Claudication, Peripheral Arterial Disease
Conditions
Keywords
Peripheral arterial disease, claudication, stent, VISI-Pro, Iliac artery
Brief summary
The VISIBILITY Iliac study is a prospective, multi-center, non-randomized study confirming the safety and effectiveness of stenting using the Visi-Pro™ Balloon Expandable Stent System for the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.
Interventions
DEVICEVisi-Pro™ Balloon Expandable Stent System
Implantation of one or more study devices in the common and/or external iliac artery.
Sponsors
Medtronic Endovascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient has claudication as defined by a Rutherford Clinical Category Score of 2, 3 or 4. * Evidence of ≥ 50% stenosis, restenosis or occlusion of target lesion(s) located in the common iliac artery and/or external iliac artery. * Willing to comply with all follow-up evaluations at the specified times. * Provides written informed consent prior to enrollment in the study.
Exclusion criteria
* Previous implantation of stent(s) in the target vessel. * Received endovascular treatment of the target lesion within six months prior to the index procedure. * Known hypersensitivity to contrast material that cannot be adequately pretreated. * Known hypersensitivity to 316L stainless Steel. * Life expectancy of less than 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Event Rate at 9 Months | 9 months | The Major Adverse Event rate at 9 months is defined as a composite of periprocedural death, in-hospital MI, clinically-driven target lesion revascularization and amputation of the treated limb through 9 months postprocedure. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Visi-Pro™ Balloon Expandable Stent System The objective of the study is to confirm the safety and effectiveness of the Visi-Pro stent in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.
Visi-Pro™ Balloon Expandable Stent System: Implantation of one or more study devices in the common and/or external iliac artery. | 75 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 3 |
| Overall Study | Missed Visit | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Visi-Pro™ Balloon Expandable Stent System |
|---|---|
| Age, Continuous | 64.2 years STANDARD_DEVIATION 8.9 |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 22 / 75 |
| serious Total, serious adverse events | 38 / 75 |
Outcome results
Primary
Major Adverse Event Rate at 9 Months
The Major Adverse Event rate at 9 months is defined as a composite of periprocedural death, in-hospital MI, clinically-driven target lesion revascularization and amputation of the treated limb through 9 months postprocedure.
Time frame: 9 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Visi-Pro™ Balloon Expandable Stent System | Major Adverse Event Rate at 9 Months | 4.0 percentage of participants |