NCT05284240已完成不适用
Prospective, Multi-center, Single-arm Study of the Auryon Laser System for Treatment of Below-the-Knee (BTK) Arteries
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- The Primary Performance Endpoint:
研究概览
简要总结
The Auryon Laser Atherectomy System has been cleared by the FDA to treat infrainguinal arterial disease including in-stent restenosis
详细描述
To observe the treatment effects of the Auryon Laser Atherectomy System in treating Infrapopliteal peripheral arterial disease
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is 18 years of age or older.
- •Critical limb ischemia (CLI) in the target limb from the distal segment (P3) of the popliteal artery to the ankle joint prior to the study procedure with Rutherford Category 4-5 in the target limb from the distal segment (P3) of the popliteal artery to the ankle joint prior to the study procedure.
- •Patient has signed approved informed consent.
- •Patient is willing to comply with the follow-up evaluations Angiographic Inclusion Criteria
- •Target lesions(s) must be viewed angiographically and have ≥50% stenosis. More than one lesion can be included in the same vessel.
- •Only 1 target vessel is included in the study.
- •Intraluminal crossing of the lesion. If this is not certain, IVUS may be used to verify this per operator's discretion.
- •Target Lesion reference vessel diameter (RVD) between 1.5 mm - 4.5 mm. by investigator estimate.
- •Target lesion is denovo or restenotic.
排除标准
- •Target lesion is in a vessel graft or synthetic graft.
- •Subjects requiring dialysis.
- •Subject is unable to understand the study or has a history of non-compliance with medical advice.
- •Subject is unwilling or unable to sign the Informed Consent Form (ICF)
- •Subject is currently enrolled in another clinical investigational study that might clinically interfere with the current study endpoints.
- •Subject has a known sensitivity to contrast media and the sensitivity cannot be adequately pre-medicated for.
- •Subject has a CVA or TIA within 4 weeks prior to the Auryon procedure.
- •Planned Use of another debulking device or specialty balloons before or after the Auryon laser during the index procedure
- •Patient has any planned surgical intervention or endovascular procedure ≤14 days after the index procedure or had these procedures in the past 14 days
- •Life expectancy of less than one year judged by the investigator
- •Patient unable to take anticoagulant or antiplatelet agents
- •Platelet count less than 80,000K or bleeding disorders
- •Subject is suspected of having an active systemic infection.
- •Patient enrolled once already in the protocol
- •Planned major amputation of either leg.
- •Acute limb ischemia
- •Current Covid-19 Infection or history of Covid-19 in the past 30 days.
- •Subject is pregnant or planning on becoming pregnant.
- •Vulnerable patients who are unable to give informed consent on their own Pregnant and Vulnerable Populations. There will be no female patients who are pregnant or any vulnerable populations enrolled in the study.
- •Subject experiencing ongoing cardiac problems that per the investigator judgment would not make the subject ideal per the procedure
- •Subject has evidence of intracranial or gastrointestinal bleeding within the past 3 Angiographic Exclusion Criteria
- •Failure to treat clinically significant inflow lesions in the contralateral iliac, ipsilateral iliac, femoral, or P1-P2 segments of the popliteal arteries with ≤ 30 % residual stenosis, and no serious angiographic complications (e.g., embolism)
- •Failure to successfully treat significant non-target infra-popliteal lesions prior to treatment of the target lesion. Successful treatment is defined as obtaining ≤ 50 % residual stenosis with no serious angiographic complications (e.g., embolism).
- •Failure to successfully cross the guidewire across the target lesion; successful crossing is defined as tip of the guidewire distal to the target lesion in the absence of flow limiting dissections or perforations.
- •In-stent restenosis.
结局指标
主要结局
The Primary Performance Endpoint:
时间窗: Index Procedure
Procedure Success defined as ≤30% residual stenosis for the treated segment of the vessel without serious angiographic complications (flow-limiting dissection (D to F), perforation, distal embolization, or acute vessel closure after final treatment, as assessed by the angiographic core lab.
The Primary Safety Endpoint:
时间窗: 30 days
Major Adverse Limb Events (MALE) + Post-Operative Death (POD) at 30 days, as adjudicated by the CEC, defined as a composite of: 1. All-cause death 2. Above-ankle amputation of the index limb 3. Major reintervention (new bypass graft, jump/interposition graft revision, or thrombectomy/thrombolysis) of the index limb involving a BTK artery
次要结局
- EQ-5D-5L Questionnaire(30 days, 3, 6, and 12 months)
- Major Adverse Events (MAE)(30 days)
- Ankle-brachial Index (ABI) or Toe-brachial Index (TBI)(30 days, 6 and 12 months)
- Subgroup analysis stratified by IVUS(Index Procedure)
- Mean Lesion Diameter(Index Procedure)
- Total Dissections(Index Procedure)
- Primary patency at 6 and 12 month(6 and 12 months)
- Serious angiographic complications(Index Procedure)
- Technical success(Index Procedure)
- Perforations(Index Procedure)
- Clinically Relevant Target Lesion Revascularization(12 months)
- Walking impairment questionnaire(30 days, 3, 6, and 12 months)
- Rutherford Category(30 days, 3, 6, and 12 months)
- Healed Wounds(30 days, 3, 6, and 12 months)
研究者
研究点 (4)
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