The objective of this study is to assess the safety and efficacy of the Veniti Vici* Venous Stent System in achieving patency of the target venous lesion through 36 months in patients who present with clinically significant chronic non-malignant…
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary efficacy endpoint for this study will be the primary patency rate
at 12 months post-intervention, defined as freedom from occlusion by thrombosis
AND freedom from surgical or endovascular intervention on target vessel segment
which are found to have re-stenosis or stent occlusion to maintain patency AND
freedom from in-stent stenosis more than 50% by venogram and/or DUS .
The primary safety endpoint for this study will be a composite endpoint of any
major adverse event within 30 days, as adjudicated by a Clinical Events
Committee. Major Adverse Events include:
* Procedure or device-related death
* Procedure related bleeding requiring surgical or endovascular intervention or
blood transfusion >=2 units
* Procedure related arterial or venous injury requiring surgical or
endovascular intervention
* Device or procedure related acute DVT
* Clinically significant pulmonary embolism defined as being symptomatic with
chest pain, hemoptysis, dyspnea, hypoxia etc. AND be documented on CT
* Embolization of stentt
Secondary outcome
The formal secondary endpoint for this study will be a binary response variable
based on an improvement in VCSS by at least 50% at 12 months post-intervention.
Ancillary Analyses
Procedural Endpoints
* Procedural technical success, defined as achievement of a final residual
diameter stenosis of <=50% as measured by venogram without skipped lesion areas
with placement of the study device alone with or without post-stenting balloon
dilation
* Lesion success defined as achievement of <=50% residual diameter stenosis
using any percutaneous method (including use of non-study devices)
* Procedural success defined as procedural technical success without the
occurrence of major adverse event between the index procedure and discharge
Late technical success (through 12 months) defined as:
* Absence of migration from site of original placement such that target lesion
is uncovered or results in separation of overlapping stents
* Absence of stent embolization
* Achievement of primary patency
* Structural integrity, defined as the absence of:
* Pinching, defined as focal compression of the stent with > 50% diameter
reduction of the stent
* Kinking, defined as >50% diameter reduction of the stent with the stent
doubling or bending on itself
* Recoil, defined a poor radial resistance to diffuse collapse, which results
in >50% diameter reduction of the stent (i.e., stent diameters obtained
throughout the study period as compared to the final stent diameter after
insertion measured by DUS or venogram).
* Fracture(s)
Fractures will be assessed as per Jaff, et al. 1 (See Appendix 3.) Data to be
collected for each fracture identified includes:
o Limb (right or left)
o Venous segment(s) where fractures are located
o Overlapping versus non-overlapping
o Type of fracture (Type I, II, III, IV)
Background summary
Chronic venous disorders (CVD) have a significant social and economic cost,
impacting an estimated 50% of Western populations, and consuming an estimated
2-3% of healthcare budgets. Percutaneous stenting of the iliofemoral venous
outflow system has developed over the past decade as the *method of choice* to
manage chronic venous obstruction. The procedure can be performed with low
morbidity, no mortality, long-term high patency rate, and low rate of in-stent
restenosis. It has replaced bypass surgery as the primary treatment.
Study objective
The objective of this study is to assess the safety and efficacy of the Veniti
Vici* Venous Stent System in achieving patency of the target venous lesion
through 36 months in patients who present with clinically significant chronic
non-malignant obstruction of the iliofemoral venous outflow tract.
Study design
Prospective, multicenter, 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.
Intervention
Percutaneous placement of the Veniti Vici Venous Stent System.
Study burden and risks
Possible complications that the subject may experience from participating in
this study include the following:
• A narrowing or scarring of the vein
• Complications (bleeding, bruising, pain, tenderness) where the study doctor
enters your vein
• Damage to the vein that the study doctor punctures, or damage to the nearby
artery and nerves
• A blood clot
• An allergic reaction to the dye used during the procedure
• A blood clot that travels to your lung
• Problems with kidney function
• Death
• An air bubble or other object carried in the bloodstream
• Emergency surgery to repair a damaged vein
• Higher or lower blood pressure
• Infection
• An infection in your lungs called pneumonia
• A collapsed lung
• A large collection of blood that forms as the result of a leaking hole in an
artery
• Swelling of the vein caused by a blood clot
• A heart attack
• Chest Pain
• Movement of the investigational device from the original location where the
study doctor placed it
• Increased bleeding risk from medications used to prevent blood clots
This study involves exposure to a very small amount of radiation. As part of
everyday living, everyone is exposed to naturally occurring background
radiation and receives a dose of about 2 millisieverts (mSv) each year. The
dose from this study is comparable to the dose received from many diagnostic
medical X-ray and nuclear medicine procedures. At this dose level, no harmful
effects of radiation have been demonstrated, as any effect is too small to
measure.
Pregnant and breastfeeding women are excluded from this study. This applies to
the entire study. It is not known what the consequences of participating in the
study are to your unborn child.
The study doctor will discuss the procedure and the potential complications
extensively discuss with the patient.
Benefits
There is no guarantee that one will benefit from participating in this study.
Potential benefits for patients in whom the device is implanted, include the
following:
• improves their condition because blood can flow through a previously
obstructed artery
• minimally invasive
• short-term hospital
This research may also mean an improvement for the future treatment of veuneuze
failure at the height of the vein iliofemorale.
1610 Des Peres Road Suite 385
St. Louis MO 63131
US
1610 Des Peres Road Suite 385
St. Louis MO 63131
US
Listed location countries
Age
Inclusion criteria
1. Age >=18 years
2. Willing and capable of complying with all follow-up evaluations at the specified times
3. Able and willing to provide written informed consent prior to study specific procedures
4. 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 as measured by venogram
5. Clinically significant venous obstruction defined as meeting at least one of the following clinical indicators:
• Clinical severity class of CEAP classification >=3 (See Appendix 4.)
• VCSS Pain Score >=2 (See Appendix 7.)
6. Negative pregnancy test in females of child-bearing potential
7. Intention to stent the target lesion only with the Veniti Vici* Venous Stent
Exclusion criteria
1. Presence or history of clinically significant pulmonary emboli within 6 months prior to enrollment.
2. Venous obstruction that extends into the inferior vena cava
3. 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
4. Life expectancy <12 months
5. Female of childbearing potential who is pregnant or plans to become pregnant during the duration of the clinical study
6. Uncontrolled or active coagulopathy or known uncorrectable bleeding diathesis
a. Uncorrected INR >=2.0 or aPTT >=1.5 X normal local lab value
b. Platelet count <100,000
c. Anti-platelet therapy except for ASA (patients on clopidogrel, prasugrel who cannot discontinue for seven days prior to the procedure are excluded)
7. Uncorrected hemoglobin of <=9 g/dL
8. Patients with an estimated glomerular filtration rate (eGFR) <30 mL/min
9. Known hypersensitivity to nickel or titanium
10. Contrast agent allergy that cannot be managed adequately with pre-medication
11. Intended concurrent thrombolysis or thrombectomy procedure OR intended or planned (within 30 days) adjuvant procedure such as creation of temporary AV fistula, placement of IVC filter, endovenectomy or saphenous vein ablation
12. Current or recent (within 30 days) active participation in another drug or device clinical trial
13. Patient judged to be a poor candidate by the primary investigator
14. Patient who does not consent to either the study treatment or study procedures, including follow-up visits
15. Patients who have had any prior surgical or endovascular procedure of the target vessel;Intra-procedural
1. Patients in whom the lesions cannot be traversed with a guide wire. These patients will not be enrolled and will not count against the study sample size.
2. Patients where the obstruction extends into the inferior vena cava. These patients will not be enrolled and will not count against the study sample size.
3. Patients whose vein diameters are not within limits stated in current Instructions for Use as determined by venogram. These patients will not be enrolled and will not count against the study sample size.
4. Patients who do not meet the venogram binary stenosis definition above, as determined by the treating physician.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02112877 |
| CCMO | NL49034.091.14 |