Clinical trial NCT02228564: BARD® Study of LIFESTREAM™ Balloon Expandable Covered Stent Treating Iliac Arterial Occlusive Disease
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Artery Disease
Peripheral Vascular Disease
Arterial Occlusive Disease
Keywords: Lack of perfusion in the extremities
Atherosclerosis
Intermittent claudication
BOLSTER
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2014-08-29
Enrollment: 155
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Collect confirmatory evidence of the safety and effectiveness of the Balloon LIFESTREAM™ Stent Graft for the treatment of stenoses and occlusion in the iliac arteries.


Eligibility criteria: CLINICAL INCLUSION CRITERIA:

* The subject provides written informed consent using an Informed Consent Form approved by the Ethics Committee/ Institutional Review Board for the site.
* Subject agrees to comply with the protocol-mandated follow-up procedures and visits.
* Subject is a male or non-pregnant female ≥ 21 years old with an expected lifespan sufficient to allow for completion of all study procedures.
* Subject has intermittent claudication (Rutherford Category 2-3) or ischemic rest pain (Rutherford Category 4).
* Subject is able and willing to comply with any required medication regimen.

ANGIOGRAPHIC INCLUSION CRITERIA:

* Subject has evidence of single, bilateral, or multiple de novo and/or restenotic (non-stented) lesion in the native common and/or external iliac artery that is ≥ 50% stenosed (including total occlusions).
* The target lesion can be successfully crossed with a guide wire and pre-dilated with an appropriately sized PTA balloon.
* The reference vessel diameter is between 4.5 mm -12.0 mm in diameter.
* The target lesion is ≤ 100 mm in combined length (per side).
* The subject has angiographic evidence of a patent (\< 50% stenosis) profunda and/or superficial femoral artery (SFA) in the target limb.

CLINICAL EXCLUSION CRITERIA:

* The subject is unable or unwilling to provide written informed consent or to conform to the study protocol follow-up procedures and visits.
* The subject is or plans to become pregnant during the study.
* The subject is asymptomatic, has mild claudication or critical limb ischemia with tissue loss described as Rutherford Category 0, 1, 5 or 6.
* The subject has a vascular graft previously implanted in the native iliac vessel.
* The subject suffered a hemorrhagic stroke or transient ischemic attack (TIA) within 3 months prior to the index procedure.
* The subject has a known uncorrectable bleeding diathesis or active coagulopathy.
* The subject has a serum creatinine ≥ 2.5 mg/dl or is on dialysis.
* 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.
* The subject has a known allergy or sensitivity to contrast media, which cannot be adequately pre-medicated.
* The subject had a prior vascular intervention within 30 days before or planned for within 30 days after the index procedure.
* The subject has another medical condition, which 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 follow-up.
* The subject is currently participating in an investigational drug, biologic, or another device study.

ANGIOGRAPHIC EXCLUSION CRITERIA:

* The subject has extensive peripheral vascular disease, which in the opinion of the Investigator, would preclude safe insertion of an introducer sheath. The ipsilateral common femoral artery should be patent (\< 50% stenosis).
* The target lesion requires treatment other than angioplasty to facilitate subject device delivery.
* The subject has severe calcification of the target lesion, preventing inflation of PTA balloon.
* The target lesion has been previously treated with a stent (bare or covered).
* The subject has angiographic evidence of acute thrombus at the target lesion.
* The target lesion involves the origin of the internal iliac artery such that successful treatment of the lesion would require the subject device to cross/occlude the side branch.
* The target lesion located in the distal external iliac artery such that successful treatment of the lesion would require the subject device to cross/occlude side branches or be exposed to compressive forces associated with the close proximity to the common femoral artery.
* The subject has an abdominal aortic aneurysm (AAA) contiguous to the iliac artery target lesion.
* The subject has a pre-existing target iliac artery aneurysm or perforation or dissection of the target iliac artery prior to the initiation of the treatment for this study.

Primary outcomes:
measure: Number of Participants With Device and/or Procedure-Related Death or Myocardial Infarction (MI) Through 30 Days, or Any Target Lesion Revascularization (TLR), Target Limb(s) Major Amputation, or Restenosis Through 9-Months Post Index Procedure.
timeFrame: 9 months post index procedure
Secondary outcomes:
measure: Number of Participants With Major Adverse Events (MAEs) Through 9-Months Post Index Procedure.
timeFrame: 9 months post index procedure
measure: Number of Lesions With Acute Lesion Success
timeFrame: At time of Index Procedure
measure: Number of Participants With Acute Procedure Success
timeFrame: At time of hospital discharge
measure: Number of Devices With Acute Technical Success at Index Procedure
timeFrame: At time of index procedure
measure: Number of Participants With Target Lesion Revascularization (TLR) at 6, 9, 12, 24, and 36 Months Post Index Procedure
timeFrame: 6, 9, 12, 24, and 36 months post index procedure
measure: Number of Participants With Target Vessel Revascularization (TVR) Event at 6, 9, 12, 24, and 36 Months Post Index Procedure.
timeFrame: 6, 9, 12, 24, and 36 months post index procedure
measure: Number of Participants With Sustained Clinical Success at 30-Days and 9, 12, 24, and 36 Months Post Index Procedure
timeFrame: 30 days, and 9, 12, 24, and 36 months post index procedure
measure: Number of Participants With Primary Patency at 9, 12, 24, and 36 Months Post Index Procedure
timeFrame: 9, 12, 24 and 36 months post index procedure
measure: Number of Participants With Assisted Primary Patency at 9, 12, 24, and 36 Months Post Index Procedure
timeFrame: 9, 12, 24, and 36 months post index procedure
measure: Number of Participants With Secondary Patency at 9, 12, 24, and 36 Months Post Index Procedure.
timeFrame: 9,12, 24, and 36 months post index procedure
measure: Change in Walking Impairment Questionnaire (WIQ) Scores at 30 Days, 9, 12, 24, and 36-Months Post Index Procedure Compared to Baseline.
timeFrame: 30 Days, 9, 12, 24, and 36 months post index procedure compared to baseline.
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Heart Hospital
state: Arkansas
city: Orange
country: United States
facility: Vascular and Interventional Specialists of Orange County
state: California
city: Sacramento
country: United States
facility: UC Davis Cardiovascular Medicine
state: California
city: Gainesville
country: United States
facility: Florida Research Network
state: Florida
city: Jacksonville
country: United States
facility: Baptist Medical Center
state: Florida
city: Lakeland
country: United States
facility: Lakeland Regional Medical Center
state: Florida
city: Miami
country: United States
facility: Mount Sinai Medical Center
state: Florida
city: Worcester
country: United States
facility: University of Massachusetts Worcester
state: Massachusetts
city: Kansas City
country: United States
facility: Kansas City Vascular Foundation
state: Missouri
city: Gastonia
country: United States
facility: CaroMont Regional Medical Center
state: North Carolina
city: Raleigh
country: United States
facility: North Carolina Heart and Vascular
state: North Carolina
city: Sayre
country: United States
facility: Donald Guthrie Foundation
state: Pennsylvania
city: Galveston
country: United States
facility: Univeristy of Texas Medical Branch
state: Texas
city: Seattle
country: United States
facility: Swedish Health Services
state: Washington
city: Bad Krozingen
country: Germany
facility: Universitäts-Herzzentrum Freiburg-Bad Krozingen GmbH
city: Berlin
country: Germany
facility: Ev.Krankenhaus Königin Elisabeth
city: Kaiserslautern
country: Germany
facility: Praxis fur Interventionelle Angiologie
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig
city: Lingen
country: Germany
facility: Bonifatius Hospital
city: Auckland
country: New Zealand
facility: Auckland Hospital
Study officials:
affiliation: U. C. Davis Medical Center
name: John R Laird, M.D.
role: PRINCIPAL_INVESTIGATOR
References: