Intravascular Ultrasound IMaging vs Angiography-Guided EVT in Below-the-Knee Arteries
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 212
- 试验地点
- 4
- 主要终点
- Primary patency at 6 months
研究概览
简要总结
Chronic limb-threatening ischemia (CLTI) is a severe form of peripheral artery disease in which very poor blood flow in the arteries below the knee can cause rest pain, non-healing wounds, and even loss of the limb. It is often treated with endovascular therapy (EVT), a minimally invasive procedure that opens the blocked artery, but the artery frequently narrows or closes again afterward. These procedures are usually guided by X-ray pictures taken with dye (angiography). Intravascular ultrasound (IVUS) is an imaging tool that uses a small catheter inside the artery to give a more detailed view of the vessel, which may help doctors open it more completely. It is not yet clear whether adding IVUS improves results below the knee.
This study is testing whether guiding treatment with IVUS plus angiography keeps the artery open better than angiography alone. Adults aged 18 or older with CLTI who are having endovascular therapy for a blocked artery below the knee may take part. Participants are assigned by chance to be treated with either both imaging methods or angiography alone, and are followed for 12 months. The main question is how well the treated artery stays open at 6 months; researchers will also compare repeat procedures, amputation, complications, wound healing, survival, and quality of life.
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
- Double (Participant, Outcomes Assessor)
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
- •Age ≥18 years.
- •Documented chronic limb-threatening ischemia, meeting the following criteria according to guidelines(13):
- •Presence of ischemic symptoms compatible with CLTI, defined as arterial insufficiency with gangrene, non-healing ischemic ulcer, or rest pain consistent with Rutherford classes 4-5 AND
- •Imaging evidence within the past 12 months showing atherosclerotic PAD, including CTA, MRA, angiography or duplex ultrasound AND
- •Ankle-Brachial Index (ABI) ≤0.80 or Toe-Brachial Index (TBI) ≤0.60 for patients who never underwent revascularization; ABI ≤0.85 or TBI ≤0.65 for those with history of prior revascularization procedures OR
- •Ischemic rest pain alone (Rutherford class 4) with ankle systolic pressure <50 mmHg, toe pressure of <30 mmHg, transcutaneous PO2 of <30 mmHg, or flat-line transtarsal pulse volume recording OR
- •Tissue loss with or without ischemic rest pain (Rutherford class 5) with ankle systolic pressure <70 mmHg, toe pressure of <50 mmHg, transcutaneous PO2 of <30 mmHg, or flatline transtarsal pulse volume recording
- •Absence of occlusive upstream disease, defined by the following:
- •Demonstrated vascular patency from the aorta to the second segment of the popliteal artery (P2), either by angiography, duplex ultrasound, CTA or MRA within the last 7 days prior to randomization
- •In patients who underwent prior treatment for upstream disease, there are no restrictions in treatment modalities received as long as patency is demonstrated as previously defined
- •If upstream disease is planned to be treated in the same index procedure, technically successful treatment of the upstream vessels must be achieved before randomization, defined as less than 30% residual stenosis and no flow-limiting dissections
- •Informed Consent:
- •Demonstrated ability and willingness to adhere to the study protocol and provide written informed consent
排除标准
- •Age <18 years
- •Asymptomatic or mild disease: patients who underwent revascularization for disease graded Rutherford classes 0-3
- •Patients with major tissue loss (Rutherford 6) in whom major amputation was planned at the time of screening
- •Patient with a history of prior major (above-the-ankle) amputation of the study limb
- •Unable to tolerate any antiplatelet agent or with severe bleeding diathesis
- •Clinical signs of active, uncontrolled, severe limb infection or septicemia, defined as fever exceeding 38.5°C, a white blood cell count above 15,000 cells/µL, or hypotension, at the time of screening (this does not include osteomyelitis confined to the phalanges or metatarsal heads or foot cellulitis treatable with IV antibiotics at the time of revascularization)
- •Acute coronary syndrome or acute stroke within 30 days of screening
- •Active hepatitis or severe liver cirrhosis (Child Pugh C)
- •Advanced CKD (defined with eGFR<30 mL/min/1.73m2) or end-stage renal disease
- •Pregnancy, breastfeeding, or women of childbearing potential who are not using an effective method of contraception
- •Previous (within 30 days) or concomitant participation in another clinical study with investigational medicinal product(s) that has not yet reached its primary endpoint
- •Life expectancy <1 year
结局指标
主要结局
Primary patency at 6 months
时间窗: 6 months after the index procedure
Freedom from clinically driven target lesion revascularization (CD-TLR), total occlusion of the target vessel, or binary restenosis of the target lesion. Binary restenosis is defined as a peak systolic velocity ratio \>2.0 on duplex ultrasound. Reported as the proportion of participants meeting all three criteria.
次要结局
- Major amputation of the study limb(12 months)
- Major adverse limb events (MALE)(12 months)
- Composite freedom from limb events(12 months)
- Wound healing (Rutherford class 5 participants)(1, 3, 6, 9, and 12 months)
- Time to complete wound healing (Rutherford class 5 participants)(From the index procedure to 12 months)
- Major adverse cardiovascular events (MACE)(12 months)
- Acute limb ischemia(12 months)
- Limb-related mortality(12 months)
- All-cause mortality(12 months)
- Periprocedural complications(During the index procedure through 30 days)
- Disagreement in imaging findings between angiography and IVUS(During the index procedure (Day 0))
- Procedural success(During the index procedure (Day 0))
- Procedure time(During the index procedure (Day 0))
- Contrast use(During the index procedure (Day 0))
- Change in quality of life(Baseline, 1, 3, 6 and 12 months)
- Change in ankle-brachial index(Baseline, 1, 3, 6, 9 and 12 months)
- Change in toe-brachial index(Baseline, 1, 3, 6, 9 and 12 months)
- Change in transcutaneous oxygen pressure(Baseline, 1, 3, 6, 9 and 12 months)
研究者
Donna Shu-Han Lin
Dr
Shin Kong Wu Ho-Su Memorial Hospital