The primary objective of this trial is to demonstrate the superiority of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis for primary patency when compared to bare metal stenting for the treatment of patients with complex iliac occlusive…
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Patency through 1 year
Secondary outcome
1. Technical success at final angiography
2. Acute procedural success through vascular closure
3. Clinical success through 1 month
4. Hemodynamic status through 5 years
5. Change in EQ-5D-5L through 5 years
6. Change in WIQ through 5 years
7. Primary patency through 5 years
8. Freedom from binary restenosis through 5 years
9. Primary assisted patency through 5 years
10. Secondary patency through 5 years
11. Freedom from target lesion revascularization through 5 years
12. Cumulative reintervention rate through 5 years
13. Freedom from clinically driven target lesion revascularization through 5
years
14. Amputation-free survival through 5 years
15. Survival through 5 years
16. Change in Rutherford Category through 5 years
Background summary
The GORE VBX FORWARD Clinical Study is prospective, multicenter,
randomized-controlled, Post-Marketing clinical study of a CE Marked Medical
Device- The GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX Stent
Graft).
With reduced blood flow in the iliac arteries and they may be partially or
entirely obstructed, typically by atherosclerotic plaques, also called
Peripheral Arterial Disease. The reduced blood flow is causing symptoms such as
pain and this may cause leg pain when walking (claudication) and other
symptoms.
In order to restore the blood flow through arteries, the Study Doctor needs to
implant a stent (tiny tube) in the diseased artery in order to keep the vessel
open.
The first device, the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX
Device) received initial CE marking in August 2017 and is used to treat
Peripheral Artery Disease "Study Device" manufactured by sponsor.
The second device is called a Bare Metal Stent (BMS) the *Control Device*. This
type of device is manufactured by other companies and is approved (CE marking)
to treat Peripheral Artery Disease.
This research study will look at how effective the Study Device is compared to
Control Device and how it works for Peripheral Artery Disease from the
procedure up to 5 years. To collect clinical data about safety and performance
of the medical devices after the implant and throughout the device functional
lifetime.
Study objective
The primary objective of this trial is to demonstrate the superiority of the
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis for primary patency when
compared to bare metal stenting for the treatment of patients with complex
iliac occlusive disease.
Study design
Prospective, multicenter, randomized, controlled clinical trial.
Study burden and risks
Subject*s participation in this study will last 5 years and consists of a
screening period, procedure and discharge and a follow-up period. During the FU
period, subjects will need to visit the study site 7 FU visits. Participants
will be subjected to additional ABI test.
Unanticipated risks may occur, there are possible risks and inconveniences
involved when participating in any research study.
N. Fourth Street 1500
Flagstaff AZ 86004
US
N. Fourth Street 1500
Flagstaff AZ 86004
US
Listed location countries
Age
Inclusion criteria
• Patient has symptomatic claudication or rest pain, or minor tissue loss
(Rutherford Categories 2-5)
• Patient has de novo or restenotic lesion(s) found in the common and/or
external iliac artery(ies)
• Patient has: Unilateral or bilateral single or multiple lesions (>50%
stenosis or chronic total occlusion) each between 4 and 11 cm in length
• Patient has a target vessel diameter visually estimated to be approximately
between 5 mm and 13 mm
• Patient has a sufficient (<50% stenotic) common femoral artery and at least
one sufficient (<50% stenotic) femoral artery (deep or superficial).
• Patient has at least one sufficient (<50% stenotic) infrapopliteal run-off
vessel.
Exclusion criteria
• Patient has a lesion requiring drug-coated balloon angioplasty, atherectomy,
lithotripsy, or any ablative device to facilitate stent delivery
• Patient has an abdominal aortic artery occlusion or aneurysm
• Patient has isolated common iliac artery stenosis that can be treated with a
single device (i.e., common iliac artery stenosis that does not require kissing
stents or extended into the external iliac artery).
• Patient has outflow disease that requires concomitant interventions (i.e.,
common femoral endarterectomy or femoral / tibial revascularization)
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 | NCT05811364 |
| CCMO | NL84685.091.23 |