The THOR IDE Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 155
- 试验地点
- 37
- 主要终点
- Freedom from Major Adverse Events (MAEs)
研究概览
简要总结
The goal of this clinical trial is to test the Thor system in adult (≥ 18 year old) patients with de novo (new, never treated) calcified lesions in infrainguinal (leg) arteries (peripheral artery disease or PAD).
The main question[s] it aims to answer are:
- Is the Thor system safe in treating these lesions
- Does the Thor system work to treat these lesions
Participants will:
- Receive treatment with the Thor system
- Have follow-up visits at Discharge, 30 days, 6 months, and 12 months
详细描述
Up to 30 sites in the U.S. will be selected to do this study.
Patients with pain in their legs when walking and/or resting that is due to lack of blood flow to their legs may be able to join the study. To join the study patients must also have blockages in their leg arteries that meet the study criteria.
Before the Thor procedure, patients will have a screening visit that includes a review of their medical records, questions about their medical history and medications taken for blood thinning or circulation, a physical examination of their legs, a test to check the blood flow in their legs (by checking arm and leg blood pressures), blood tests, and a pregnancy test if they are a female able to have children. Patients will also answer questions about any trouble they have had with walking in the last week and their overall quality of life.
All patients in the study will have treatment with the Thor system. There is no "control group" (a group of patients that receives only standard treatment or receives no treatment at all) in this study. During the procedure, the doctor will take x-ray pictures of the leg arteries. They may also use other treatments such as angioplasty balloons, drug-coated balloons, stents, and filters that collect blood clots, if needed.
Patients treated with the Thor system will be watched until they are ready to go home or up to 24 hours after the procedure if they do not go home right away. Before they go home they will have a test to check the blood flow to their legs (by checking arm and leg blood pressures) and be checked for any adverse events.
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
- 否
入选标准
- •Patient age is ≥18 years
- •Patient agrees to participate and to comply with the protocol by signing an IRB approved patient consent form
- •Patient is able to walk unassisted or with non-motorized assistive devices
- •Patient has PAD with documented Rutherford Class 2-4 of the target limb
- •Anticipated life expectancy >12 months, in the opinion of the investigator at the time of enrollment.
- •Angiographic Inclusion Criteria:
- •Patient has de novo atherosclerotic disease of the native SFA and/or the popliteal arteries
- •Target lesion has ≥70% diameter stenosis by investigator via visual assessment
- •Target lesion length ≤150mm. Total treatment zone may not exceed 150mm, and may include one or more lesions.
- •Chronic total occlusion lesion length is <100mm of the total ≤150mm target lesion
- •Minimum reference vessel diameter (RVD) 4.0mm by visual estimate
- •Target lesion crossed and intraluminal guidewire placement confirmed; successful crossing defined as tip of the guidewire distal to the target lesion in the absence of flow limiting dissections or perforations
- •At least one patent tibial vessel (defined as <50% stenosis) with runoff to the foot
- •Target lesion has moderate to severe calcification graded using the Peripheral Academic Research Consortium (PARC) criteria
排除标准
- •Patient has active infection requiring antibiotic therapy
- •Stenting planned within the target lesion
- •Known positive for COVID-19 within the last 2 weeks and actively symptomatic
- •Pregnant (positive pregnancy test) or currently breast feeding
- •Evidence of Acute Limb Ischemia in the target limb within 7 days prior to procedure
- •Cerebrovascular accident (CVA) <60 days prior to procedure
- •Myocardial infarction <60 days prior to procedure
- •History of unstable coronary artery disease or other uncontrollable comorbidity resulting in hospitalization within the last 60 days prior to baseline screening
- •Known contraindication to aspirin, or antiplatelet/anti-coagulant therapies required for procedure/follow-up
- •Known allergy to contrast media that cannot adequately be premedicated prior to study procedure
- •History of Thrombophilia, Heparin-induced Thrombocytopenia (HIT), or Heparin-induced Thrombotic Thrombocytopenia Syndrome (HITTS)
- •Serum creatinine ≥2.5mg/dL (unless dialysis-dependent) tested within 30 days prior to procedure
- •Planned lower limb major amputation (above the ankle)
- •Other surgical or endovascular procedure in the target limb that occurred within 14 days prior to index procedure or is planned on target limb for within 30 days following index procedure, with the exception of diagnostic angiography
- •Currently participating in any investigational device or drug clinical trial that, in the opinion of the investigator, will interfere with the conduct of the current study
- •The use of specialty balloons, re-entry or additional atherectomy devices is required for treatment of the target lesion.
- •Angiographic Exclusion Criteria:
- •Subject has significant stenosis (>50% stenosis) or occlusion of inflow tract before target treatment zone (e.g. iliac or common femoral) not successfully treated.
- •Subject requires treatment of a peripheral lesion on the ipsilateral limb distal to the target site at the time of the index procedure.
研究组 & 干预措施
Thor Treatment
Treatment with the Thor system
干预措施: Thor laser atherectomy (Device)
结局指标
主要结局
Freedom from Major Adverse Events (MAEs)
时间窗: 30 Days
Defined as freedom from MAEs including all-cause mortality, clinically driven target lesion revascularization (CD-TLR), unplanned target limb major amputation, perforations, flow-limiting dissections, and symptomatic distal embolizations that require an intervention to resolve
Procedural Success
时间窗: At completion of the procedure
Defined as residual diameter stenosis ≤50% at the end of the procedure as determined by angiographic core lab
次要结局
- Target lesion patency, 30 days(30 days)
- Target lesion patency, 6 months(6 months)
- Target lesion patency, 12 months(12 months)
- Clinically-driven target lesion revascularization(Through 12 months)
- Technical success(Peri-procedural)
- Frequency of peri-procedural adverse events(Within 24 hours of the procedure)
- Adjunctive devices used with the Thor system(Peri-procedural)
- Target Limb Ankle-Brachial Index (ABI) change, Discharge(Discharge or up to 24 hours after the procedure)
- Target Limb Ankle-Brachial Index (ABI) change, 30 days(30 days)
- Target Limb Ankle-Brachial Index (ABI) change, 6 months(6 months)
- Target Limb Ankle-Brachial Index (ABI) change, 12 months(12 months)
- Rutherford Classification change, 30 days(30 days)
- Rutherford Classification change, 6 months(6 months)
- Rutherford Classification change, 12 months(12 months)
- Freedom from Major Adverse Events (MAEs)(Through 12 months)
- Change in Short Form Health Survey (SF-36) score, 30 days(30 days)
- Change in Short Form Health Survey (SF-36) score, 6 months(6 months)
- Change in Short Form Health Survey (SF-36) score, 12 months(12 months)
- Change in Walking Impairment Questionnaire (WIQ) score, 30 days(30 days)
- Change in Walking Impairment Questionnaire (WIQ) score, 6 months(6 months)
- Change in Walking Impairment Questionnaire (WIQ) score, 12 months(12 months)