NL-OMON47014已完成不适用
A Prospective, Multi-Center, Randomized, Concurrently- Controlled Clinical Study of the BARD® COVERATM Arteriovenous (AV) Stent Graft in the Treatment of Stenosis in the Venous Outflow of AV Fistula Access Circuits (AVeNEW) - AVeNEW study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Clinical Inclusion Criteria
- •1. Subject must voluntarily sign and date the Informed Consent Form (ICF) prior to
- •collection of study data or performance of study procedures.
- •2. Subject must be either a male or non-pregnant female > 21 years of age with an
- •expected lifespan sufficient to allow for completion of all study procedures.
- •3. Subject must be willing to comply with the protocol requirements, including the
- •follow-up procedures, and be contacted by telephone.
- •4. Subject must have a mature AV fistula located in an arm, and must have
- •undergone at least one successful dialysis session prior to the index procedure.
- •Angiographic Inclusion Criteria
- •5. Subject must have angiographic evidence of a stenosis > 50% (by visual
- •estimation) located in the venous outflow of the AV access circuit and present
- •with clinical or hemodynamic evidence of AV fistula dysfunction.
- •6. The target lesion must be < 9cm in length. Note: multiple stenoses may exist
- •within the target lesion.
- •7. The reference vessel diameter of the adjacent non-stenotic vein must be between
- •5.0 and 9.0mm.
- •Exclusion Criteria
排除标准
- •Clinical Exclusion Criteria
- •1. The subject is dialyzing with an AV graft.
- •2. The target lesion has had a corresponding thrombosis treated within 7 days prior
- •to the index procedure.
- •3. The hemodialysis access is located in the lower extremity.
- •4. The subject has an infected AV fistula or uncontrolled systemic infection.
- •5. The subject has a known uncontrolled blood coagulation/bleeding disorder.
- •6. The subject has a known allergy or sensitivity to contrast media which cannot be
- •adequately pre-medicated.
- •7. The subject has a known hypersensitivity to nickel-titanium (Nitinol).
- •8. 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 follow-up.
- •9. The subject is currently participating in an investigational drug or another device
- •study that has not completed the study treatment or that clinically interferes with
- •the study endpoints. Note: Studies requiring extended follow-up visits for
- •products that were investigational, but have since become commercially
- •available, are not considered investigational studies.
- •Angiographic Exclusion Criteria
- •10. Additional stenotic lesions (> 50%) in the venous outflow that are > 3cm from the
- •edge of the target lesion and are not successfully treated (defined as < 30%
- •residual stenosis) prior to treating the target lesion.
- •11. A pseudoaneurysm is present within the target lesion.
- •12. The location of the target lesion would require the COVERATM Vascular Covered
- •Stent be deployed across the elbow joint.
- •13. The target lesion is located within a stent.
- •14. The location of the target lesion would require that the COVERATM Vascular
- •Covered Stent be deployed at or across the segment of fistula utilized for dialysis
- •needle puncture (i.e., cannulation zone).
- •15. The location of the target lesion would require that the COVERATM Vascular
- •Covered Stent be placed in the central veins (subclavian, brachiocephalic,
- •Superior Vena Cava (SVC)).
- •16. Full expansion of an appropriately sized angioplasty balloon, in the operator's
- •judgment, cannot be achieved during primary angioplasty at the target lesion
- •prior to randomization.
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