An interventional study of The Boston Scientific DES SFA Paclitaxel-Eluting Self-Expanding Stent System (DES SFA) in Atherosclerosis of Native Arteries of the Extremities, sponsored by Boston Scientific Corporation. Completed at 13 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-22.
Sponsored by Boston Scientific Corporation · Not applicable, Interventional, and Treatment
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.
1,567 studies on the registry are indexed under Atherosclerosis; 264 are open to participants now.
This study's enrollment of 57 is below the median of 106 across 882 interventional studies indexed under Atherosclerosis.
Browse Atherosclerosis studies →Boston Scientific Corporation is the lead sponsor of 517 studies on the registry; 38 are open to participants now.
Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.
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Inclusion Criteria:
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:
Total lesion length (or series of lesions) ≥30 mm and ≤110 mm
Patients in this arm will receive the study device: the Boston Scientific DES SFA Paclitaxel-Eluting Self-Expanding Stent System (DES SFA)
Device: The Boston Scientific DES SFA Paclitaxel-Eluting Self-Expanding Stent System (DES SFA)
Drug-eluting SFA self-expanding stent
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
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
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.
| Milestone | Test Device Arm (DES SFA, ELUVIA™) |
|---|---|
| Started | 57 |
| Completed | 54 |
| Not completed | 3 |
| Withdrew: Death | 2 |
| Withdrew: Withdrawal by subject | 1 |
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.
| percentage of lesions | Test Device Arm (DES SFA, ELUVIA™) |
|---|---|
| Primary Patency | 94.4 (86.3 to 98.5) |
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.
| percentage of participants | Test Device Arm (DES SFA, ELUVIA™) |
|---|---|
| 9-Month MAE (Composite Endpoint) | 3.6 (0.4 to 12.5) |
| All Causes of Death at 1 month | 0.0 (0.0 to 6.5) |
| Target Limb Major Amputation | 0.0 (0.0 to 6.5) |
| Target Lesion Revascularization (TLR) | 3.6 (0.4 to 12.5) |
Collected over 3 years +/- 30 days visit window from the date of the index procedure.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Test Device Arm (DES SFA, ELUVIA™) | 2/57 (3.5%) | 34/57 (59.6%) | 36/57 (63.2%) |
| Event | Test Device Arm (DES SFA, ELUVIA™) |
|---|---|
| Femoral artery stenosisVascular disorders | 14/57 |
| Peripheral arterial occlusive diseaseVascular disorders | 4/57 |
| Arterial thrombosis limbVascular disorders | 3/57 |
| Arterial stenosis limbVascular disorders | 3/57 |
| Femoral artery occlusionVascular disorders | 2/57 |
| Intermittent claudicationVascular disorders | 2/57 |
| Atrial fibrillationCardiac disorders | 2/57 |
| Carotid artery stenosisNervous system disorders | 2/57 |
| Peripheral ischaemiaVascular disorders | 1/57 |
| Arterial occlusive diseaseVascular disorders | 1/57 |
| Event | Test Device Arm (DES SFA, ELUVIA™) |
|---|---|
| Femoral arterial stenosisVascular disorders | 9/57 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 5/57 |
| Femoral artery occlusionVascular disorders | 3/57 |
| Musculoskeletal painMusculoskeletal and connective tissue disorders | 3/57 |
| Adverse drug reactionGeneral disorders | 3/57 |
| Catheter site haemorrhageGeneral disorders | 3/57 |
| Oedema peripheralGeneral disorders | 3/57 |
| Iliac artery stenosisVascular disorders | 2/57 |
| Catheter site haematomaGeneral disorders | 2/57 |
| Dry eyeEye disorders | 2/57 |
| Age, Continuous(years) | Test Device Arm (DES SFA, ELUVIA™) |
|---|---|
| Mean | 69.3 ± 9.3 |
| Sex: Female, Male(Participants) | Test Device Arm (DES SFA, ELUVIA™) |
|---|---|
| Female | 10 |
| Male | 47 |
| Race/Ethnicity, Customized(Participants) | Test Device Arm (DES SFA, ELUVIA™) |
|---|---|
| Caucasian | 54 |
| Asian | 1 |
| Other | 2 |
| Region of Enrollment(participants) | Test Device Arm (DES SFA, ELUVIA™) |
|---|---|
| New Zealand | 10 |
| Austria | 3 |
| Belgium | 19 |
| Australia | 4 |
| Germany | 21 |
| General Medical History(Participants) | Test Device Arm (DES SFA, ELUVIA™) |
|---|---|
| History of Smoking | 50 |
| Current Diabetes Mellitus | 20 |
| History of Hyperlipidemia requiring medication | 36 |
| History of Hypertension requiring medication | 42 |
| History of Chronic Obstructive Pulmonary Disease | 6 |
| History of Coronary Artery Disease (CAD) | 22 |
| History of Myocardial Infarction (MI) | 9 |
| History of Congestive Heart Failure (CHF) | 3 |
| History of Percutaneous Coronary Intervention(PCI) | 11 |
| History of Coronary Artery Bypass Graft (CABG) | 8 |
| Stable Angina | 6 |
| History of Transient Ischemic Attacks (TIA) | 3 |
| History of Cerebrovascular Accident (CVA) | 5 |
| History of Renal Insufficiency | 5 |
| History of Renal Percutaneous Intervention | 1 |
| History of Peripheral Vascular Surgery | 3 |
| History of Peripheral Endovascular Intervention | 14 |
| History of Claudication | 51 |
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