A Prospective, Multi-Center, Non-Randomized, Single-Arm Study of the BARD® LIFESTREAM™ Balloon Expandable Vascular Covered Stent in the Treatment of Iliac Artery Occlusive Disease (BOLSTER)
- Conditions
- I70.2Atherosclerosis of arteries of extremities
- Registration Number
- DRKS00006828
- Lead Sponsor
- Bard Peripheral Vascular, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 154
1. The subject provides written informed consent using an Informed
Consent Form (ICF) that is reviewed and approved by the Ethics
Committee (EC) / Institutional Review Board (IRB) for the site.
2. Subject agrees to comply with the protocol-mandated follow-up
procedures and visits.
3. The subject is a male or non-pregnant female = 21 years old with an
expected lifespan sufficient to allow for completion of all study
procedures. Female subjects of childbearing potential must have a
negative pregnancy test (urine or blood) within 14 days prior to the index
procedure.
4. The subject has intermittent claudication (Rutherford Category 2-3) or
ischemic rest pain (Rutherford Category 4).
5. The subject is able and willing to comply with any required medication
regimen.
6. The subject has evidence of single, bilateral, or multiple de novo and/or
restenotic (non-stented) lesion(s) in the native common and/or external
iliac artery that is (are) = 50% stenosed
7. The target lesion(s) can be successfully crossed with a guide wire and
pre-dilated with an appropriately sized PTA balloon. Devices such as
chronic total occlusion (CTO) catheters or re-entry devices may be used
to facilitate target lesion(s) crossing.
8. The reference vessel diameter(s) is (are) between 4.5 mm and 12.0 mm
in diameter as determined by the Investigator’s visual estimate.
9. The target lesion(s) is (are) = 100 mm in combined length (per side) as
determined by the Investigator’s visual estimate.
10. The subject has angiographic evidence of a patent (< 50% stenosis)
profunda and/or superficial femoral artery (SFA) in the target limb(s) as
determined by the Investigator’s visual estimate. Ipsilateral and
contralateral SFA lesions may be treated before or after target lesion
treatment, considering the following criteria are met:
- = 50% stenosis
- Stenosis(es) = 15cm in total length or a Total Occlusion = 5cm in
length
- = 1 vessel run-off
- No thrombus or severe calcification
- Use of on-Label devices
1. The subject is unable or unwilling to provide written informed consent,
or is unable or unwilling to conform to the study protocol follow-up
procedures and visits.
2. The subject is or plans to become pregnant during the study.
3. The subject is asymptomatic, has mild claudication or critical limb
ischemia with tissue loss described as Rutherford Category 0
(asymptomatic), 1 (mild claudication), 5 (minor tissue loss), or 6 (major
tissue loss).
4. The subject has a vascular graft previously implanted in the native iliac
vessel.
5. The subject suffered a hemorrhagic stroke or transient ischemic attack
(TIA) within 3 months prior to the index procedure.
6. The subject has a known uncorrectable bleeding diathesis or active
coagulopathy (platelet count < 80,000/µL).
7. The subject has a serum creatinine = 2.5 mg/dl or is currently on dialysis.
8. The subject has a known allergy or sensitivity to stainless steel (i.e.,
Nickel), ePTFE, or has intolerance to the antiplatelet, anticoagulant or
thrombolytic medications required per the protocol.
9. The subject has a known allergy or sensitivity to contrast media, which
cannot be adequately pre-medicated.
10. The subject had a prior vascular intervention(s) within 30 days before,
or has an intervention planned for within 30 days after the index
procedure. Refer to inclusion criterion #10 for exceptions on ipsilateral
SFA lesions and contralateral iliac and SFA lesions.
11. 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 a life expectancy
insufficient to allow for the completion of study procedures and followup.
12. The subject is currently participating in an investigational drug,
biologic, or another device study.
13. The subject has extensive peripheral vascular disease, which in the
opinion of the Investigator, would preclude safe insertion of an introducer sheath (>50% Stenosis of common femoral artery)
14. The target lesion(s) requires treatment other than angioplasty (e.g.,
atherectomy, cryoplasty, cutting/scoring balloons, etc.) to facilitate
subject device delivery. Devices such as CTO catheters or re-entry
devices may be used to facilitate target lesion(s) crossing.
15. The subject has severe calcification of the target lesion(s), which
prevents inflation of a PTA balloon (pre-dilatation of the target lesion is
required).
16. The target lesion(s) has been previously treated with a stent (bare or
covered). A target vessel(s) with a previously placed stent is permitted as
long as the subject device(s) will not come into contact with the
previously placed stent during treatment of the target lesion(s).
17. The subject has angiographic evidence of acute thrombus at the target
lesion(s).
18. The target lesion(s) involves the origin of the internal iliac artery such
that successful treatment of the lesion(s) would require the subject
device(s) to cross/occlude the side branch. Note, if the internal iliac
artery is already occluded, the subject device(s) can be placed across the
occluded vessel.
19. The target lesion(s) is (are) located in the distal external iliac artery
such that successful treatment of the lesion(s) would require the subject
device(s) to cross/occlude side branches (inferior epigastric artery and/or
deep circumflex iliac artery) 20. The subject has an abdominal aortic an
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Composite safety and effectiveness measure defined as device and/or<br>procedure-related death or myocardial infarction (MI) through 30 days, or<br>any TLR, target limb(s) major amputation, or restenosis (as determined by<br>Duplex Ultrasonography) through 9-months post-index procedure
- Secondary Outcome Measures
Name Time Method Target Lesion Revascularization (at 6, 9, 12, 24, 36 months post-index procedure);<br>Target Vessel Revascularization (at 6, 9, 12, 24, 36 months post-index procedure);<br>Primary Patency determined as Peak Systolic Velocity Ratio (PSVR) of <2.4 (at 9, 12, 24, 36 months post-index procedure) determined by DUS;<br>Secondary Patency determined as PSVR of <2.4 (at 9, 12, 24, 36 months post-index procedure) determined by DUS;<br>Walking Impairment (at baseline, 30 days, 9, 12, 24 and 36 month post-index procedure) assessed by a questionnaire.<br><br><br><br><br>