VIRTUS: An Evaluation of the Vici™ Venous Stent System in Patients With Chronic Iliofemoral Venous Outflow Obstruction
Sponsor
Boston Scientific Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT02112877
Collaborator
(none)
200
24
2
77.8
8.3
0.1
Study Details
Study Description
Brief Summary
This is a prospective, multi-center, single arm, non-randomized study to define safety and efficacy of the Veniti Vici™ Venous Stent System in relation to pre-defined Objective Performance goals. A maximum of 200 patients at up to 45 centers worldwide will be enrolled. Thirty (30) feasibility patients will be enrolled at approximately 7-10 centers and 170 pivotal patients will be enrolled at approximately 45 centers worldwide. The follow-up period is 36 months.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The objective of this prospective study is to assess the safety and efficacy of the Veniti Vici™ Venous Stent System in achieving patency of the target venous lesion in patients who present with clinically significant chronic non-malignant obstruction of the iliofemoral venous outflow tract.
Study Design
Study Type:
Interventional
Actual Enrollment
:
200 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
Thirty (30) patients will be enrolled at approximately 7 centers (feasibility cohort). These patients will not be included in the pivotal study population, but will be evaluated separately for the primary safety and efficacy endpoints as well as for all secondary endpoints. When these 30 feasibility patients have completed their 30-day follow-up, a Data Safety Monitoring Board (DSMB) will review the safety data and will determine if the study can proceed with enrollment of the 170 pivotal subjects.Thirty (30) patients will be enrolled at approximately 7 centers (feasibility cohort). These patients will not be included in the pivotal study population, but will be evaluated separately for the primary safety and efficacy endpoints as well as for all secondary endpoints. When these 30 feasibility patients have completed their 30-day follow-up, a Data Safety Monitoring Board (DSMB) will review the safety data and will determine if the study can proceed with enrollment of the 170 pivotal subjects.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
VIRTUS Safety and Efficacy of the Veniti Vici™ Venous Stent System (Veniti, Inc.) When Used to Treat Clinically Significant Chronic Non-malignant Obstruction of the Iliofemoral Venous Segment
Actual Study Start Date
:
Jun 26, 2014
Actual Primary Completion Date
:
Dec 5, 2017
Actual Study Completion Date
:
Dec 18, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: VICI Stent Implantation - Feasibility Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System |
Device: Veniti Vici™ Venous Stent System
|
| Experimental: VICI Stent Implantation - Pivotal Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System |
Device: Veniti Vici™ Venous Stent System
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Major Adverse Events (MAE) [30 days]
The primary safety endpoint for this study will be a composite endpoint of any major adverse event (MAE) within 30 days, as adjudicated by a Clinical Events Committee.
- Percentage of Participants That Demonstrated Primary Patency [12 months post-intervention]
The primary effectiveness endpoint is the primary patency rate at 12 months post-intervention, defined as freedom from occlusion by thrombosis, freedom from surgical or endovascular intervention on target vessel which are found to have re-stenosis or stent occlusion to maintain patency, and freedom from in-stent stenosis more than 50% by venogram.
Secondary Outcome Measures
- Number of Participants With Improvement in Venous Clinical Severity Score (VCSS) [12 months post-intervention]
The secondary effectiveness endpoint for this study will be a binary response variable based on an improvement in Venous Clinical Severity Score (VCSS) by at least 50% at 12 months post-intervention. VCSS measures 10 clinical attributes of venous disease (Pain, Varicose Veins, Venous Edema, Skin Pigmentation, Inflammation, Induration, No. Active Ulcers, Active Ulcer Size, Ulcer Duration and Compression Therapy) on a scale of 0 - 3 (Absent 0, Mild 1, Moderate 2, and Severe 3).
Other Outcome Measures
- Number of Participants With Procedural Technical Success [During Procedure]
Procedural technical success is achievement of a final residual target vessel diameter stenosis of ≤50% as measured on the post procedural venogram, without skipped lesion regions, with placement of the study device alone with or without post-stenting balloon dilation as needed.
- Number of Participants With Lesion Success [During Procedure]
Lesion success is defined as achievement of ≤50% residual diameter stenosis of the target lesion using any percutaneous method (including the use of non-study devices).
- Number of Participants With Procedural Success [From the time of the Index Procedure post procedural venogram through the time of Index Procedure Discharge or 3 days Post-Procedure (whichever comes first)]
Procedural success is defined as procedural technical success without the occurrence of a major adverse event (MAE) between the index procedure and discharge.
- Number of Participants With Late Technical Success [12 months post-intervention]
Late technical success (through 12 months) is the absence of device movement >10mm related to anatomical landmarks or any migration leading to symptoms or requiring therapy; absence of stent occlusion by thrombosis or restenosis, defined as reduction in treated segment lumen more than 50% from the post-procedure vessel lumen diameter as measured by post-procedural venogram or DUS and maintenance of structural integrity, defined as the absence of pinching (focal compression), kinking (stent doubling or bending upon itself) that results in >50% diameter reduction of the stent, recoil (poor radial resistive force) or absence of fractures .
- Change in the Quality of Life (Chronic Venous Insufficiency Questionnaire)(CIVIQ2)) [Baseline and 12 months post-intervention]
The overall change in CIVIQ2 scores for the study patients, calculated using the mean scores at baseline and 12-months. This instrument is scored from 20 to 100 points with lower scores indicating a lesser impact on health.
- Number of Participants With Estimated Primary-Assisted Patency [12 months post-intervention]
Primary-assisted patency is defined as freedom from occlusion regardless of whether an intervention (subsequent to the index procedure) was performed.
- Number of Participants With Estimated Secondary Patency [36 months post-intervention]
Secondary patency is defined as freedom from "permanent" loss of patency determined through last follow-up (irrespective of the number of interventions).
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria - Pre-Procedure Criteria:
-
Age ≥ 18 years
-
Willing and capable of complying with all follow-up evaluations at the specified times
-
Able and willing to provide written informed consent prior to study-specific procedures
-
Presence of unilateral, clinically significant, chronic non-malignant obstruction of the common femoral vein, external iliac vein, common iliac vein, or any combination thereof, defined as a ≥50% reduction in target vessel lumen diameter (to be measured by venogram during procedure)
-
Clinically significant venous obstruction defined as meeting at least one of the following clinical indicators:
-
Clinical severity class of CEAP classification ≥3
-
VCSS Pain Score ≥2
-
Negative pregnancy test in females of child-bearing potential
-
Intention to stent the target lesion only with the Veniti Vici Venous Stent
Exclusion Criteria - Pre-Procedure Criteria:
-
Presence or history of clinically significant pulmonary emboli within 6 months prior to enrollment.
-
Venous obstruction that extends into the inferior vena cava (IVC)
-
Contralateral disease of the common femoral vein, external iliac vein, common iliac vein, or any combination thereof with planned treatment within 30 days after subject enrollment
-
Life expectancy <12 months
-
Female of childbearing potential who is pregnant or plans to become pregnant during the duration of the clinical study
-
Uncontrolled or active coagulopathy OR known, uncorrectable bleeding diathesis with the following definitions:
-
Uncorrected INR ≥2.0 or aPTT ≥1.5 X normal local lab value
-
Platelet count <80,000
-
Uncorrected hemoglobin of ≤ 9 g/dL
-
Patients with an estimated glomerular filtration rate (eGFR) <30 mL/min. In patients with diabetes mellitus, eGFR <45 mL/min.
-
Known hypersensitivity to nickel or titanium
-
Contrast agent allergy that cannot be managed adequately with pre-medication
-
Intended concurrent thrombolysis or thrombectomy procedure OR intended or planned (within 30 days) adjuvant procedure such as creation of temporary arteriovenous fistula, placement of IVC filter, endovenectomy or saphenous vein ablation
-
Current or recent (within 30 days) active participation in another drug or device clinical trial (Participation in observational studies is acceptable.)
-
Patient judged to be a poor candidate by the primary investigator
-
Patients who have had any prior surgical or endovascular intervention of the target vessel [Note: Patients who have had catheter-directed or mechanical thrombolysis in the target vessel for DVT at least 3 month (90 days) prior to the VIRTUS index procedure may be included in the trial.]
Exclusion Criteria - Intra-Procedural Criteria:
-
Patients in whom the lesions cannot be traversed with a guide wire.
-
Patients where the obstruction extends into the inferior vena cava or below the level of the lesser trochanter.
-
Patients whose vein diameters are not within limits stated in current Instructions for Use as determined by venogram.
-
Patients who do not meet the venogram binary stenosis definition, as determined by the treating physician.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Abrazo Arizona Heart Hospital | Phoenix | Arizona | United States | 85016 |
| 2 | Healthfinity PLCC | Scottsdale | Arizona | United States | 85254 |
| 3 | Arkansas Site Management Services, LLC | Little Rock | Arkansas | United States | 72211 |
| 4 | St. Joseph Hospital | Orange | California | United States | 92868 |
| 5 | Radiology Imaging Associates | Englewood | Colorado | United States | 80112 |
| 6 | Vascular Breakthroughs | Darien | Connecticut | United States | 06820 |
| 7 | Midwest Cardiovascular Foundation | Davenport | Iowa | United States | 52803 |
| 8 | Imperial Health, LLP | Lake Charles | Louisiana | United States | 70601 |
| 9 | Michigan Vascular Center | Flint | Michigan | United States | 48507 |
| 10 | NYU School of Medicine | New York | New York | United States | 10016 |
| 11 | Icahn School of Medicine at Mount Sinai | New York | New York | United States | 10029 |
| 12 | New York Presbyterian Hospital/Cornell University | New York | New York | United States | 10065 |
| 13 | The University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | United States | 27599 |
| 14 | Dr. Ediberto Soto-Cora | El Paso | Texas | United States | 79925 |
| 15 | Sentara Vascular Specialists | Norfolk | Virginia | United States | 23507 |
| 16 | University of Washington Medical Center | Seattle | Washington | United States | 98195 |
| 17 | Infermerierie Protestante de Lyon | Decines Charpieu | France | ||
| 18 | Hôpital Nord de Marseille | Marsaille | France | ||
| 19 | Klinikum Arnsberg, Karolinen Hospital | Arnsberg | Germany | ||
| 20 | University Hospital Galway | Galway | Ireland | ||
| 21 | Rijnstate Ziekenhuis | Arnhem | Netherlands | ||
| 22 | University Hospital HM Monteprincipe | Madrid | Spain | ||
| 23 | Guy's and St Thomas' NHS Foundation Trust | London | United Kingdom | ||
| 24 | University College London | London | United Kingdom |
Sponsors and Collaborators
- Boston Scientific Corporation
Investigators
- Principal Investigator: William Marston, MD, UNC Department of Surgery
- Principal Investigator: Mahmood Razavi, MD, Vascular and Interventional Specialists of Orange County
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT02112877
Other Study ID Numbers:
- STE-HUM-004P
- STE-HUM-007P
First Posted:
Apr 14, 2014
Last Update Posted:
Apr 15, 2021
Last Verified:
Mar 1, 2021
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Boston Scientific Corporation
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | A total of 200 subjects have been enrolled in the VIRTUS Trial, including 30 subjects in the feasibility cohort and 170 subjects in the pivotal cohort. |
| Arm/Group Title | VICI Stent Implantation - Feasibility | VICI Stent Implantation - Pivotal |
|---|---|---|
| Arm/Group Description | Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System | Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System |
| Period Title: Overall Study | ||
| STARTED | 30 | 170 |
| COMPLETED | 28 | 157 |
| NOT COMPLETED | 2 | 13 |
Baseline Characteristics
| Arm/Group Title | VICI Stent Implantation - Feasibility | VICI Stent Implantation - Pivotal | Total |
|---|---|---|---|
| Arm/Group Description | Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System | Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System | Total of all reporting groups |
| Overall Participants | 30 | 170 | 200 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
44.4
(14.3)
|
54.4
(16.2)
|
52.9
(16.3)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
24
80%
|
96
56.5%
|
120
60%
|
| Male |
6
20%
|
74
43.5%
|
80
40%
|
| Race/Ethnicity, Customized (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
1
0.6%
|
1
0.5%
|
| Asian |
2
6.7%
|
5
2.9%
|
7
3.5%
|
| Black or African American |
1
3.3%
|
20
11.8%
|
21
10.5%
|
| Native Hawaiian or Pacific Islander |
0
0%
|
1
0.6%
|
1
0.5%
|
| White |
25
83.3%
|
127
74.7%
|
152
76%
|
| White African |
0
0%
|
1
0.6%
|
1
0.5%
|
| Latin American |
0
0%
|
1
0.6%
|
1
0.5%
|
| Not Answered |
0
0%
|
14
8.2%
|
14
7%
|
| North African |
2
6.7%
|
0
0%
|
2
1%
|
| Race/Ethnicity, Customized (Count of Participants) | |||
| Hispanic or Latino |
2
6.7%
|
13
7.6%
|
15
7.5%
|
| Not Hispanic or Latino |
25
83.3%
|
141
82.9%
|
166
83%
|
| Region of Enrollment (Count of Participants) | |||
| Netherlands |
1
3.3%
|
0
0%
|
1
0.5%
|
| United States |
8
26.7%
|
119
70%
|
127
63.5%
|
| Ireland |
3
10%
|
5
2.9%
|
8
4%
|
| United Kingdom |
10
33.3%
|
22
12.9%
|
32
16%
|
| France |
3
10%
|
18
10.6%
|
21
10.5%
|
| Germany |
0
0%
|
5
2.9%
|
5
2.5%
|
| Spain |
5
16.7%
|
1
0.6%
|
6
3%
|
| Chronic Non-Malignant Obstruction (Count of Participants) | |||
| Left Leg |
24
80%
|
145
85.3%
|
169
84.5%
|
| Right Leg |
5
16.7%
|
24
14.1%
|
29
14.5%
|
| Both Legs |
1
3.3%
|
1
0.6%
|
2
1%
|
| Clinical Etiology Anatomy Pathophysiology (CEAP) Assessment (Count of Participants) | |||
| 0 (No visible or palpable signs of venous disease |
1
3.3%
|
2
1.2%
|
3
1.5%
|
| 1 (Telangiectasia or reticular veins) |
0
0%
|
0
0%
|
0
0%
|
| 2 (Varicose Veins) |
0
0%
|
2
1.2%
|
2
1%
|
| 3 (Edema) |
13
43.3%
|
45
26.5%
|
58
29%
|
| 4 (Skin changes ascribed to venous disease) |
13
43.3%
|
78
45.9%
|
91
45.5%
|
| 5 (Healed ulceration) |
2
6.7%
|
22
12.9%
|
24
12%
|
| 6 (Active ulceration) |
1
3.3%
|
21
12.4%
|
22
11%
|
| Venous Clinical Severity Score (VCSS) Leg Pain (Target Limb) (Count of Participants) | |||
| Absent |
2
6.7%
|
15
8.8%
|
17
8.5%
|
| Mild |
2
6.7%
|
35
20.6%
|
37
18.5%
|
| Moderate |
17
56.7%
|
54
31.8%
|
71
35.5%
|
| Severe |
9
30%
|
42
24.7%
|
51
25.5%
|
| Diabetic (Count of Participants) | |||
| Count of Participants [Participants] |
2
6.7%
|
29
17.1%
|
31
15.5%
|
| Smoking History (Count of Participants) | |||
| Current Smoker |
3
10%
|
21
12.4%
|
24
12%
|
| Former Smoker |
8
26.7%
|
41
24.1%
|
49
24.5%
|
| Non-Smoker |
19
63.3%
|
108
63.5%
|
127
63.5%
|
| History of Pulmonary Embolism (PE) (Count of Participants) | |||
| Count of Participants [Participants] |
2
6.7%
|
28
16.5%
|
30
15%
|
| History of Deep Vein Thrombosis (DVT) (Count of Participants) | |||
| Count of Participants [Participants] |
19
63.3%
|
119
70%
|
138
69%
|
| History of Coronary Artery Disease (CAD) (Count of Participants) | |||
| Count of Participants [Participants] |
0
0%
|
14
8.2%
|
14
7%
|
| History of Myocardial Infarction (MI) within past 5 years (Count of Participants) | |||
| Count of Participants [Participants] |
0
0%
|
1
0.6%
|
1
0.5%
|
| History of Coronary Artery Bypass Grafting (CABG) (Count of Participants) | |||
| Count of Participants [Participants] |
0
0%
|
4
2.4%
|
4
2%
|
| History of Percutaneous Transluminal Coronary Angioplasty (PTCA)/Stent (Count of Participants) | |||
| Count of Participants [Participants] |
0
0%
|
4
2.4%
|
4
2%
|
| History of Congestive Heart Failure (CHF) (Count of Participants) | |||
| Count of Participants [Participants] |
0
0%
|
4
2.4%
|
4
2%
|
| History of Hypertension (HTN) (Count of Participants) | |||
| Count of Participants [Participants] |
7
23.3%
|
68
40%
|
75
37.5%
|
| History of Hepatic Disease (Count of Participants) | |||
| Count of Participants [Participants] |
1
3.3%
|
5
2.9%
|
6
3%
|
| History of Renal Disease (Count of Participants) | |||
| Count of Participants [Participants] |
1
3.3%
|
8
4.7%
|
9
4.5%
|
| History of Peripheral Vascular Disease (PVD) (Count of Participants) | |||
| Count of Participants [Participants] |
2
6.7%
|
29
17.1%
|
31
15.5%
|
| History of Coagulation Disorder (Count of Participants) | |||
| Count of Participants [Participants] |
7
23.3%
|
23
13.5%
|
30
15%
|
| History of Cerebrovascular Accident (CVA) (Count of Participants) | |||
| Count of Participants [Participants] |
1
3.3%
|
10
5.9%
|
11
5.5%
|
| History of Cancer (Count of Participants) | |||
| Count of Participants [Participants] |
2
6.7%
|
18
10.6%
|
20
10%
|
| History of Recent Trauma (Count of Participants) | |||
| Count of Participants [Participants] |
1
3.3%
|
3
1.8%
|
4
2%
|
| History of Allergies (Count of Participants) | |||
| Count of Participants [Participants] |
4
13.3%
|
60
35.3%
|
64
32%
|
Outcome Measures
| Title | Number of Participants With Major Adverse Events (MAE) |
|---|---|
| Description | The primary safety endpoint for this study will be a composite endpoint of any major adverse event (MAE) within 30 days, as adjudicated by a Clinical Events Committee. |
| Time Frame | 30 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| For the pivotal cohort, one subject never returned for follow-up after discharge. |
| Arm/Group Title | VICI Stent Implantation - Feasibility | VICI Stent Implantation - Pivotal |
|---|---|---|
| Arm/Group Description | Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System | Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System |
| Measure Participants | 30 | 169 |
| Device or procedure-related death |
0
0%
|
0
0%
|
| Device or procedure-related bleeding |
0
0%
|
0
0%
|
| Device or procedure-related arterial/venous injury |
2
6.7%
|
2
1.2%
|
| Device or procedure-related acuteDeepVeinThrombus |
0
0%
|
0
0%
|
| Clinically significant pulmonary embolism |
0
0%
|
0
0%
|
| Embolization of the stent |
0
0%
|
0
0%
|
| Title | Percentage of Participants That Demonstrated Primary Patency |
|---|---|
| Description | The primary effectiveness endpoint is the primary patency rate at 12 months post-intervention, defined as freedom from occlusion by thrombosis, freedom from surgical or endovascular intervention on target vessel which are found to have re-stenosis or stent occlusion to maintain patency, and freedom from in-stent stenosis more than 50% by venogram. |
| Time Frame | 12 months post-intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| For the feasibility cohort, month 12 outcomes were available for 22 subjects. For the pivotal cohort, month 12 outcomes were available for 125 subjects. Those without venography performed at 12 months had their result assigned by random selection from subjects with a venogram result who had the same anatomy and the same DUS outcome (if available). |
| Arm/Group Title | VICI Stent Implantation - Feasibility | VICI Stent Implantation - Pivotal |
|---|---|---|
| Arm/Group Description | Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System | Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System |
| Measure Participants | 22 | 170 |
| Number [Percentage of Participants] |
77.3
257.7%
|
84.0
49.4%
|
| Title | Number of Participants With Improvement in Venous Clinical Severity Score (VCSS) |
|---|---|
| Description | The secondary effectiveness endpoint for this study will be a binary response variable based on an improvement in Venous Clinical Severity Score (VCSS) by at least 50% at 12 months post-intervention. VCSS measures 10 clinical attributes of venous disease (Pain, Varicose Veins, Venous Edema, Skin Pigmentation, Inflammation, Induration, No. Active Ulcers, Active Ulcer Size, Ulcer Duration and Compression Therapy) on a scale of 0 - 3 (Absent 0, Mild 1, Moderate 2, and Severe 3). |
| Time Frame | 12 months post-intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| For the feasibility cohort, 7 subjects did not have VCSS results at both month 12 and baseline. For the pivotal cohort, results for 24 subjects from a single US center are not included due to data integrity issues and 14 subjects did not have VCSS results at both month 12 and Baseline. |
| Arm/Group Title | VICI Stent Implantation - Feasibility | VICI Stent Implantation - Pivotal |
|---|---|---|
| Arm/Group Description | Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System | Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System |
| Measure Participants | 23 | 132 |
| Count of Participants [Participants] |
13
43.3%
|
65
38.2%
|
| Title | Number of Participants With Procedural Technical Success |
|---|---|
| Description | Procedural technical success is achievement of a final residual target vessel diameter stenosis of ≤50% as measured on the post procedural venogram, without skipped lesion regions, with placement of the study device alone with or without post-stenting balloon dilation as needed. |
| Time Frame | During Procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| For the pivotal cohort, four subjects did not have the post-procedural venogram available for assessment. Additionally, there were two subjects that failed the endpoint due to two investigators using non-study stents. |
| Arm/Group Title | VICI Stent Implantation - Feasibility | VICI Stent Implantation - Pivotal |
|---|---|---|
| Arm/Group Description | Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System | Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System |
| Measure Participants | 30 | 166 |
| Count of Participants [Participants] |
30
100%
|
164
96.5%
|
| Title | Number of Participants With Lesion Success |
|---|---|
| Description | Lesion success is defined as achievement of ≤50% residual diameter stenosis of the target lesion using any percutaneous method (including the use of non-study devices). |
| Time Frame | During Procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| For the pivotal cohort, four subjects did not have the post-procedural veogram available for assessment. |
| Arm/Group Title | VICI Stent Implantation - Feasibility | VICI Stent Implantation - Pivotal |
|---|---|---|
| Arm/Group Description | Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System | Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System |
| Measure Participants | 30 | 166 |
| Count of Participants [Participants] |
30
100%
|
166
97.6%
|
| Title | Number of Participants With Procedural Success |
|---|---|
| Description | Procedural success is defined as procedural technical success without the occurrence of a major adverse event (MAE) between the index procedure and discharge. |
| Time Frame | From the time of the Index Procedure post procedural venogram through the time of Index Procedure Discharge or 3 days Post-Procedure (whichever comes first) |
Outcome Measure Data
| Analysis Population Description |
|---|
| For the pivotal cohort, four subjects did not have the post-procedural venogram available for assessment. |
| Arm/Group Title | VICI Stent Implantation - Feasibility | VICI Stent Implantation - Pivotal |
|---|---|---|
| Arm/Group Description | Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System | Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System |
| Measure Participants | 30 | 166 |
| Count of Participants [Participants] |
28
93.3%
|
162
95.3%
|
| Title | Number of Participants With Late Technical Success |
|---|---|
| Description | Late technical success (through 12 months) is the absence of device movement >10mm related to anatomical landmarks or any migration leading to symptoms or requiring therapy; absence of stent occlusion by thrombosis or restenosis, defined as reduction in treated segment lumen more than 50% from the post-procedure vessel lumen diameter as measured by post-procedural venogram or DUS and maintenance of structural integrity, defined as the absence of pinching (focal compression), kinking (stent doubling or bending upon itself) that results in >50% diameter reduction of the stent, recoil (poor radial resistive force) or absence of fractures . |
| Time Frame | 12 months post-intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| For the feasibility cohort, month 12 outcomes were available for 22 subjects. For the pivotal cohort, only 127 subjects had a 12-month venogram and/or stent fracture assessment. |
| Arm/Group Title | VICI Stent Implantation - Feasibility | VICI Stent Implantation - Pivotal |
|---|---|---|
| Arm/Group Description | Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System | Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System |
| Measure Participants | 22 | 127 |
| Count of Participants [Participants] |
16
53.3%
|
97
57.1%
|
| Title | Change in the Quality of Life (Chronic Venous Insufficiency Questionnaire)(CIVIQ2)) |
|---|---|
| Description | The overall change in CIVIQ2 scores for the study patients, calculated using the mean scores at baseline and 12-months. This instrument is scored from 20 to 100 points with lower scores indicating a lesser impact on health. |
| Time Frame | Baseline and 12 months post-intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| For the feasibility cohort, three subjects did not have Month 12 CIVIQ-2 results. For the pivotal cohort, results for 24 subjects from a single US center are not included due to data integrity issues. Also, 11 subjects did not have a Month 12 visit and 2 subjects did not complete the CIVIQ forms. |
| Arm/Group Title | VICI Stent Implantation - Feasibility | VICI Stent Implantation - Pivotal |
|---|---|---|
| Arm/Group Description | Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System | Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System |
| Measure Participants | 27 | 133 |
| Mean (95% Confidence Interval) [units on a scale] |
-15.4
|
-13.1
|
| Title | Number of Participants With Estimated Primary-Assisted Patency |
|---|---|
| Description | Primary-assisted patency is defined as freedom from occlusion regardless of whether an intervention (subsequent to the index procedure) was performed. |
| Time Frame | 12 months post-intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| For the feasibility cohort, only 21 subjects had known outcomes. For the pivotal cohort, only 126 subjects had known outcomes. |
| Arm/Group Title | VICI Stent Implantation - Feasibility | VICI Stent Implantation - Pivotal |
|---|---|---|
| Arm/Group Description | Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System | Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System |
| Measure Participants | 21 | 126 |
| Count of Participants [Participants] |
20
66.7%
|
117
68.8%
|
| Title | Number of Participants With Estimated Secondary Patency |
|---|---|
| Description | Secondary patency is defined as freedom from "permanent" loss of patency determined through last follow-up (irrespective of the number of interventions). |
| Time Frame | 36 months post-intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| For the feasibility cohort, 13 subjects had known outcomes. For the pivotal cohort, 97 subjects had known outcomes. |
| Arm/Group Title | VICI Stent Implantation - Feasibility | VICI Stent Implantation - Pivotal |
|---|---|---|
| Arm/Group Description | Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System Veniti Vici™ Venous Stent System | Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System Veniti Vici™ Venous Stent System |
| Measure Participants | 13 | 97 |
| Count of Participants [Participants] |
13
43.3%
|
93
54.7%
|
Adverse Events
| Time Frame | Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | VICI Stent Implantation - Feasibility | VICI Stent Implantation - Pivotal | ||
| Arm/Group Description | Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System | Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System | ||
All Cause Mortality |
||||
| VICI Stent Implantation - Feasibility | VICI Stent Implantation - Pivotal | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/30 (0%) | 4/170 (2.4%) | ||
Serious Adverse Events |
||||
| VICI Stent Implantation - Feasibility | VICI Stent Implantation - Pivotal | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 14/30 (46.7%) | 86/170 (50.6%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 0/30 (0%) | 0 | 2/170 (1.2%) | 3 |
| Sickle cell anaemia with crisis | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Thrombocytopenia | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Haemorrhagic anaemia | 0/30 (0%) | 0 | 2/170 (1.2%) | 2 |
| White blood cell disorder | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Cardiac disorders | ||||
| Acute myocardial infarction | 0/30 (0%) | 0 | 2/170 (1.2%) | 2 |
| Bradycardia | 0/30 (0%) | 0 | 2/170 (1.2%) | 2 |
| Cardiac failure congestive | 0/30 (0%) | 0 | 2/170 (1.2%) | 2 |
| Pericardial effusion | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Ventricular tachycardia | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Atrial fibrillation | 0/30 (0%) | 0 | 1/170 (0.6%) | 3 |
| Acute coronary syndrome | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Angina pectoris | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Right ventricular failure | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Sinus node dysfunction | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Gastrointestinal disorders | ||||
| Internal hernia | 1/30 (3.3%) | 1 | 0/170 (0%) | 0 |
| Gastric perforation | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Ileus | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Melaena | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Rectal haemorrhage | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Abdominal pain | 1/30 (3.3%) | 1 | 0/170 (0%) | 0 |
| Rectal prolapse | 0/30 (0%) | 0 | 1/170 (0.6%) | 2 |
| Anal prolapse | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Dysphagia | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Intestinal ischaemia | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Intestinal obstruction | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Intestinal prolapse | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Pancreatic cyst | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Umbilical hernia | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| General disorders | ||||
| Vascular stent thrombosis | 4/30 (13.3%) | 6 | 10/170 (5.9%) | 14 |
| Vascular stent restenosis | 2/30 (6.7%) | 2 | 8/170 (4.7%) | 9 |
| Vascular stent stenosis | 2/30 (6.7%) | 3 | 4/170 (2.4%) | 5 |
| Vascular stent occlusion | 1/30 (3.3%) | 1 | 2/170 (1.2%) | 2 |
| Stenosis | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Oedema peripheral | 0/30 (0%) | 0 | 3/170 (1.8%) | 4 |
| Peripheral swelling | 1/30 (3.3%) | 1 | 1/170 (0.6%) | 1 |
| Puncture site haemorrhage | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Hepatobiliary disorders | ||||
| Cholelithiasis | 1/30 (3.3%) | 1 | 2/170 (1.2%) | 2 |
| Immune system disorders | ||||
| Allergy to plants | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Infections and infestations | ||||
| Sepsis | 0/30 (0%) | 0 | 6/170 (3.5%) | 15 |
| Urinary tract infection | 0/30 (0%) | 0 | 4/170 (2.4%) | 4 |
| Cellulitis | 0/30 (0%) | 0 | 8/170 (4.7%) | 11 |
| Parotitis | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Pneumonia | 1/30 (3.3%) | 1 | 1/170 (0.6%) | 1 |
| Abdominal wall abscess | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Arthritis bacterial | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Arthritis infective | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Erysipelas | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Infection | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Oral candidiasis | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Osteomyelitis | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Pneumonia bacterial | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Urosepsis | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Injury, poisoning and procedural complications | ||||
| Vascular pseudoaneurysm | 1/30 (3.3%) | 1 | 1/170 (0.6%) | 1 |
| Vascular access site hemorrhage | 1/30 (3.3%) | 1 | 0/170 (0%) | 0 |
| Vascular access site hematoma | 1/30 (3.3%) | 1 | 0/170 (0%) | 0 |
| Vascular pseudoaneurysm ruptured | 0/30 (0%) | 0 | 0/170 (0%) | 0 |
| Hip fracture | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Wound | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Post procedural haematoma | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Delayed haemolytic transfusion reaction | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Gastrointestinal anastomotic leak | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Gastrointestinal stoma complication | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Joint dislocation | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Post procedural complication | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Rib fracture | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Spinal compression fracture | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Investigations | ||||
| International normalized ratio decreased | 1/30 (3.3%) | 1 | 0/170 (0%) | 0 |
| Blood culture positive | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Haemoglobin decreased | 0/30 (0%) | 0 | 3/170 (1.8%) | 3 |
| Specific gravity urine abnormal | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Haematocrit decreased | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Metabolism and nutrition disorders | ||||
| Diabetic ketoacidosis | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Electrolyte imbalance | 0/30 (0%) | 0 | 2/170 (1.2%) | 2 |
| Hypokalaemia | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| Back pain | 0/30 (0%) | 0 | 5/170 (2.9%) | 5 |
| Pain in extremity | 0/30 (0%) | 0 | 3/170 (1.8%) | 5 |
| Rhabdomyolysis | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Arthralgia | 0/30 (0%) | 0 | 2/170 (1.2%) | 2 |
| Groin pain | 0/30 (0%) | 0 | 1/170 (0.6%) | 2 |
| Bursitis | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Flank pain | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Osteoarthritis | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Synovial cyst | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Leukaemia | 0/30 (0%) | 0 | 1/170 (0.6%) | 3 |
| Plasmacytoma | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Nervous system disorders | ||||
| Sciatica | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Seizure | 1/30 (3.3%) | 1 | 3/170 (1.8%) | 3 |
| Cerebral haemorrhage | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Cerebrovascular accident | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Encephalopathy | 0/30 (0%) | 0 | 2/170 (1.2%) | 2 |
| Encephalomalacia | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Dizziness | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Nerve root compression | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Syncope | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Thecal sac compression | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Product Issues | ||||
| Stent malfunction | 2/30 (6.7%) | 2 | 2/170 (1.2%) | 2 |
| Device malfunction | 1/30 (3.3%) | 1 | 0/170 (0%) | 0 |
| Device dislocation | 1/30 (3.3%) | 1 | 3/170 (1.8%) | 3 |
| Device occlusion | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Psychiatric disorders | ||||
| Mental status changes | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Renal and urinary disorders | ||||
| Renal vein compression | 1/30 (3.3%) | 1 | 0/170 (0%) | 0 |
| Chronic kidney disease | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Acute kidney injury | 0/30 (0%) | 0 | 2/170 (1.2%) | 2 |
| Reproductive system and breast disorders | ||||
| Pelvic congestion | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Pelvic haematoma | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Asthma | 1/30 (3.3%) | 1 | 0/170 (0%) | 0 |
| Pulmonary embolism | 1/30 (3.3%) | 1 | 3/170 (1.8%) | 3 |
| Respiratory depression | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Respiratory failure | 0/30 (0%) | 0 | 2/170 (1.2%) | 3 |
| Chronic obstructive pulmonary disease | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Pneumonia aspiration | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Skin and subcutaneous tissue disorders | ||||
| Skin ulcer | 0/30 (0%) | 0 | 3/170 (1.8%) | 3 |
| Surgical and medical procedures | ||||
| Venous angioplasty | 4/30 (13.3%) | 7 | 9/170 (5.3%) | 11 |
| Venous stent insertion | 3/30 (10%) | 3 | 2/170 (1.2%) | 2 |
| Hysterectomy | 1/30 (3.3%) | 1 | 0/170 (0%) | 0 |
| Thrombolysis | 0/30 (0%) | 0 | 4/170 (2.4%) | 4 |
| Vascular stent insertion | 0/30 (0%) | 0 | 2/170 (1.2%) | 2 |
| Angioplasty | 0/30 (0%) | 0 | 2/170 (1.2%) | 2 |
| Thrombectomy | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Varicose vein operation | 2/30 (6.7%) | 2 | 4/170 (2.4%) | 4 |
| Hip arthroplasty | 1/30 (3.3%) | 1 | 1/170 (0.6%) | 1 |
| Myomectomy | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Hernia repair | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Transfusion | 0/30 (0%) | 0 | 2/170 (1.2%) | 2 |
| Interventional procedure | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Cholecystectomy | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Catheterisation venous | 1/30 (3.3%) | 1 | 0/170 (0%) | 0 |
| Atherectomy | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Colostomy | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Coronary arterial stent insertion | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Knee arthroplasty | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Neurolysis | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Peripheral artery angioplasty | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Vascular disorders | ||||
| Arteriovenous fistula | 1/30 (3.3%) | 1 | 2/170 (1.2%) | 2 |
| Varicose vein | 0/30 (0%) | 0 | 2/170 (1.2%) | 2 |
| Aneurysm ruptured | 1/30 (3.3%) | 1 | 0/170 (0%) | 0 |
| Deep vein thrombosis | 2/30 (6.7%) | 2 | 17/170 (10%) | 24 |
| Vena cava thrombosis | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Venous stenosis | 0/30 (0%) | 0 | 2/170 (1.2%) | 3 |
| Venous occlusion | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Aortic aneurysm | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Varicose ulceration | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Vascular compression | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Peripheral venous disease | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Phlebitis | 0/30 (0%) | 0 | 1/170 (0.6%) | 2 |
| Paget-Schroetter syndrome | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Venous thrombosis | 1/30 (3.3%) | 1 | 2/170 (1.2%) | 2 |
| Intermittent claudication | 1/30 (3.3%) | 1 | 0/170 (0%) | 0 |
| Pelvic venous thrombosis | 0/30 (0%) | 0 | 3/170 (1.8%) | 4 |
| Peripheral arterial occlusive disease | 0/30 (0%) | 0 | 2/170 (1.2%) | 2 |
| Haematoma | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Haemorrhage | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Hypertensive crisis | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Peripheral artery occlusion | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Post thrombotic syndrome | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Vasculitis | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| VICI Stent Implantation - Feasibility | VICI Stent Implantation - Pivotal | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 14/30 (46.7%) | 102/170 (60%) | ||
| Blood and lymphatic system disorders | ||||
| Antiphospholipid syndrome | 1/30 (3.3%) | 1 | 0/170 (0%) | 0 |
| Anaemia | 0/30 (0%) | 0 | 2/170 (1.2%) | 2 |
| Lymphadenopathy | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Cardiac disorders | ||||
| Bradycardia | 1/30 (3.3%) | 1 | 0/170 (0%) | 0 |
| Palpitations | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Cyanosis | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Endocrine disorders | ||||
| Thyroid mass | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Eye disorders | ||||
| Vision blurred | 1/30 (3.3%) | 1 | 0/170 (0%) | 0 |
| Blindness | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Gastrointestinal disorders | ||||
| Abdominal distension | 1/30 (3.3%) | 1 | 0/170 (0%) | 0 |
| Nausea | 1/30 (3.3%) | 1 | 4/170 (2.4%) | 4 |
| Abdominal pain | 0/30 (0%) | 0 | 5/170 (2.9%) | 5 |
| Vomiting | 0/30 (0%) | 0 | 2/170 (1.2%) | 2 |
| Ascites | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Crohn's disease | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Diarrhaea haemorrhagic | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Gastritis | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Gastrointestinal haemorrhage | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Bile acid malabsorption | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Mouth haemorrhage | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| General disorders | ||||
| Hypothermia | 1/30 (3.3%) | 1 | 0/170 (0%) | 0 |
| Tenderness | 1/30 (3.3%) | 1 | 0/170 (0%) | 0 |
| Adverse drug reaction | 1/30 (3.3%) | 1 | 0/170 (0%) | 0 |
| Non-cardiac chest pain | 1/30 (3.3%) | 1 | 1/170 (0.6%) | 1 |
| Vascular stent thrombosis | 1/30 (3.3%) | 1 | 5/170 (2.9%) | 5 |
| Complication associated with device | 1/30 (3.3%) | 1 | 0/170 (0%) | 0 |
| Peripheral swelling | 0/30 (0%) | 0 | 16/170 (9.4%) | 17 |
| Chest pain | 0/30 (0%) | 0 | 2/170 (1.2%) | 2 |
| Oedema peripheral | 0/30 (0%) | 0 | 3/170 (1.8%) | 3 |
| Chills | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Facial pain | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Fatigue | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Influenza like illness | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Injection site bruising | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Injection site pain | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Oedema | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Pain | 0/30 (0%) | 0 | 2/170 (1.2%) | 2 |
| Vascular stent occlusion | 0/30 (0%) | 0 | 3/170 (1.8%) | 3 |
| Puncture site hemorrhage | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Vascular stent stenosis | 0/30 (0%) | 0 | 2/170 (1.2%) | 2 |
| Localized oedema | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Vascular stent restenosis | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Hepatobiliary disorders | ||||
| Hepatitis | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Immune system disorders | ||||
| Drug hypersensitivity | 0/30 (0%) | 0 | 3/170 (1.8%) | 3 |
| Infections and infestations | ||||
| Lower respiratory tract infection | 1/30 (3.3%) | 1 | 0/170 (0%) | 0 |
| Pharyngitis | 1/30 (3.3%) | 1 | 0/170 (0%) | 0 |
| Infected skin ulcer | 0/30 (0%) | 0 | 2/170 (1.2%) | 2 |
| Pneumonia | 0/30 (0%) | 0 | 2/170 (1.2%) | 2 |
| Cellulitis | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Parotitis | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Postoperative wound infection | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Sepsis | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Tinea cruris | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Infected cyst | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Respiratory tract infection | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Infected varicose vein | 0/30 (0%) | 0 | 1/170 (0.6%) | 2 |
| Urinary tract infection | 0/30 (0%) | 0 | 2/170 (1.2%) | 2 |
| Fungal skin infection | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Root canal infection | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Injury, poisoning and procedural complications | ||||
| Fall | 1/30 (3.3%) | 1 | 3/170 (1.8%) | 3 |
| Laceration | 1/30 (3.3%) | 1 | 0/170 (0%) | 0 |
| Peripheral nerve injury | 1/30 (3.3%) | 1 | 0/170 (0%) | 0 |
| Contusion | 1/30 (3.3%) | 1 | 0/170 (0%) | 0 |
| Thermal burn | 1/30 (3.3%) | 1 | 0/170 (0%) | 0 |
| Post procedural hematoma | 1/30 (3.3%) | 1 | 0/170 (0%) | 0 |
| Foot fracture | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Hand fracture | 0/30 (0%) | 0 | 2/170 (1.2%) | 2 |
| Hip fracture | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Ligament sprain | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Tendon rupture | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Procedural headache | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Vascular access site haemorrhage | 0/30 (0%) | 0 | 2/170 (1.2%) | 2 |
| Humerus fracture | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Post procedural constipation | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Vascular access site hemorrhage | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Vascular access site pain | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Investigations | ||||
| Hemoglobin decreased | 1/30 (3.3%) | 1 | 0/170 (0%) | 0 |
| Oxygen saturation decreased | 1/30 (3.3%) | 1 | 1/170 (0.6%) | 1 |
| Weight increased | 1/30 (3.3%) | 1 | 1/170 (0.6%) | 1 |
| Antiphospholipid antibodies positive | 1/30 (3.3%) | 1 | 0/170 (0%) | 0 |
| Blood creatinine increased | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| International normalised ratio increased | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Nuclear magnetic resonance imaging brain abnormal | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Venous pressure increased | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Cyst aspiration | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Metabolism and nutrition disorders | ||||
| Dehydration | 1/30 (3.3%) | 1 | 1/170 (0.6%) | 1 |
| Hyponatremia | 1/30 (3.3%) | 1 | 0/170 (0%) | 0 |
| Hyperglycaemia | 0/30 (0%) | 0 | 2/170 (1.2%) | 2 |
| Hyperkalaemia | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Hyperglycemia | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| Muscle spasms | 2/30 (6.7%) | 2 | 0/170 (0%) | 0 |
| Back pain | 2/30 (6.7%) | 3 | 15/170 (8.8%) | 16 |
| Pain in extremity | 2/30 (6.7%) | 3 | 17/170 (10%) | 21 |
| Costochondritis | 1/30 (3.3%) | 1 | 0/170 (0%) | 0 |
| Groin pain | 1/30 (3.3%) | 1 | 2/170 (1.2%) | 2 |
| Tendon pain | 1/30 (3.3%) | 1 | 0/170 (0%) | 0 |
| Arthralgia | 0/30 (0%) | 0 | 5/170 (2.9%) | 5 |
| Musculoskeletal chest pain | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Osteoarthritis | 0/30 (0%) | 0 | 3/170 (1.8%) | 3 |
| Osteoporotic fracture | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Rheumatoid arthritis | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Synovial cyst | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Limb discomfort | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Joint range of motion decreased | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Musculoskeletal pain | 0/30 (0%) | 0 | 2/170 (1.2%) | 2 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Basal cell carcinoma | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Benign breast neoplasm | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Melanocytic naevus | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Prostate cancer | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Nervous system disorders | ||||
| Lethargy | 1/30 (3.3%) | 1 | 0/170 (0%) | 0 |
| Paraesthesia | 1/30 (3.3%) | 1 | 3/170 (1.8%) | 3 |
| Syncope | 1/30 (3.3%) | 1 | 1/170 (0.6%) | 1 |
| Dizziness | 0/30 (0%) | 0 | 2/170 (1.2%) | 2 |
| Headache | 0/30 (0%) | 0 | 2/170 (1.2%) | 2 |
| Amnesia | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Burning sensation | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Carotid artery aneurysm | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Facial paralysis | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Loss of consciousness | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Seizure | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| VIth nerve paralysis | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Pregnancy, puerperium and perinatal conditions | ||||
| Blighted ovum | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Product Issues | ||||
| Device dislocation | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Stent malfunction | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Psychiatric disorders | ||||
| Phonophobia | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Drug use disorder | 0/30 (0%) | 0 | 2/170 (1.2%) | 7 |
| Anxiety | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Renal and urinary disorders | ||||
| Haematuria | 0/30 (0%) | 0 | 3/170 (1.8%) | 3 |
| Nephrolithiasis | 0/30 (0%) | 0 | 2/170 (1.2%) | 2 |
| Renal cyst | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Acute kidney injury | 0/30 (0%) | 0 | 2/170 (1.2%) | 2 |
| Reproductive system and breast disorders | ||||
| Vaginal haemorrhage | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Pelvic congestion | 0/30 (0%) | 0 | 1/170 (0.6%) | 2 |
| Menorrhagia | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Scrotal pain | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Bronchiectasis | 1/30 (3.3%) | 1 | 0/170 (0%) | 0 |
| Epistaxis | 1/30 (3.3%) | 1 | 3/170 (1.8%) | 3 |
| Productive cough | 1/30 (3.3%) | 1 | 0/170 (0%) | 0 |
| Pulmonary embolism | 1/30 (3.3%) | 1 | 0/170 (0%) | 0 |
| Dyspnaea | 0/30 (0%) | 0 | 3/170 (1.8%) | 4 |
| Atelectasis | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Cough | 0/30 (0%) | 0 | 1/170 (0.6%) | 2 |
| Haemoptysis | 0/30 (0%) | 0 | 2/170 (1.2%) | 2 |
| Pulmonary congestion | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Respiratory distress | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Bronchospasm | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Dyspnoea exertional | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Skin and subcutaneous tissue disorders | ||||
| Skin ulcer | 0/30 (0%) | 0 | 3/170 (1.8%) | 4 |
| Alopecia | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Blister | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Decubitus ulcer | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Dermatitis contact | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Hyperhidrosis | 0/30 (0%) | 0 | 1/170 (0.6%) | 2 |
| Rash | 0/30 (0%) | 0 | 2/170 (1.2%) | 3 |
| Skin discolouration | 0/30 (0%) | 0 | 2/170 (1.2%) | 3 |
| Rash pruritic | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Social circumstances | ||||
| Homeless | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Surgical and medical procedures | ||||
| Abortion induced | 1/30 (3.3%) | 1 | 0/170 (0%) | 0 |
| Venous angioplasty | 0/30 (0%) | 0 | 3/170 (1.8%) | 3 |
| Thrombolysis | 0/30 (0%) | 0 | 2/170 (1.2%) | 2 |
| Varicose vein operation | 0/30 (0%) | 0 | 2/170 (1.2%) | 2 |
| Joint fluid drainage | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Vena cava filter insertion | 0/30 (0%) | 0 | 1/170 (0.6%) | 2 |
| Vena cava filter removal | 0/30 (0%) | 0 | 1/170 (0.6%) | 2 |
| Vascular stent insertion | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Venous stent insertion | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Varicose vein | 0/30 (0%) | 0 | 2/170 (1.2%) | 2 |
| Vascular disorders | ||||
| Hyperemia | 1/30 (3.3%) | 1 | 0/170 (0%) | 0 |
| Hypotension | 1/30 (3.3%) | 1 | 2/170 (1.2%) | 2 |
| Thrombosis | 1/30 (3.3%) | 1 | 1/170 (0.6%) | 1 |
| Hematoma | 0/30 (0%) | 0 | 2/170 (1.2%) | 2 |
| Haematoma | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Deep vein thrombosis | 0/30 (0%) | 0 | 2/170 (1.2%) | 2 |
| Peripheral coldness | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Hemorrhage | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Peripheral venous disease | 0/30 (0%) | 0 | 16/170 (9.4%) | 25 |
| Phlebitis | 0/30 (0%) | 0 | 2/170 (1.2%) | 2 |
| Axillary vein thrombosis | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Hypertension | 0/30 (0%) | 0 | 2/170 (1.2%) | 2 |
| Lymphoedema | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Thrombophlebitis superficial | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Vasculitis | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Post thrombotic syndrome | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Subclavian vein thrombosis | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Peripheral arterial occlusive disease | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
| Varicose ulceration | 0/30 (0%) | 0 | 1/170 (0.6%) | 2 |
| Vascular insufficiency | 0/30 (0%) | 0 | 1/170 (0.6%) | 1 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Nancy O'Connell, Sr. Clinical Research Manager |
|---|---|
| Organization | Boston Scientific |
| Phone | 763-494-2706 |
| nancy.oconnell@bsci.com |
Responsible Party:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT02112877
Other Study ID Numbers:
- STE-HUM-004P
- STE-HUM-007P
First Posted:
Apr 14, 2014
Last Update Posted:
Apr 15, 2021
Last Verified:
Mar 1, 2021