DRKS00010189已完成未知
A prospective, multi-center, randomized, concurrently-controlled clinical study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft in the treatment of stenosis in the venous outflow of AV fistula access circuits (AVeNEW) - AVeNEW
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 280
研究概览
简要总结
The AVeNEW study results provide scientific evidence that the COVERA™Vascular Covered Stent and Delivery System is safe and effective for the treatment of stenotic lesions in the venous outflow of hemodialysis subjects dialyzing with an AV fistula.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 21 Years 至 one（—）
- 性别
- All
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 clinical and telephone follow-up.
- •4. Subject must have an upper extremity AV fistula that has undergone at least one successful dialysis session with two-needle cannulation, 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 = 9 cm 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 9.0 mm.
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 hypersensitivity to contrast media which cannot be adequately pre-medicated.
- •7. The subject has a known hypersensitivity to nickel-titanium (Nitinol) or tantalum.
- •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. An aneurysm or pseudoaneurysm is present within the target lesion.
- •12. The location of the target lesion would require the COVERA™ 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 COVERA™ 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 COVERA™ Vascular Covered Stent be placed in the central veins (subclavian, brachiocephalic, Superior Vena Cava (SVC)) or under the clavicle at the thoracic outlet.
- •16. There is incomplete expansion of an appropriately sized angioplasty balloon to its expected profile, in the operator’s judgment, during primary angioplasty at the target lesion prior to randomization.
研究者
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