Claudication, Peripheral Arterial Disease
Conditions
Keywords
Peripheral arterial disease, claudication, stent, EverFlex, GPS, Iliac Artery
Brief summary
The DURABILITY Iliac study is a prospective, multi-center, non-randomized study confirming the safety and effectiveness of stenting using the Protégé® EverFlex™ and Protégé® GPS™ Self-Expanding Stent Systems for the treatment of atherosclerotic lesions in the common and/or external iliac arteries.
Interventions
DEVICEProtégé® EverFlex™ Self-Expanding Stent System, and Protégé® GPS™ Self-Expanding 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 nickel-titanium. * Life expectancy of less than 12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Adverse Event Rate | 9 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Protégé™ EverFlex™ and GPS™ Self-Expanding Stent Systems The objective of the study is to confirm the safety and effectiveness of the Protégé EverFlex and Protégé GPS Self-Expanding Stent Systems in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.
Protégé® EverFlex™ Self-Expanding Stent System, and Protégé® GPS™ Self-Expanding 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 | Lost to Follow-up | 2 |
| Overall Study | Missed visit | 2 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Protégé™ EverFlex™ and GPS™ Self-Expanding Stent Systems |
|---|---|
| Age, Continuous | 62.3 years STANDARD_DEVIATION 8.9 |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 44 / 75 |
| serious Total, serious adverse events | 29 / 75 |
Outcome results
Primary
Major Adverse Event Rate
Time frame: 9 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Protégé™ EverFlex™ and GPS™ Self-Expanding Stent Systems | Major Adverse Event Rate | 1.3 percentage of participants |