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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
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)
Secondary ID [1] 0 0
BPV-12-001
Universal Trial Number (UTN)
Trial acronym
BOLSTER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Artery Disease 0 0
Peripheral Vascular Disease 0 0
Arterial Occlusive Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Surgery
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
9 months post index procedure
Secondary outcome [1] 0 0
Number of Participants With Major Adverse Events (MAEs) Through 9-Months Post Index Procedure.
Timepoint [1] 0 0
9 months post index procedure
Secondary outcome [2] 0 0
Number of Lesions With Acute Lesion Success
Timepoint [2] 0 0
At time of Index Procedure
Secondary outcome [3] 0 0
Number of Participants With Acute Procedure Success
Timepoint [3] 0 0
At time of hospital discharge
Secondary outcome [4] 0 0
Number of Devices With Acute Technical Success at Index Procedure
Timepoint [4] 0 0
At time of index procedure
Secondary outcome [5] 0 0
Number of Participants With Target Lesion Revascularization (TLR) at 6, 9, 12, 24, and 36 Months Post Index Procedure
Timepoint [5] 0 0
6, 9, 12, 24, and 36 months post index procedure
Secondary outcome [6] 0 0
Number of Participants With Target Vessel Revascularization (TVR) Event at 6, 9, 12, 24, and 36 Months Post Index Procedure.
Timepoint [6] 0 0
6, 9, 12, 24, and 36 months post index procedure
Secondary outcome [7] 0 0
Number of Participants With Sustained Clinical Success at 30-Days and 9, 12, 24, and 36 Months Post Index Procedure
Timepoint [7] 0 0
30 days, and 9, 12, 24, and 36 months post index procedure
Secondary outcome [8] 0 0
Number of Participants With Primary Patency at 9, 12, 24, and 36 Months Post Index Procedure
Timepoint [8] 0 0
9, 12, 24 and 36 months post index procedure
Secondary outcome [9] 0 0
Number of Participants With Assisted Primary Patency at 9, 12, 24, and 36 Months Post Index Procedure
Timepoint [9] 0 0
9, 12, 24, and 36 months post index procedure
Secondary outcome [10] 0 0
Number of Participants With Secondary Patency at 9, 12, 24, and 36 Months Post Index Procedure.
Timepoint [10] 0 0
9,12, 24, and 36 months post index procedure
Secondary outcome [11] 0 0
Change in Walking Impairment Questionnaire (WIQ) Scores at 30 Days, 9, 12, 24, and 36-Months Post Index Procedure Compared to Baseline.
Timepoint [11] 0 0
30 Days, 9, 12, 24, and 36 months post index procedure compared to baseline.

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.
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2018
Sample size
Target
Accrual to date
Final
155
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Washington
Country [10] 0 0
Germany
State/province [10] 0 0
Bad Krozingen
Country [11] 0 0
Germany
State/province [11] 0 0
Berlin
Country [12] 0 0
Germany
State/province [12] 0 0
Kaiserslautern
Country [13] 0 0
Germany
State/province [13] 0 0
Leipzig
Country [14] 0 0
Germany
State/province [14] 0 0
Lingen
Country [15] 0 0
New Zealand
State/province [15] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
C. R. Bard
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT02228564
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
John R Laird, M.D.
Address 0 0
U. C. Davis Medical Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02228564