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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02228564
Registration number
NCT02228564
Ethics application status
Date submitted
15/08/2014
Date registered
29/08/2014
Date last updated
8/10/2020
Titles & IDs
Public title
BARD® Study of LIFESTREAM™ Balloon Expandable Covered Stent Treating Iliac Arterial Occlusive Disease
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Scientific 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)
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Secondary ID [1]
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BPV-12-001
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Universal Trial Number (UTN)
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Trial acronym
BOLSTER
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Peripheral Artery Disease
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Peripheral Vascular Disease
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Arterial Occlusive Disease
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Surgery - Percutaneous transluminal angioplasty (PTA)
Treatment: Devices - LIFESTREAM™ covered stent
Experimental: LIFESTREAM™ - This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent.
Treatment: Surgery: Percutaneous transluminal angioplasty (PTA)
Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
Treatment: Devices: LIFESTREAM™ covered stent
Implantation of the LIFESTREAM™ covered stent
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Intervention code [1]
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Treatment: Surgery
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Intervention code [2]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
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The primary endpoint is a composite safety and effectiveness measure defined as 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.
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Timepoint [1]
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9 months post index procedure
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Secondary outcome [1]
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Number of Participants With Major Adverse Events (MAEs) Through 9-Months Post Index Procedure.
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Assessment method [1]
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Major Adverse Events (MAE) defined as device and/or procedure-related death or MI through 30 days, or any TLR or target limb(s) major amputation through 9-months post-index procedure. Major amputation is defined as an amputation at or above the ankle.
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Timepoint [1]
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9 months post index procedure
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Secondary outcome [2]
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Number of Lesions With Acute Lesion Success
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Assessment method [2]
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Acute Lesion Success defined as attainment of \< 30% residual stenosis of the target lesion after the index procedure using any percutaneous method and/or non-investigational device (i.e., post-dilatation), as determined by an Independent Angiographic Core Lab.
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Timepoint [2]
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At time of Index Procedure
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Secondary outcome [3]
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Number of Participants With Acute Procedure Success
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Assessment method [3]
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Acute Procedure Success defined as lesion success and no peri-procedural complications (death, stroke, myocardial infarction (MI), emergent surgical revascularization, significant distal embolization in target limb, and thrombosis of target vessel) prior to hospital discharge.
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Timepoint [3]
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At time of hospital discharge
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Secondary outcome [4]
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Number of Devices With Acute Technical Success at Index Procedure
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Assessment method [4]
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Acute Technical Success defined as successful deployment of the LIFESTREAM™ Covered Stent at the intended location, as determined by the Investigator.
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Timepoint [4]
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At time of index procedure
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Secondary outcome [5]
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Number of Participants With Target Lesion Revascularization (TLR) at 6, 9, 12, 24, and 36 Months Post Index Procedure
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Assessment method [5]
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Target Lesion Revascularization (TLR) is defined as the first revascularization procedure (e.g., PTA, atherectomy, etc.) of the target lesion(s) following the index procedure, as determined by an Independent Angiographic Core Lab. All Target Lesion Revascularizations (TLR) were Target Vessel Revascularizations (TVR) and therefore, the results presented in Outcome #6 and Outcome #7 are the same.
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Timepoint [5]
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6, 9, 12, 24, and 36 months post index procedure
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Secondary outcome [6]
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Number of Participants With Target Vessel Revascularization (TVR) Event at 6, 9, 12, 24, and 36 Months Post Index Procedure.
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Assessment method [6]
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Target Vessel Revascularization (TVR) is defined as the first revascularization procedure (e.g. PTA, stenting, surgical bypass, etc.) in the target vessel(s) following the index procedure, as determined by an Independent Angiographic Core Lab. All Target Vessel Revascularizations (TVR) were Target Lesion Revascularizations (TLR) and therefore, the results presented in Outcome #6 and Outcome #7 are the same.
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Timepoint [6]
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6, 9, 12, 24, and 36 months post index procedure
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Secondary outcome [7]
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Number of Participants With Sustained Clinical Success at 30-Days and 9, 12, 24, and 36 Months Post Index Procedure
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Assessment method [7]
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Sustained Clinical Success defined as sustained cumulative improvement from baseline value of = 1 Rutherford Category23 at 30-days and 9, 12, 24, and 36-months post-index procedure, as determined by the Investigator.
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Timepoint [7]
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30 days, and 9, 12, 24, and 36 months post index procedure
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Secondary outcome [8]
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Number of Participants With Primary Patency at 9, 12, 24, and 36 Months Post Index Procedure
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Assessment method [8]
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Primary Patency at 9, 12, 24 and 36-months post-index procedure corresponding to PSVR = 2.4.
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Timepoint [8]
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9, 12, 24 and 36 months post index procedure
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Secondary outcome [9]
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Number of Participants With Assisted Primary Patency at 9, 12, 24, and 36 Months Post Index Procedure
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Assessment method [9]
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Primary Assisted Patency at 9-, 12-, 24-, and 36-months post-index procedure corresponding to PSVR = 2.4, as determined by an Independent DUS Core Lab. Primary Assisted Patency is independent of whether or not patency is re-established via an endovascular procedure following restenosis.
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Timepoint [9]
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9, 12, 24, and 36 months post index procedure
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Secondary outcome [10]
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Number of Participants With Secondary Patency at 9, 12, 24, and 36 Months Post Index Procedure.
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Assessment method [10]
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Secondary Patency is a measure of success at re-establishing patency following failure of the initial stent placement due to stenosis or re-occlusion. In this study, Secondary Patency was independent of whether or not patency was re-established via an endovascular procedure following restenosis or occlusion, and was analyzed for the Intent to Treat (ITT) population. Secondary patency is defined as a peak systolic velocity ratio (PSVR) = 2.4, as determined by an independent Duplex Ultrasonography (DUS) Core Lab.
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Timepoint [10]
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9,12, 24, and 36 months post index procedure
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Secondary outcome [11]
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Change in Walking Impairment Questionnaire (WIQ) Scores at 30 Days, 9, 12, 24, and 36-Months Post Index Procedure Compared to Baseline.
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Assessment method [11]
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The WIQ assesses 3 categories of activities that include 1) walking distance, 2) stair-climbing, and 3) walking speed. Each question requires participants to rate their degree of difficulty with the activity on a scale of 0 (unable) to 4 (no problem). Final scores range from 0% to 100%, with lower percentages indicating higher levels of difficulties with activities.The results below represent the mean differences in total Walking Impairment Questionnaire (WIQ) scores at 30 days,9, 12, 24, and 36 months compared to baseline assessment scores.
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Timepoint [11]
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30 Days, 9, 12, 24, and 36 months post index procedure compared to baseline.
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Eligibility
Key inclusion 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.
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Minimum age
21
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2018
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Sample size
Target
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Accrual to date
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Final
155
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
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United States of America
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Arkansas
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United States of America
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California
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United States of America
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Florida
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United States of America
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Massachusetts
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United States of America
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Missouri
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North Carolina
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Pennsylvania
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Texas
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Washington
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Germany
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Bad Krozingen
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Germany
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Berlin
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Germany
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Kaiserslautern
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Germany
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Leipzig
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Germany
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Lingen
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New Zealand
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State/province [15]
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Auckland
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
C. R. Bard
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Address
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT02228564
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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John R Laird, M.D.
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Address
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U. C. Davis Medical Center
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Fax
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Email
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Contact person for public queries
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/64/NCT02228564/Prot_SAP_000.pdf
Statistical analysis plan
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/64/NCT02228564/Prot_SAP_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02228564
Download to PDF