NCT01319812已完成2 期
The Treatment of Iliac and Femoral Atherosclerotic Lesions Using the Self-expanding Astron and Pulsar Stents
适应症
干预措施
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
- •To support the objectives of this study, the following initial inclusion criteria must be met for a subject to be enrolled and considered for the index procedure:
- •Age ≥ 18 years
- •Willingness to comply with study follow-up requirements
- •Candidate for PTA
- •Life-style limiting claudication or rest pain with an ABI ≤ 0.9 (resting or exercise). Thigh brachial index (TBI) may be used / performed if ABI is inadequate.
- •Written informed consent
- •For a subject to receive an investigational stent, the following procedure-related criteria must be met:
- •One de novo, restenotic or occluded lesion representing a femoro-popliteal or iliac indication OR Two de novo, restenotic or occluded lesions representing one femoro-popliteal indication and one iliac indication on contralateral limbs - (i.e. one lesion per limb)
- •Lesions may be one solid lesion or a series of multiple, smaller lesions to be treated as one lesion
- •Subjects with bilateral, SFA/PPA disease (i.e. one SFA/PPA lesion per limb) are eligible for enrollment into the study. The target lesion will be selected at the investigator's discretion based on study eligibility criteria. The contralateral SFA/PPA intervention may be performed at the time of the index procedure (prior to treatment of study lesion); however, the use of an investigational treatment is prohibited. If the contralateral SFA/PPA intervention is not performed at the time of the index procedure, the intervention must be performed at least 30 days after the index procedure. The use of an investigational treatment for the contralateral intervention is prohibited.
- •Subjects with bilateral, iliac disease (i.e. one iliac lesion per limb) are eligible for enrollment into the study. The target lesion will be selected at the investigator's discretion based on study eligibility criteria. The contralateral iliac intervention may be performed at the time of the index procedure; however, the use of an investigational treatment is prohibited. If the contralateral iliac intervention is not performed at the time of the index procedure, the intervention must be performed at least 30 days after the index procedure. The use of an investigational treatment for the subsequent contralateral intervention is also prohibited.
- •Femoro-popliteal lesions must be located at least 1 cm distal to the profunda femoris artery and at least 3 cm above the knee joint (radiographic joint space)
- •Iliac lesions must be located only in either the common or external iliac artery
- •Lesions must be treatable with a maximum of two stents
- •Angiographic evidence of ≥ 70% stenosis or occlusion (operator visual assessment)
- •Lesion length ≤ 190 mm (if de novo or restenotic) or ≤ 100 mm (if occluded)
- •Target vessel reference diameter: 2.5 to 6 mm (SFA/PPA) or 6 to 9 mm (iliac arteries) by visual estimate
- •Angiographic evidence of patent SFA and PPA (iliac indication) and angiographic evidence of at least one distal vessel runoff to the foot (both femoro-popliteal and iliac indications). Patent is defined as < 50% stenosis.
- •For SFA/PPA intervention, a significant stenosis (> 70%) or occlusion of an ipsilateral, inflow artery (e.g. aortoiliac, common femoral) must be successfully treated (use of investigational treatment prohibited) just prior to treatment of the target lesion. Successful treatment is defined as no complications and less than 30% residual stenosis following intervention.
排除标准
- •To support the objectives of this study, the following initial exclusion criteria must not be present for a subject to be enrolled:
- •Subjects pregnant or planning to become pregnant during the course of the study
- •Life expectancy of less than one year
- •Rutherford-Becker category 5 or
- •Subjects with ulcers caused by venous disease may be enrolled in the study.
- •Previously stented lesion(s) in the target vessel
- •Target lesion(s) received previous treatment within 30 days prior to enrollment
- •Prior peripheral vascular bypass surgery involving the target limb(s)
- •Thrombophlebitis or deep vein thrombosis within the past 30 days
- •Known allergy to nitinol (nickel and/or titanium)
- •Participation in any other clinical investigational device or drug study. Subjects may be concurrently enrolled in a post-market study, as long as the post-market study device, drug or protocol does not interfere with the investigational treatment or protocol of this study.
- •Previous stroke or transient ischemic attack within the last three months prior to enrollment
- •Previous coronary or peripheral bypass surgery (non-target limb) within 30 days prior to enrollment
- •Intolerance to contrast agents that cannot be medically managed and/or intolerance to anti-platelet, anti-coagulant or thrombolytic medications
- •Refuses blood transfusions
- •Any medical condition, that in the opinion of the investigator, poses an unacceptable risk for implant of a stent according to the study indications
- •For a subject to receive an investigational stent the following procedure-related criteria must not be present:
- •INR ≥ 1.6
- •Concomitant renal failure with serum creatinine level > 2.5 mg/dL
- •Unresolved neutropenia (white blood cell count < 3,000 / µL) or thrombocytopenia (platelet count < 80,000 / µL) at the time of the index procedure
- •Unresolved bleeding disorder (INR ≥ 1.6) at the time of the index procedure
- •Presence of other ipsilateral, arterial lesions distal to the target lesion requiring treatment within 30 days of the index procedure (either before or after) or at the time of the index procedure
- •Additional percutaneous interventional procedures (cardiac and/or peripheral) planned within 30 days after the index procedure
- •Presence of a complication following pre-dilation of target lesion
- •Presence of a target vessel/lesion that is excessively tortuous or calcified or is adjacent to an acute thrombus that is unresponsive to anti-thrombotic therapies
- •Target lesion is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion
- •Target lesion requires the use of cutting balloons, atherectomy or ablative devices
- •Subjects with less than single vessel runoff to the foot
研究组 & 干预措施
Astron Stent Group
Experimental
Participants indicated for stenting in iliac atherosclerotic lesions.
Intervention: Device: Astron Stents
干预措施: Astron Stents (Device)
Pulsar Stent Group
Experimental
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
- 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)
- 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 - 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)
研究者
研究点 (35)
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