INST. of VASCULAR RESEARCH | Perth | Western Australia | Australia | 6009 |
| 15 | Uniklinik RWTH | Aachen | Germany | 52074 | |
| 16 | Klinikum Arnberg | Arnsberg | Germany | 59755 | |
| 17 | Universitaets-Herrzentrum Freiburg-Bad Krozingen | Bad Krozingen | Germany | 79189 | |
| 18 | University Hospital Galway | Gaillimh | Ireland | H91 YR71 | |
| 19 | MUMC Maastricht | Maastricht | Netherlands | 6202 AZ | |
| 20 | Fundacion de investigacion HM Hospitales | Madrid | Spain | 28660 | |
| 21 | Guy's & St. Thomas' Hospital | London | United Kingdom | SE1 7EH |
Sponsors and Collaborators
- C. R. Bard
Investigators
- Principal Investigator: Michael Dake, MD, Lead Principal Investigator
Study Documents (Full-Text)
More Information
Publications
None provided.- BPV-14-007
Study Results
Participant Flow
| Recruitment Details | The study was activated at 25 investigational sites in the U.S., Europe and Australia. First subject was enrolled June 15, 2016, and the last subject on May 1, 2017. Approximately 60% of subjects are in the U.S. |
|---|---|
| Pre-assignment Detail | Three U.S. sites were activated, but did not consent subjects. A fourth site enrolled 1 subject who was lost to follow-up after discharge (site closed). Fifty-eight (58) screen failures reported and three (3) eligible subjects were not treated with the device. In total, 170 subjects were treated with VENOVO. |
| Arm/Group Title | VENOVO™ Venous Stent. |
|---|---|
| Arm/Group Description | Implant of the VENOVO™ Venous Stent VENOVO™ Venous Stent: VENOVO™ Venous stent placement |
| Period Title: Overall Study | |
| STARTED | 170 |
| COMPLETED | 156 |
| NOT COMPLETED | 14 |
Baseline Characteristics
| Arm/Group Title | VENOVO™ Venous Stent. |
|---|---|
| Arm/Group Description | Implant of the VENOVO™ Venous Stent VENOVO™ Venous Stent: VENOVO™ Venous stent placement |
| Overall Participants | 170 |
| Age, Customized (Count of Participants) | |
| < 65 years |
125
73.5%
|
| ≥ 65 years |
45
26.5%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
107
62.9%
|
| Male |
63
37.1%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
12
7.1%
|
| Not Hispanic or Latino |
158
92.9%
|
| Unknown or Not Reported |
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
4
2.4%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
9
5.3%
|
| White |
156
91.8%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
1
0.6%
|
| Region of Enrollment (Count of Participants) | |
| Netherlands |
8
4.7%
|
| United States |
100
58.8%
|
| Ireland |
4
2.4%
|
| United Kingdom |
8
4.7%
|
| Australia |
5
2.9%
|
| Germany |
34
20%
|
| Spain |
11
6.5%
|
| Cardiovascular Disease (Count of Participants) | |
| Stroke |
4
2.4%
|
| Angina |
5
2.9%
|
| Hypertension |
55
32.4%
|
| Coronary Artery Disease (CAD) |
15
8.8%
|
| Myocardial Infarction (MI) |
6
3.5%
|
| Transient Ischemic Attack (TIA) |
3
1.8%
|
| Cardiomyopathy |
3
1.8%
|
| Vascular Heart Disease |
2
1.2%
|
| Deep Vein Thrombosis (DVT) |
92
54.1%
|
| May-Thurner Syndrome |
102
60%
|
| Venous Valve Disease |
12
7.1%
|
| Varicosis |
133
78.2%
|
| Dyslipidemia |
47
27.6%
|
| Peripheral Arterial Disease (PAD) |
18
10.6%
|
| Atrial Fibrillation (A-FIB) |
6
3.5%
|
| Arrhythmia (other than A-FIB) |
8
4.7%
|
| Renal Disease (Count of Participants) | |
| Chronic Kidney Disease |
4
2.4%
|
| Acute Renal Insufficiency |
1
0.6%
|
| Uremia |
1
0.6%
|
| Disease Category (Count of Participants) | |
| Post-Thrombotic Syndrome (PTS) |
93
54.7%
|
| Non-Thrombotic Iliac Vein Lesions (NIVL) |
77
45.3%
|
| Number of Target Lesions (Count of Participants) | |
| 1 |
154
90.6%
|
| 2 |
16
9.4%
|
| Number of Study Devices Used (Count of Participants) | |
| 1 Study Device |
122
71.8%
|
| 2 Study Devices |
47
27.6%
|
| 3 Study Devices |
1
0.6%
|
| Target Limb (Count of Participants) | |
| Right Leg |
28
16.5%
|
| Left Leg |
142
83.5%
|
Outcome Measures
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT subjects. 25 subjects were excluded from the denominator due to discontinuation or other reasons prior to 12 month follow-up visit. |
| Arm/Group Title | VENOVO™ Venous Stent. |
|---|---|
| Arm/Group Description | Implant of the VENOVO™ Venous Stent VENOVO™ Venous Stent: VENOVO™ Venous stent placement |
| Measure Participants | 145 |
| Count of Participants [Participants] |
128
75.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | VENOVO™ Venous Stent. |
|---|---|---|
| Comments | Hypothesis: H0 :Primary patency rate at 12 months post-index procedure from the overall VENOVO Venous Stent (BVS) patients (PTS and NIVL combined) is at most as good as that of the PG. Ha: Primary patency rate at 12 months post-index procedure from the overall VENOVO Venous Stent (BVS) patients (PTS and NIVL combined) is better than that of PG. | |
| Type of Statistical Test | Non-Inferiority | |
| Comments | PG of 74%, which was set at 10% (non-inferiority margin) below the weighted mean of primary patency (PP2) rate at 12 month at a combination of 55% (PTS) subjects at primary patency rate of 77.1% and 45% (NIVL) subjects at primary patency rate of 93.4%. When taking into consideration both co-primary efficacy and safety endpoints, with 138 BVS subjects, the overall study power is at least 85%*99%=84%. | |
| Statistical Test of Hypothesis | p-Value | 0.0001 |
| Comments | ||
| Method | Weighted Z-statistics | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Weighted Z-statistics |
| Estimated Value | 88.3 | |
| Confidence Interval |
(1-Sided) 90% 82.4 to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT subjects. Results adjudicated by CEC. MAEs that occurred prior to day 30 of each subject's follow-up were counted as failures toward primary safety (n= 11). Those subjects were considered not evaluable and not included in the denominator for the primary safety endpoint (total evaluable = 170 subjects). |
| Arm/Group Title | VENOVO™ Venous Stent. |
|---|---|
| Arm/Group Description | Implant of the VENOVO™ Venous Stent VENOVO™ Venous Stent: VENOVO™ Venous stent placement |
| Measure Participants | 170 |
| Count of Participants [Participants] |
159
93.5%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | VENOVO™ Venous Stent. |
|---|---|---|
| Comments | Hypothesis: H0: The primary safety endpoint absence from event rate in the VENOVO Venous Stent (BVS) through 30 day at most as large as that of the PG. Ha: The primary safety endpoint absence from event rate in the VENOVO Venous Stent (BVS) through 30 day is better than that of the PG. | |
| Type of Statistical Test | Non-Inferiority | |
| Comments | The primary safety endpoint was evaluated against the PG of 89% which was set at 10% (non-inferiority margin) below the literature-derived average freedom from MAE rate at 30 day of 99%. A one-side p-value is derived based on an exact binomial test. When taking into consideration both co-primary efficacy and safety endpoints, with 138 BVS subjects, the overall study power is at least 85%*99%=84%. | |
| Statistical Test of Hypothesis | p-Value | 0.0322 |
| Comments | ||
| Method | Exact binomial test | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Exact binomial test |
| Estimated Value | 93.5 | |
| Confidence Interval |
(1-Sided) 90% 89.5 to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable ITT subjects are included in this analysis.(n) varies in relation to the number of evaluable subjects. Accordingly, the (n) for each period may be different from the overall (N) reported in the Participant Flow section. |
| Arm/Group Title | VENOVO™ Venous Stent. |
|---|---|
| Arm/Group Description | Implant of the VENOVO™ Venous Stent VENOVO™ Venous Stent: VENOVO™ Venous stent placement |
| Measure Participants | 155 |
| Mean (95% Confidence Interval) [Scores on a scale] |
-1.7
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | VENOVO™ Venous Stent. |
|---|---|---|
| Comments | H0: The distribution at the 12-month follow-up remains unimproved compared to baseline. Ha: The distribution shifts toward lower (less pain) classes. | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | this p value is < 0.001. | |
| Method | t-test, 2 sided | |
| Comments | ||
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable ITT subjects were included in this analysis. (n) varies in relation to the number of evaluable subjects. Accordingly, the (n) for each period may be different from the overall (N) reported in the Participant Flow section. |
| Arm/Group Title | VENOVO™ Venous Stent. |
|---|---|
| Arm/Group Description | Implant of the VENOVO™ Venous Stent VENOVO™ Venous Stent: VENOVO™ Venous stent placement |
| Measure Participants | 153 |
| Mean (95% Confidence Interval) [Scores on a scale] |
-15.7
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | VENOVO™ Venous Stent. |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | p value is < 0.001 | |
| Method | t-test, 2 sided | |
| Comments | ||
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable ITT subjects are included in this analysis. (n) varies in relation to the number of evaluable subjects at 30 days, 6 months and 12 months. Accordingly, the (n) for each period may be different from the overall (N) reported in the Participant Flow section. |
| Arm/Group Title | VENOVO™ Venous Stent. |
|---|---|
| Arm/Group Description | Implant of the VENOVO™ Venous Stent VENOVO™ Venous Stent: VENOVO™ Venous stent placement |
| Measure Participants | 170 |
| 30 day post procedure |
-1.1
(1.26)
|
| 6 months post procedure |
-1.3
(1.34)
|
| 12 months post procedure |
-1.5
(1.33)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | VENOVO™ Venous Stent. |
|---|---|
| Arm/Group Description | Implant of the VENOVO™ Venous Stent VENOVO™ Venous Stent: VENOVO™ Venous stent placement |
| Measure Participants | 170 |
| Count of Participants [Participants] |
170
100%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | VENOVO™ Venous Stent. |
|---|---|
| Arm/Group Description | Implant of the VENOVO™ Venous Stent VENOVO™ Venous Stent: VENOVO™ Venous stent placement |
| Measure Participants | 170 |
| Count of Participants [Participants] |
168
98.8%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | VENOVO™ Venous Stent. |
|---|---|
| Arm/Group Description | Implant of the VENOVO™ Venous Stent VENOVO™ Venous Stent: VENOVO™ Venous stent placement |
| Measure Participants | 170 |
| Count of Participants [Participants] |
170
100%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| (n) varies in relation to the number of evaluable subjects at 30 days, 6 months and 12 months. Accordingly, the (n) for each period may be different from the overall (N) reported in the Participant Flow section. |
| Arm/Group Title | VENOVO™ Venous Stent. |
|---|---|
| Arm/Group Description | Implant of the VENOVO™ Venous Stent VENOVO™ Venous Stent: VENOVO™ Venous stent placement |
| Measure Participants | 170 |
| 30 day post procedure |
164
96.5%
|
| 6 months post procedure |
161
94.7%
|
| 12 months post procedure |
151
88.8%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| (n) varies in relation to the number of evaluable subjects at 30 days, 6 months and 12 months. Accordingly, the (n) for each period may be different from the overall (N) reported in the Participant Flow section. |
| Arm/Group Title | VENOVO™ Venous Stent. |
|---|---|
| Arm/Group Description | Implant of the VENOVO™ Venous Stent VENOVO™ Venous Stent: VENOVO™ Venous stent placement |
| Measure Participants | 170 |
| 30 days post procedure |
164
96.5%
|
| 6 months post procedure |
161
94.7%
|
| 12 months post procedure |
151
88.8%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable ITT subjects are included in this analysis. (n) varies in relation to the number of evaluable subjects. Accordingly, the (n) for each period may be different from the overall (N) reported in the Participant Flow section. |
| Arm/Group Title | VENOVO™ Venous Stent. |
|---|---|
| Arm/Group Description | Implant of the VENOVO™ Venous Stent VENOVO™ Venous Stent: VENOVO™ Venous stent placement |
| Measure Participants | 137 |
| No Device Stent Fracture at 12 months |
137
80.6%
|
| Device Stent Fracture at 12 months |
0
0%
|
Adverse Events
| Time Frame | Adverse Events (AEs) and Serious Adverse Events (SAEs) are presented during the 12-month follow-up period. All AEs were reviewed by the CEC and a total of 129 events were adjudicated as per the committee charter. Results for ITT subjects are reported for both SAEs and AEs. AEs that occurred through 395 days for each subject are included. | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | VENOVO™ Venous Stent. | |
| Arm/Group Description | Implant of the VENOVO™ Venous Stent VENOVO™ Venous Stent: VENOVO™ Venous stent placement | |
All Cause Mortality |
||
| VENOVO™ Venous Stent. | ||
| Affected / at Risk (%) | # Events | |
| Total | 4/170 (2.4%) | |
Serious Adverse Events |
||
| VENOVO™ Venous Stent. | ||
| Affected / at Risk (%) | # Events | |
| Total | 44/170 (25.9%) | |
| Blood and lymphatic system disorders | ||
| Haemorrhagic Anaemia | 3/170 (1.8%) | 3 |
| Cardiac disorders | ||
| Acute myocardial infarction | 1/170 (0.6%) | 1 |
| Angina pectoris | 1/170 (0.6%) | 1 |
| Angina unstable | 1/170 (0.6%) | 1 |
| Cardiac failure congestive | 2/170 (1.2%) | 2 |
| Coronary artery disease | 1/170 (0.6%) | 1 |
| Eye disorders | ||
| Retinal detachment | 1/170 (0.6%) | 1 |
| Gastrointestinal disorders | ||
| Coeliac artery stenosis | 1/170 (0.6%) | 1 |
| Diverticular perforation | 1/170 (0.6%) | 1 |
| Haemorrhoidal haemorrhage | 1/170 (0.6%) | 1 |
| Rectal haemorrhage | 1/170 (0.6%) | 1 |
| Umbilical hernia | 1/170 (0.6%) | 1 |
| General disorders | ||
| Chest discomfort | 1/170 (0.6%) | 1 |
| Death | 2/170 (1.2%) | 2 |
| Device occlusion | 3/170 (1.8%) | 3 |
| Local swelling | 1/170 (0.6%) | 1 |
| Oedema peripheral | 1/170 (0.6%) | 1 |
| Thrombosis in device | 6/170 (3.5%) | 6 |
| Vessel puncture site haematoma | 1/170 (0.6%) | 1 |
| Vessel puncture site pain | 1/170 (0.6%) | 1 |
| Immune system disorders | ||
| Hypersensitivity | 0/170 (0%) | 0 |
| Infections and infestations | ||
| Arthritis bacterial | 1/170 (0.6%) | 1 |
| Cellulitis | 1/170 (0.6%) | 1 |
| Clostridium difficile infection | 1/170 (0.6%) | 1 |
| Erysipelas | 1/170 (0.6%) | 1 |
| Pneumonia | 1/170 (0.6%) | 1 |
| Urinary tract infection | 1/170 (0.6%) | 1 |
| Injury, poisoning and procedural complications | ||
| Femoral neck fracture | 1/170 (0.6%) | 1 |
| Laceration | 0/170 (0%) | 0 |
| Procedural pain | 1/170 (0.6%) | 1 |
| Vascular pseudoaneurysm | 2/170 (1.2%) | 2 |
| Musculoskeletal and connective tissue disorders | ||
| Osteoarthritis | 1/170 (0.6%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Colon cancer | 1/170 (0.6%) | 1 |
| Rectal cancer metastatic | 1/170 (0.6%) | 1 |
| Uterine leiomyoma | 1/170 (0.6%) | 1 |
| Nervous system disorders | ||
| Status epilepticus | 1/170 (0.6%) | 1 |
| Psychiatric disorders | ||
| Alcohol withdrawal syndrome | 1/170 (0.6%) | 1 |
| Panic attacks | 0/170 (0%) | 0 |
| Psychotic disorder | 1/170 (0.6%) | 1 |
| Renal and urinary disorders | ||
| Heamaturia | 1/170 (0.6%) | 1 |
| Renal artery arteriosclerosis | 1/170 (0.6%) | 1 |
| Renal impairment | 2/170 (1.2%) | 2 |
| Reproductive system and breast disorders | ||
| Cystocele | 1/170 (0.6%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| Acute respiratory failure | 1/170 (0.6%) | 1 |
| Epistaxis | 1/170 (0.6%) | 1 |
| Pneumonia aspiration | 1/170 (0.6%) | 1 |
| Skin and subcutaneous tissue disorders | ||
| Diabetic neuropathis ulcer | 1/170 (0.6%) | 1 |
| Rash maculo-papular | 1/170 (0.6%) | 1 |
| Vascular disorders | ||
| Circulatory collapse | 1/170 (0.6%) | 1 |
| Deep vein thrombosis | 2/170 (1.2%) | 2 |
| Iliac vein occlusion | 2/170 (1.2%) | 2 |
| Pelvic vein occlusion | 1/170 (0.6%) | 1 |
| Peripheral arterial occlusive disease | 1/170 (0.6%) | 1 |
| Peripheral artery thrombosis | 1/170 (0.6%) | 1 |
| Post-thrombotic syndrome | 0/170 (0%) | 0 |
| Venous insufficiency | 1/170 (0.6%) | 1 |
| Venous stenosis | 1/170 (0.6%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| VENOVO™ Venous Stent. | ||
| Affected / at Risk (%) | # Events | |
| Total | 63/170 (37.1%) | |
| Blood and lymphatic system disorders | ||
| Anaemia | 1/170 (0.6%) | 1 |
| Leukopenia | 1/170 (0.6%) | 1 |
| Cardiac disorders | ||
| Acute myocardial infarction | 1/170 (0.6%) | 1 |
| Angina pectoris | 2/170 (1.2%) | 2 |
| Coronary artery disease | 1/170 (0.6%) | 1 |
| Myocardial infraction | 1/170 (0.6%) | 1 |
| Palpitation | 1/170 (0.6%) | 1 |
| Eye disorders | ||
| Endocrine ophthalmopathy | 1/170 (0.6%) | 1 |
| Gastrointestinal disorders | ||
| Abdominal pain | 1/170 (0.6%) | 1 |
| Abdominal pain lower | 2/170 (1.2%) | 2 |
| Abdominal tenderness | 1/170 (0.6%) | 1 |
| Constipation | 1/170 (0.6%) | 1 |
| Diverticulum | 2/170 (1.2%) | 2 |
| Gingival bleeding | 1/170 (0.6%) | 1 |
| Mouth haemorrhage | 1/170 (0.6%) | 1 |
| Nausea | 1/170 (0.6%) | 1 |
| Rectal polyp | 1/170 (0.6%) | 1 |
| Toothache | 1/170 (0.6%) | 1 |
| Vomiting | 2/170 (1.2%) | 2 |
| General disorders | ||
| Adverse drug reaction | 4/170 (2.4%) | 4 |
| Fatigue | 2/170 (1.2%) | 2 |
| Hernia | 1/170 (0.6%) | 1 |
| Induration | 1/170 (0.6%) | 1 |
| Injection site discoloration | 2/170 (1.2%) | 2 |
| Injection site discomfort | 3/170 (1.8%) | 3 |
| Injection site haematoma | 1/170 (0.6%) | 1 |
| Injection site induration | 2/170 (1.2%) | 2 |
| Injury associated with device | 1/170 (0.6%) | 1 |
| Local swelling | 1/170 (0.6%) | 1 |
| Non-cardiac chest pain | 1/170 (0.6%) | 1 |
| Oedema peripheral | 3/170 (1.8%) | 3 |
| Thrombosis in device | 4/170 (2.4%) | 4 |
| Vessel puncture site haematoma | 2/170 (1.2%) | 2 |
| Vessel puncture site haemorrhage | 2/170 (1.2%) | 2 |
| Vessel puncture site pain | 4/170 (2.4%) | 4 |
| Vessel puncture site swelling | 1/170 (0.6%) | 1 |
| Immune system disorders | ||
| Hypersensitivity | 2/170 (1.2%) | 2 |
| Infections and infestations | ||
| Bronchitis | 1/170 (0.6%) | 1 |
| Clostridium difficile colitis | 1/170 (0.6%) | 1 |
| Lower respiratory tract infection | 1/170 (0.6%) | 1 |
| Nasopharyngitis | 1/170 (0.6%) | 1 |
| Oesophageal candidiasis | 1/170 (0.6%) | 1 |
| Parotitis | 1/170 (0.6%) | 1 |
| Urinary tract infection | 4/170 (2.4%) | 4 |
| Vaginal infection | 1/170 (0.6%) | 1 |
| Viral infection | 1/170 (0.6%) | 1 |
| Injury, poisoning and procedural complications | ||
| Contusion | 1/170 (0.6%) | 1 |
| Cystitis radiation | 1/170 (0.6%) | 1 |
| Excoriation | 1/170 (0.6%) | 1 |
| Laceration | 3/170 (1.8%) | 3 |
| Limb injury | 1/170 (0.6%) | 1 |
| Meniscus injury | 2/170 (1.2%) | 2 |
| Muscle strain | 3/170 (1.8%) | 3 |
| Nerve injury | 1/170 (0.6%) | 1 |
| Post procedural discomfort | 5/170 (2.9%) | 5 |
| Procedural pain | 11/170 (6.5%) | 11 |
| Upper limb fracture | 1/170 (0.6%) | 1 |
| Investigations | ||
| International normalised ratio increased | 1/170 (0.6%) | 1 |
| Metabolism and nutrition disorders | ||
| Hypokalaemia | 1/170 (0.6%) | 1 |
| Musculoskeletal and connective tissue disorders | ||
| Arthralgia | 8/170 (4.7%) | 8 |
| Back pain | 7/170 (4.1%) | 7 |
| Bursitis | 1/170 (0.6%) | 1 |
| Limb discomfort | 3/170 (1.8%) | 3 |
| Musculoskeletal chest pain | 1/170 (0.6%) | 1 |
| Musculoskeletal discomfort | 2/170 (1.2%) | 2 |
| Osteoarthritis | 2/170 (1.2%) | 2 |
| Pain in extremity | 6/170 (3.5%) | 6 |
| Rhabdomyolysis | 2/170 (1.2%) | 2 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Benign neoplasm of bladder | 1/170 (0.6%) | 1 |
| Prostate cancer recurrent | 2/170 (1.2%) | 2 |
| Uterine leiomyoma | 1/170 (0.6%) | 1 |
| Nervous system disorders | ||
| Burning sensation | 1/170 (0.6%) | 1 |
| Headache | 4/170 (2.4%) | 4 |
| Hypoaesthesia | 4/170 (2.4%) | 4 |
| Meralgia paraesthetica | 1/170 (0.6%) | 1 |
| Paraesthesia | 4/170 (2.4%) | 4 |
| Sciatica | 1/170 (0.6%) | 1 |
| Syncope | 1/170 (0.6%) | 1 |
| Psychiatric disorders | ||
| Mental status change | 1/170 (0.6%) | 1 |
| Panic attack | 1/170 (0.6%) | 1 |
| Renal and urinary disorders | ||
| Haematuria | 1/170 (0.6%) | 1 |
| Nephrolithiasis | 2/170 (1.2%) | 2 |
| Renal failure acute | 2/170 (1.2%) | 2 |
| Urinary incontinence | 1/170 (0.6%) | 1 |
| Urinary retention | 1/170 (0.6%) | 1 |
| Reproductive system and breast disorders | ||
| Menorrhagia | 1/170 (0.6%) | 1 |
| Pelvic pain | 1/170 (0.6%) | 1 |
| Vaginal haemorrhage | 1/170 (0.6%) | 1 |
| Varicose veins pelvic | 1/170 (0.6%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| Acute respiratory failure | 1/170 (0.6%) | 1 |
| Chronic obstructive pulmonary disease | 1/170 (0.6%) | 1 |
| Dyspnoea | 2/170 (1.2%) | 2 |
| Epistaxis | 1/170 (0.6%) | 1 |
| Haemoptysis | 1/170 (0.6%) | 1 |
| Pulmonary embolism | 1/170 (0.6%) | 1 |
| Upper-airway cough syndrome | 1/170 (0.6%) | 1 |
| Skin and subcutaneous tissue disorders | ||
| Blister | 1/170 (0.6%) | 1 |
| Decubitus ulcer | 1/170 (0.6%) | 1 |
| Dermal cyst | 1/170 (0.6%) | 1 |
| Rash | 1/170 (0.6%) | 1 |
| Rash generalized | 1/170 (0.6%) | 1 |
| Rash macular | 1/170 (0.6%) | 1 |
| Skin disorder | 1/170 (0.6%) | 1 |
| Skin ulcer | 3/170 (1.8%) | 3 |
| Vascular disorders | ||
| Deep vein thrombosis | 3/170 (1.8%) | 3 |
| Haematoma | 2/170 (1.2%) | 2 |
| Orthostatic hypotension | 1/170 (0.6%) | 1 |
| Peripheral arterial occlusive disease | 1/170 (0.6%) | 1 |
| Peripheral artery stenosis | 1/170 (0.6%) | 1 |
| Post thrombotic syndrome | 1/170 (0.6%) | 1 |
| Thrombophlebitis superficial | 1/170 (0.6%) | 1 |
| Varicose vein | 7/170 (4.1%) | 7 |
| Vasospasm | 1/170 (0.6%) | 1 |
| Venous insufficiency | 6/170 (3.5%) | 6 |
| Venous stenosis | 1/170 (0.6%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Prior to PI publication of site results, sponsor requires publication of multi-centers results.
Results Point of Contact
| Name/Title | Megan Hill |
|---|---|
| Organization | Becton Dickinson (BPV) |
| Phone | 480-350-6468 |
| Megan.Hill@bd.com |
- BPV-14-007