Peripheral Vascular Disease
Conditions
Brief summary
The purpose of this study is to evaluate the effectiveness and safety of a new delivery system for the Bard® LifeStent® Vascular Stent System.
Detailed description
Single-arm, non-randomized, prospective, multi-center study using the Bard® LifeStent® Vascular Stent Delivery System in subjects with lifestyle-limiting claudication or ischemic rest pain that are candidates for percutaneous transluminal angioplasty (PTA) and stenting with lesion(s) in the infra-inguinal segment (superficial femoral artery (SFA) and/or proximal popliteal artery). Subjects will be treated with PTA followed by implantation of the Bard® LifeStent® Vascular Stent. Clinical follow-up for all subjects will be performed prior to hospital discharge, 30-days, and 12-, 24-, and 36-months post-index procedure.
Interventions
DEVICEBard® LifeStent® Vascular Stent System
Stent Implantation
Sponsors
C. R. Bard
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The subject or legal representative has been informed of the nature of the evaluation, agrees to its provisions, and has signed the informed consent form (ICF). 2. Subject agrees to comply with the protocol-mandated follow-up procedures and visits. 3. The subject is ≥ 21 years old. 4. Female subjects of childbearing potential must have a negative urine or serum pregnancy test within seven days prior to index procedure. Female subjects who are surgically sterile or post-menopausal are exempt from having a pregnancy test. 5. The subject has lifestyle-limiting claudication or ischemic rest pain defined as: Rutherford Category1 2-4 (moderate claudication to ischemic rest pain). 6. The target lesion(s) has angiographic evidence of stenosis or restenosis ≥50% or occlusion (by visual estimate) and is amenable to PTA and stenting. 7. The total treated segment(s) must be ≤ 240 mm. 8. The target vessel reference diameter is ≥4.0 mm and ≤6.5 mm (by visual estimate) and therefore appropriate for treatment with available stent diameters of 6.0 mm and 7.0 mm. 9. There is angiographic evidence of at least one vessel runoff to the foot (at the level of the malleolus).
Exclusion criteria
1. The subject is unable or unwilling to provide informed consent or is unable or unwilling to comply with the study follow-up procedure and visits. 2. The subject has claudication or critical limb ischemia described as Rutherford Category1 1 (mild claudication), 5 (minor tissue loss) or 6 (major tissue loss). 3. The subject has a known contraindication (including allergic reaction) or sensitivity to antiplatelet/anticoagulant medications, nickel, titanium or tantalum. 4. The subject has a known sensitivity to contrast media that is not amenable to pretreatment with steroids or/and antihistamines. 5. The subject has a history of bleeding diatheses or coagulopathy. 6. The subject has concomitant renal failure with a creatinine of \>2.5 mg/dL. 7. The subject has concomitant hepatic insufficiency, thrombophlebitis, uremia, systemic lupus erythematosus (SLE), or deep vein thrombosis (DVT) at the time of the study procedure. 8. The subject is receiving dialysis or immunosuppressive therapy. 9. The subject is participating in an investigational drug or another investigational device study. 10. The subject has another medical condition, which, in the opinion of the investigator, may cause him/her to be non-compliant with the protocol, confound the data interpretation, or is associated with limited life expectancy of less than two years. 11. The subject has extensive peripheral vascular disease, which, in the opinion of the investigator, precludes safe insertion of an introducer sheath. 12. The target lesion(s) is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion(s). 13. The subject has angiographic evidence of poor inflow, which would be deemed inadequate to support a vascular bypass graft. 14. The subject is diagnosed with septicemia at the time of the study procedure. 15. Patients with a stent previously implanted into the target vessel. 16. Bilateral disease in the native SFA and/or proximal popliteal artery where both limbs meet the inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute Effectiveness: Percentage of Stents With Successful Delivery | At implantation (Day 0) | Effectiveness: Acute effectiveness defined as the successful delivery of the stent with the post-deployment stent length being within 10% of the pre-deployment length. |
| (Safety) Freedom From Occurrence of Death, Amputation and TVR/TLR at 30-days Post-index Procedure. | 30 day follow-up | Safety: Freedom from occurrence of death, amputation and TVR/TLR at 30-days post-index procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Primary Target Lesion Patency | 12 months post-index procedure | Percentage of participants with Primary Target Lesion Patency (TLP) at 12 months post-index procedure |
Countries
Austria, Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single-Arm The study population is comprised of subjects who present with lifestyle-limiting claudication or ischemic rest pain that are candidates for PTA and stenting. | 76 |
| Total | 76 |
Baseline characteristics
| Characteristic | Single-Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 52 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants |
| Age, Continuous | 70.1 Years STANDARD_DEVIATION 8.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 76 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 76 Participants |
| Region of Enrollment Germany | 76 participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 8 / 76 |
| other Total, other adverse events | 70 / 76 |
| serious Total, serious adverse events | 49 / 76 |
Outcome results
Primary
Acute Effectiveness: Percentage of Stents With Successful Delivery
Effectiveness: Acute effectiveness defined as the successful delivery of the stent with the post-deployment stent length being within 10% of the pre-deployment length.
Time frame: At implantation (Day 0)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PTA and Study Stent | Acute Effectiveness: Percentage of Stents With Successful Delivery | 100 percentage of stents |
Primary
(Safety) Freedom From Occurrence of Death, Amputation and TVR/TLR at 30-days Post-index Procedure.
Safety: Freedom from occurrence of death, amputation and TVR/TLR at 30-days post-index procedure.
Time frame: 30 day follow-up
Population: Freedom from occurrence of death, amputation and TVR/TLR at 30-days post-index procedure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PTA and Study Stent | (Safety) Freedom From Occurrence of Death, Amputation and TVR/TLR at 30-days Post-index Procedure. | 75 percentage of freedom from events |
Secondary
Primary Target Lesion Patency
Percentage of participants with Primary Target Lesion Patency (TLP) at 12 months post-index procedure
Time frame: 12 months post-index procedure
Population: Primary Target Lesion Patency (TLP) at 12 months post-index procedure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PTA and Study Stent | Primary Target Lesion Patency | 81.5 percentage of participants |