Atherosclerosis of Native Arteries of the Extremities
Conditions
Keywords
atherosclerosis, SFA, PPA, lower extremities, stenting, paclitaxel
Brief summary
To determine whether the Boston Scientific nitinol drug-eluting stent shows acceptable performance at 9 months when treating Superficial Femoral (SFA) and/or Proximal Popliteal Artery (PPA) lesions.
Interventions
DEVICEThe Boston Scientific DES SFA Paclitaxel-Eluting Self-Expanding Stent System (DES SFA)
Drug-eluting SFA self-expanding stent
Sponsors
Boston Scientific Corporation
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
* Subjects age 18 and older * Subject (or Legal Guardian if applicable) has signed the consent form and is willing and able to provide consent before any study-specific tests or procedures are performed and agrees to attend all required follow-up visits * Chronic, symptomatic lower limb ischemia defined as Rutherford categories 2, 3 or 4 * Stenotic, restenotic (from angioplasty only, previous treatment with drug coated balloon is not allowed) or occlusive lesion(s) located in the native superficial femoral artery or proximal popliteal artery: 1. Degree of stenosis ≥70% by visual angiographic assessment 2. Vessel diameter ≥ 4 and ≤ 6mm 3. Total lesion length (or series of lesions) ≥30 mm and ≤110 mm * (Note: tandem lesions may be treated, provided that the tandem lesion segment can be covered with only one stent) 4. Target lesion located at least three centimeters above the inferior edge of the femur * Patent infrapopliteal and popliteal artery, i.e., single vessel runoff or better with at least one of three vessels patent (\<50% stenosis) to the ankle or foot
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Patency | 9-months | Primary patency of target lesion at 9-months assessed by duplex ultrasound (DUS) as adjudicated by an independent core laboratory. Primary Patency: percentage (%) of lesions (target stented segments) that reach endpoint without a hemodynamically significant stenosis on DUS and without target lesion revascularization (TLR) or, bypass of the target lesion. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Composite of Major Adverse Events | 9 months | The composite rate of Major Adverse Events (MAEs) is defined as all causes of death through 1 month, target limb major amputation through 9 months and/or target lesion revascularization through 9 months. |
Countries
Australia, Austria, Belgium, Germany, New Zealand
Participant flow
Recruitment details
There were 57 subjects enrolled at 14 investigative centers in Europe, Australia and New Zealand. The first subject was enrolled on 23 August 2013. Enrollment was completed on 03 March 2014, when the last subject was enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Test Device Arm (DES SFA, ELUVIA™) All patients in this arm were treated with the study device.
The Boston Scientific DES SFA Paclitaxel-Eluting Self-Expanding Stent System (DES SFA, ELUVIA™) | 57 |
| Total | 57 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Test Device Arm (DES SFA, ELUVIA™) |
|---|---|
| Age, Continuous | 69.3 years STANDARD_DEVIATION 9.3 |
| General Medical History Current Diabetes Mellitus | 20 Participants |
| General Medical History History of Cerebrovascular Accident (CVA) | 5 Participants |
| General Medical History History of Chronic Obstructive Pulmonary Disease | 6 Participants |
| General Medical History History of Claudication | 51 Participants |
| General Medical History History of Congestive Heart Failure (CHF) | 3 Participants |
| General Medical History History of Coronary Artery Bypass Graft (CABG) | 8 Participants |
| General Medical History History of Coronary Artery Disease (CAD) | 22 Participants |
| General Medical History History of Hyperlipidemia requiring medication | 36 Participants |
| General Medical History History of Hypertension requiring medication | 42 Participants |
| General Medical History History of Myocardial Infarction (MI) | 9 Participants |
| General Medical History History of Percutaneous Coronary Intervention(PCI) | 11 Participants |
| General Medical History History of Peripheral Endovascular Intervention | 14 Participants |
| General Medical History History of Peripheral Vascular Surgery | 3 Participants |
| General Medical History History of Renal Insufficiency | 5 Participants |
| General Medical History History of Renal Percutaneous Intervention | 1 Participants |
| General Medical History History of Smoking | 50 Participants |
| General Medical History History of Transient Ischemic Attacks (TIA) | 3 Participants |
| General Medical History Stable Angina | 6 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 54 Participants |
| Race/Ethnicity, Customized Other | 2 Participants |
| Region of Enrollment Australia | 4 participants |
| Region of Enrollment Austria | 3 participants |
| Region of Enrollment Belgium | 19 participants |
| Region of Enrollment Germany | 21 participants |
| Region of Enrollment New Zealand | 10 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 57 |
| other Total, other adverse events | 36 / 57 |
| serious Total, serious adverse events | 34 / 57 |
Outcome results
Primary
Primary Patency
Primary patency of target lesion at 9-months assessed by duplex ultrasound (DUS) as adjudicated by an independent core laboratory. Primary Patency: percentage (%) of lesions (target stented segments) that reach endpoint without a hemodynamically significant stenosis on DUS and without target lesion revascularization (TLR) or, bypass of the target lesion.
Time frame: 9-months
Population: 54 subjects were included in this analysis - one 9 month visit was completed too early, outside the protocol defined visit window, one subject withdrew consent at the 1 month follow-up visit and one subject did not complete the 9 month follow up visit due to site relocation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test Device Arm (DES SFA, ELUVIA™) | Primary Patency | 94.4 percentage of lesions |
Other Pre-specified
Percentage of Participants With Composite of Major Adverse Events
The composite rate of Major Adverse Events (MAEs) is defined as all causes of death through 1 month, target limb major amputation through 9 months and/or target lesion revascularization through 9 months.
Time frame: 9 months
Population: 55 subjects were included in this analysis - one subject withdrew consent at the 1 month follow-up visit and one subject did not complete the 9 month follow up visit due to site relocation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Test Device Arm (DES SFA, ELUVIA™) | Percentage of Participants With Composite of Major Adverse Events | 9-Month MAE (Composite Endpoint) | 3.6 percentage of participants |
| Test Device Arm (DES SFA, ELUVIA™) | Percentage of Participants With Composite of Major Adverse Events | All Causes of Death at 1 month | 0.0 percentage of participants |
| Test Device Arm (DES SFA, ELUVIA™) | Percentage of Participants With Composite of Major Adverse Events | Target Limb Major Amputation | 0.0 percentage of participants |
| Test Device Arm (DES SFA, ELUVIA™) | Percentage of Participants With Composite of Major Adverse Events | Target Lesion Revascularization (TLR) | 3.6 percentage of participants |