NCT04543539进行中（未招募）不适用
IN.PACT™ AV Access Post-Approval Study (PAS002)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Medtronic
- 入组人数
- 240
- 试验地点
- 20
- 主要终点
- Infection and Infestations Serious Adverse Events
研究概览
简要总结
Long-term safety will be summarized
详细描述
The purpose of this study is to evaluate the long-term safety of the IN.PACT™ AV Access Drug Coated Balloon (DCB) for treatment of subjects presenting with de novo or non-stented restenotic obstructive lesion of native arteriovenous dialysis fistulae (AVF) in the upper extremity. Patients will be followed for five years. The IN.PACT™ AV Access PAS 002 is required by the Food and Drug Administration (FDA) as a condition of product approval. This study is conducted within Medtronic's post market surveillance platform.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patient is ≥ 21 years of age
- •Patient has a mature native AV fistula created ≥ 60 days prior to the index procedure
- •Patient has a de novo and/or non-stented restenotic lesion located between the arteriovenous anastomosis and axillosubclavian junction
- •Patient has a target lesion or a tandem lesion that is ≤ 100 mm in length (by visual estimate) Note: Tandem lesions may be included provided they meet all of the following criteria: a. Separated by a gap of ≤ 30 mm (3 cm), b. Total combined lesion length, including 30 mm gap, ≤ 100 mm, c. Able to be treated as a single lesion
- •Patient has a target vessel diameter of 4.0 - 12.0 mm (by visual estimate)
- •Patient underwent successful crossing of the target lesion with the guide wire and pre-dilatation with a PTA balloon defined as: Residual stenosis of ≤ 30% AND Absence of a flow limiting dissection or perforation AND No extravasation requiring treatment
- •Primary Cohort
排除标准
- •Women who are breastfeeding, pregnant, or are intending to become pregnant, or men intending to father children
- •Patient is receiving immunosuppressive therapy
- •Patient has an infected AV access or systemic infection
- •Patient with hemodynamically significant central venous stenoses that cannot be successfully treated prior to treatment of the target lesion
- •Patient with target lesion located central to the axillosubclavian junction
- •Patient has significant arterial inflow lesion requiring treatment more than 2 cm upstream from the anastomosis in the AV access
- •Patient has presence of pseudoaneurysm or aneurysm requiring treatment at the lesion site
- •Target lesion is located within a bare metal or covered stent
- •Patients with known allergies or sensitivities to paclitaxel
- •Patient with known contraindication, including allergic reaction, or sensitivity to contrast material that cannot be adequately pre-treated
- •Patient who cannot receive recommended antiplatelet and/or anticoagulant therapy
- •Patient is enrolled in another investigational drug, device, or biologic study and has not completed the primary endpoint, or was previously enrolled in this study
- •Patient has a co-morbid condition that, in the judgment of the Investigator, may cause him/her to be non-compliant with the protocol or confound the data interpretation
- •Patient has an active COVID-19 infection with ongoing sequela at enrollment or hospitalization for treatment of COVID-19
- •Inclusion Criteria for Extended Cohort:
- •Patient is ≥ 21 years of age
- •Exclusion Criteria for Extended Cohort:
- •Patient has an active COVID-19 infection with ongoing sequela at enrollment or hospitalization for treatment of COVID-19
结局指标
主要结局
Infection and Infestations Serious Adverse Events
时间窗: Through 12 months post-index procedure
Demonstrate Infection and Infestations Serious Adverse Events, including pneumonia, meets the performance goal of 30% in the primary cohort.
次要结局
- Mortality Rate(Through 1, 2, 3, 4, and 5 years post-index procedure)
研究者
研究点 (20)
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