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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 280
- 试验地点
- 48
- 主要终点
- Effectiveness Endpoint: Number of Participants With Target Lesion Primary Patency (TLPP)
研究概览
简要总结
The objective of this study is to assess the safety and effectiveness of the COVERA™ Vascular Covered Stent for the treatment of stenotic lesions in the upper extremity venous outflow of the Arteriovenous (AV) access circuit.
详细描述
This study will compare the use of the COVERA™ Vascular Covered Stent (following percutaneous transluminal angioplasty (PTA)) to PTA alone for the treatment of stenotic lesions in the upper extremity venous outflow of the arteriovenous (AV) access circuit of subjects dialyzing with an AV fistula.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical Inclusion Criteria:
- •Subject must voluntarily sign and date the Informed Consent Form (ICF) prior to collection of study data or performance of study procedures.
- •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.
- •Subject must be willing to comply with the protocol requirements, including the clinical and telephone follow-up.
- •Subject must have an upper extremity arteriovenous (AV) fistula that has undergone at least one successful dialysis session with two-needle cannulation, prior to the index procedure.
- •Angiographic Inclusion Criteria:
- •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.
- •The target lesion must be ≤ 9cm in length. Note: multiple stenoses may exist within the target lesion.
- •The reference vessel diameter of the adjacent non-stenotic vein must be between 5.0 and 9.0mm.
排除标准
- •The subject is dialyzing with an AV graft.
- •The target lesion has had a corresponding thrombosis treated within 7 days prior to the index procedure.
- •The hemodialysis access is located in the lower extremity.
- •The subject has an infected AV fistula or uncontrolled systemic infection.
- •The subject has a known uncontrolled blood coagulation/bleeding disorder.
- •The subject has a known allergy or hypersensitivity to contrast media which cannot be adequately pre-medicated.
- •The subject has a known hypersensitivity to nickel-titanium (Nitinol) or tantalum.
- •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.
- •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:
- •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.
- •An aneurysm or pseudoaneurysm is present within the target lesion.
- •The location of the target lesion would require the COVERA™ Vascular Covered Stent be deployed across the elbow joint.
- •The target lesion is located within a stent.
- •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").
- •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.
- •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.
结局指标
主要结局
Effectiveness Endpoint: Number of Participants With Target Lesion Primary Patency (TLPP)
时间窗: 6 months post index procedure
TLPP is defined as the interval following the index intervention until the next clinically driven reintervention at, or adjacent to,the original treatment site or until the extremity is abandoned for permanent access. Primary patency ends when any of the following occurs: a) clinically driven reintervention in the treatment area; b) thrombotic occlusion within the treatment area; c) surgical intervention that excludes the original treatment area from the AV circuit, and/or d) abandonment of the AV fistula due to inability to treat the original treatment area. COVERA Vascular Covered Stent (following PTA) is evaluated against subjects treated PTA alone.
Number of Participants With Freedom From AV Access Circuit Localized or Systemic Serious Adverse Events
时间窗: 30 days post index procedure
Safety is defined as freedom from any adverse event(s) (AEs), localized or systemic, that reasonably suggests the involvement of the AV access circuit (not including stenosis or thrombosis) that require or result in any of the following alone or in combination: additional interventions (including surgery); in-patient hospitalization or prolongation of an existing hospitalization; or death.
次要结局
- Number of Participants With Access Circuit Primary Patency (ACPP)(1, 3, 12, 18, and 24 months post index procedure)
- Total Number of Arteriovenous (AV) Access Circuit Reinterventions(1, 3, 6, 12, 18 and 24 months post index procedure)
- Number of Participants With Access Circuit Primary Patency (ACPP).(6 months post index procedure)
- Index of Patency Function - Target Lesion (IPF-T)(1, 3, 6, 12, 18 and 24 months post index procedure)
- Number of Patients With Target Lesion Primary Patency (TLPP) at 12 Months Post Index Procedure(12 months post-index procedure)
- Number of Participants With Target Lesion Primary Patency (TLPP)(1, 3, 18 and 24 months post index procedure)
- Number of Participants Free From Device and Procedure Related AEs Involving the AV Access Circuit(Evaluation through 1, 3, 6, 12, 18, and 24 months post-index procedure)
- Index of Patency Function (IPF)(1, 3, 6, 12, 18 and 24 months post index procedure)
- Number of Participants With Post-intervention Secondary Patency(1, 3, 6, 12, 18 and 24 months post index procedure)
- Total Number of Target Lesion Reinterventions(1, 3, 6, 12, 18 and 24 months post index procedure)
- Number of Participants With Technical Success(On Day of Index Procedure)
- Number of Participants With Procedure Success(On Day of Index Procedure)