The Treatment of Iliac and Femoral Atherosclerotic Lesions Using the Self-expanding Astron and Pulsar Stents
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 463
- 试验地点
- 35
- 主要终点
- Safety and Effectiveness Endpoint for the Astron Stent - Percentage of Participants With Major Adverse Events (MAE)
研究概览
简要总结
The objective of this study is to separately demonstrate the safety and efficacy of BIOTRONIK's Astron and Pulsar stents. The Pulsar stent will be used for the treatment of femoro-popliteal lesions, located in the native superficial femoral artery (SFA) or proximal popliteal artery (PPA), while the Astron stent will be used for the treatment of the common or external iliac artery lesions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Astron Stent Group
Participants indicated for stenting in iliac atherosclerotic lesions.
Intervention: Device: Astron Stents
干预措施: Astron Stents (Device)
Pulsar Stent Group
Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
Intervention: Device: Pulsar Stents
干预措施: Pulsar Stents (Device)
结局指标
主要结局
Safety and Effectiveness Endpoint for the Astron Stent - Percentage of Participants With Major Adverse Events (MAE)
时间窗: 12 months
The primary endpoint for the Astron stent is a composite of the rate of procedure- or stent-related major adverse events at 12 months post-index procedure. The major adverse event rate includes 30-day mortality, along with 12-month rates of target lesion revascularization and index limb amputation. Success was measured against a performance goal of 15%, given a 7.5% expected 12-month MAE rate, with an assumed delta value of 7.5%.
Effectiveness Endpoint for the Pulsar Stent: Primary Patency
时间窗: 12 months
The primary effectiveness endpoint for the Pulsar stent group is the primary patency rate at 12 months post-index procedure. Primary patency is defined as freedom from more than 50% restenosis based on the duplex ultrasound peak systolic velocity ratio, comparing data within the treated segment to the proximal normal segment or based on a clinically-indicated TLR with angiographic evidence of \> 50% stenosis.
Safety Endpoint for the Pulsar Stent: Freedom From Procedure- or Stent-related Major Adverse Events
时间窗: 30 days
The primary safety endpoint for the Pulsar stent is the freedom from procedure- or stent-related major adverse events at 30 days post-index procedure. The major adverse event rate includes mortality, target lesion revascularization and index limb amputation.
Percentage of Participants With Primary Safety Endpoint (Post Market Analysis)
时间窗: 36 Months
Freedom from a composite of clinically-driven target lesion revascularization (TLR) and index limb amputation at 36 months.
次要结局
- Secondary Safety Assessment for the Astron Stent - Distribution of MAE Rate(12 months)
- Functional Assessments for Subjects With the Astron and Pulsar Stents - Ankle - Brachial Index (ABI) Measurement(12 months)
- Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Walking Distance Score(12 months)
- Secondary Effectiveness Assessment for the Astron and Pulsar Stents - Primary Assisted Patency(12 months)
- Functional Assessments for Subjects With the Astron and Pulsar Stents - Six-Minute Walk Test(12 months)
- Clinical Success(30 days)
- Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - 30 Day MAE Rate(30 days)
- Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Acute Procedure Success(Acute / Date of Procedure)
- Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Secondary Patency Rate at 12 Months(12 months)
- Safety Assessment for the Pulsar Stent: Percentage of Participants With Mortality, TLR, and Index Limb Amputation (Post Approval)(24 Months)
- Secondary Safety Assessment for the Pulsar Stent: Individual Rates of Mortality, TLR, and Index Limb Amputation(30 days)
- Stent Integrity Assessment for the Pulsar Stent: Stent Fracture Rate(12 months)
- Secondary Effectiveness Assessment for the Astron and Pulsar Stents - Secondary Patency(12 months)
- Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire PAD Specific Score(12 months)
- Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Primary Patency at 12-months(12 months)
- Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Primary Assisted Patency at 12-Months(12 months)
- Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - 30-Day Clinical Success(30 days)
- Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Stent Fracture Rate at 12 Months(12 months)
- Number of Participants With Stent Fracture at 36 Months (Post Approval) (Pulsar Stent Group).(36 Months)
- Percentage of Subjects With Serious Adverse Events at 36 Months (Post Approval) (Pulsar Stent Group).(36 months)
- Long-Term Safety Assessment for the Pulsar Stent: Major Adverse Event Rate(12 months)
- Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Secondary Patency Rate at 12-Months(12 months)
- Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Primary Patency at 12 Months(12 months)
- Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Acute Procedure Success(Acute / Date of Procedure)
- Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - 30-day Clinical Success(30 days)
- Percentage of Participants With Target Lesion Revascularization (TLR) at 36 Months (Post Approval) (Pulsar Stent Group)(36 Months)
- Secondary Effectiveness Assessment for the Astron Stent - Primary Patency Rate(12 months)
- Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - MAE Rate(12 months)
- Number of Participants With Freedom From Clinically-driven TLR and Index Limb Amputation at 24 Months (Post Approval)(24 Months)
- Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Walking Speed Score(12 months)
- Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Stair Climbing Score(12 months)
- Acute Procedural Success for Astron and Pulsar Stent(30 days)
- Secondary Safety Assessment for Astron and Pulsar Stent: Adverse Event Rates(12 month)
- Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Primary Assisted Patency at 12 Months(12 months)
- Percentage of Participants for the Pulsar Stent Group With MAE (30-day Mortality, Clinically-driven TLR, and Index Limb Amputation) and Their Components at 36 Months (Post Approval).(36 Months)
- Percentage of Participants With Target Lesion Revascularization (TLR) at 24 Months (Post Approval) (Pulsar Stent Group)(24 Months)
- Number of Participants With Stent Fracture at 24 Months (Post Approval).(24 Months)