NCT03041467已完成不适用
Randomized Study of IN.PACT™ AV Access Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon vs. Standard PTA for the Treatment of Obstructive Lesions in the Native Arteriovenous Dialysis Fistulae (AVF)
Medtronic Endovascular49 个研究点 分布在 3 个国家目标入组 330 人开始时间: 2017年4月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 330
- 试验地点
- 49
- 主要终点
- Target Lesion Primary Patency Rate Through 6 Months
研究概览
简要总结
To evaluate the safety and efficacy of the IN.PACT™ AV Access Drug Coated Balloon (DCB) compared to percutaneous transluminal angioplasty (PTA) for treatment of subjects presenting with de novo or non-stented restenotic obstructive lesion of native arteriovenous dialysis fistulae (AVF) in the upper extremity.
详细描述
This is a prospective, global, multi-center, single-blinded, 1:1 randomized clinical trial evaluating the IN.PACT™ AV Access Drug Coated Balloon (DCB) compared to percutaneous transluminal angioplasty (PTA) for treatment of subjects presenting with de novo or non-stented restenotic obstructive lesion of native arteriovenous dialysis fistulae (AVF) in the upper extremity. The trial will be conducted in up to 30 sites in the United States, Japan, and New Zealand.
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
- Single (Participant)
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 life expectancy of ≥ 12 months
- •Patient has a native AV fistula created ≥ 60 days prior to the index procedure
- •The target AV fistula has undergone successful dialysis for at least 8 of 12 sessions during a four week period
- •Patient has a de novo and/or non-stented restenotic lesion located between the arteriovenous anastomosis and axillosubclavian junction with ≥50% stenosis. Note: If the lesion is located in the anastomosis, the treatment may be delivered up to 2 cm upstream on the arterial side. If the lesion is located in the cephalic arch, the treatment may be delivered up to 2 cm into the subclavian vein
- •Patient has a target lesion or a tandem lesion that is ≤ 100 mm in length (by visual estimate) Note: Tandem lesions may be enrolled provided they meet all of the following criteria: Separated by a gap of ≤ 30mm (3 cm), total combined lesion length, including 30 mm gap, ≤ 100 mm, and 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 high pressure PTA balloon defined as: residual stenosis of ≤ 30% and absence of a flow limiting dissection (Grade ≥ C) or perforation
- •Patient provides written consent prior to enrollment in the study
- •Patient is willing to comply with all follow-up evaluations at specified times
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 is anticipating a kidney transplant within 6 months of enrollment into the study
- •Patient has undergone prior intervention of access site within 30 days of index procedure
- •Patient with anticipated conversion to peritoneal dialysis
- •Patient has an infected AV access or systemic infection
- •Patient has planned surgical revision of access site
- •Patient with secondary non-target lesion requiring treatment within 30-days post index procedure
- •Patient with hemodynamically significant central venous stenoses that cannot be successfully treated prior to treatment of the target lesion
- •Patient with target AVF or access circuit which previously had or currently has a thrombosis
- •Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the delivery system
- •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
- •Patient has presence of a stent located in the target AV access circuit
- •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 with clinically significant Steal Syndrome requiring treatment
- •Patient is enrolled in another investigational drug, device, or biological study and has not completed the primary endpoint, or was previously enrolled in this study
- •Patient has a comorbid-condition that, in the judgment of the Investigator, may cause him/her to be non-compliant with the protocol of confound data interpretation
结局指标
主要结局
Target Lesion Primary Patency Rate Through 6 Months
时间窗: 6 Months Post-Procedure
Freedom from clinically-driven target lesion revascularization (CD-TLR) or access circuit thrombosis measured through 6 months post-procedure.
Primary Safety Endpoint - Serious Adverse Event Rate
时间窗: 30 days post procedure
Serious Adverse Event (SAE) rate involving the AV access circuit
次要结局
- Access Circuit Primary Patency(3, 6, 9, 12, 18, and 24 Months)
- Target Lesion Primary Patency(3, 9, 12, 18, and 24 Months)
- Cumulative Target Lesion Revascularizations(3, 6, 9,12, 18, and 24 Months)
- Device Success(Time of Procedure)
- Clinical Success(From the time of the index procedure to the first successful dialysis session after index procedure. Typically, this is within 1 week of index procedure.)
- Cumulative Access Circuit Thromboses(3, 6, 9, 12, 18, and 24 Months)
- Total Number of Interventions Required to Maintain Access Circuit Patency(3, 6, 9, 12, 18, and 24 Months)
- Procedure Related Adverse Event Rate(30 Days, 3, 6, 9, 12, 18, and 24 Months)
- Clinically-Driven Target Lesion Revascularizations (CD-TLR)(6, 9, 12, 18, 24, and 36 Months)
- Total Number of Interventions Required to Maintain Target Lesion Patency(3, 6, 9, 12, 18, and 24 Months)
- Target Lesion Revascularizations (TLR)(6, 9, 12, 18, 24, and 36 Months)
- Re-interventions in the Access Circuit(6, 9, 12, 18, 24, and 36 Months)
- Abandonment of Target AVF(6, 9, 12, 18, 24, and 36 Months)
- Serious Adverse Event Rate(6, 12, 24, and 36 Months)
- Procedure Success(Time of Procedure)
- Rate of Freedom From All-Cause Mortality Post Vital Status Update(6, 12, 24, 36, 48, and 60 Months)
- Rate of Device Related Adverse Events(30 days, 3, 6, 9, 12, 18, and 24 Months.)
研究者
研究点 (49)
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