Prospective, Multi-Center Clinical Study of the Bard® COVERA™ Arteriovenous (AV) Stent Graft in the Treatment of Stenosis at the Graft-Vein Anastomosis of AV Graft Circuits (AVeVA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 32
- 主要终点
- Number of Participants With Freedom From AV Access Circuit Localized or Systemic Serious Adverse Events
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 safety and effectiveness performance goals (PGs) for the treatment of stenotic lesions in the upper extremity venous outflow of the arteriovenous (AV) access circuit of subjects dialyzing with an AV graft.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 clinical and telephone follow-up.
- •Subject must have a synthetic AV access graft located in an arm that has been implanted for ≥ 30 days and must have undergone at least one successful dialysis session prior to the index procedure.
- •Angiographic Inclusion Criteria
- •Subject must have angiographic evidence of a stenosis ≥ 50% (by visual estimation) located at the graft-vein anastomosis of the subject's synthetic AV access graft and present with clinical evidence of graft dysfunction at the synthetic AV graft-vein anastomosis.
- •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 vessel must be between 5.0 and 9.0mm.
排除标准
- •The subject is dialyzing with an AV fistula.
- •The hemodialysis access is located in the lower extremity.
- •The subject has an infected AV access graft 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 or stent graft.
- •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 implantation of the study device.
结局指标
主要结局
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.
Effectiveness Endpoint: Number of Participants With Target Lesion Primary Patency
时间窗: 6 months post index procedure
Target Lesion Primary Patency (TLPP) is defined as the interval following the index intervention until the next clinically driven reintervention at 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 access graft due to inability to treat the original treatment area. The primary effectiveness endpoint is evaluated against a performance goal (PG) of 40%.
次要结局
- Endpoint Without Hypothesis Testing: Total Number of Arteriovenous (AV) Access Circuit Reinterventions(1, 3, 6, 12, 18 and 24 months post index procedure.)
- Endpoint Without Hypothesis Testing: Total Number of Target Lesion Reinterventions(1, 3, 6, 12, 18 and 24 months post index procedure)
- Endpoint Without Hypothesis Testing: Number of Participants With Post-intervention Secondary Patency(1, 3, 6, 12, 18 and 24 months post index procedure)
- Endpoint Without Hypothesis Testing: Number of Participants With Technical Success (for Stent Graft Placement)(At time of index procedure)
- Endpoint Without Hypothesis Testing: Number of Participants With Target Lesion Primary Patency (TLPP)(1, 3, 6, 12, 18 and 24 months post index procedure)
- Endpoint Without Hypothesis Testing: Number of Participants With Device and Procedure Related AEs Involving the AV Access Circuit(1, 3, 6, 12, 18 and 24 months post index procedure,)
- Endpoint With Hypothesis Testing: Number of Participants With Access Circuit Primary Patency (ACPP)(1, 3, 6, 12, 18 and 24 months post index procedure)
- Endpoint Without Hypothesis Testing: Index of Patency Function (IPF)(1, 3, 6, 12, 18 and 24 months post index procedure)
- Endpoint Without Hypothesis Testing: Index of Patency Function - Target Lesion (IPF-T)(1, 3, 6, 12, 18 and 24 months post index procedure)
- Endpoint Without Hypothesis Testing: Number of Participants With Procedure Success(At time of index procedure)