DRKS00006828
Completed
未知
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) - BOLSTER
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- I70.2
- Sponsor
- Bard Peripheral Vascular, Inc.
- Enrollment
- 154
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •4\. The subject has intermittent claudication (Rutherford Category 2\-3\) or
Exclusion Criteria
- •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
- •5\. The subject suffered a hemorrhagic stroke or transient ischemic attack
Outcomes
Primary Outcomes
Not specified
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