NCT06979284招募中不适用
Intravascular Ultrasound for Peripheral Artery Disease Revascularization: The CLARITY Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 772
- 试验地点
- 5
- 主要终点
- Time-to-first occurrence of MALE
研究概览
简要总结
The purpose of this study is to determine if IVUS use, as compared to angiography alone, prevent major adverse limb events (MALE) or binary restenosis (a greater than 50% re-narrowing of the treated artery) in adult patients who have CLTI and are undergoing percutaneous revascularization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (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
- •Patients presenting with lower extremity PAD manifesting as CLTI:
- •a. CLTI is defined as ischemic rest foot pain, nonhealing wounds, or gangrene present for at least two weeks and that is attributable to objectively proven arterial occlusive disease, compatible with Rutherford class 4, 5 or 6 AND
- •Scheduled to undergo percutaneous revascularization, AND
- •Informed consent
- •Imaging evidence of an obstructive or occluded lesion (> 70%) in the infraiguinal circulation (e.g. femoral, popliteal, or infrapopliteal circulation) using angiography, ultrasound, computed tomography, or magnetic resonance imaging that is responsible for CLTI of the index limb
- •An infrapopliteal lesion must be located in the proximal 2/3 of native infrapopliteal vessels, with a vessel diameter of > 2.5mm by investigator visual assessment.
- •The distal margin of the most distal target lesion must be located > 10 cm proximal to the proximal margin on the ankle mortise. The vessel segment distal to the most distal target lesion must be patent all the way to the ankle, with no obstructive lesion (>50% stenosis).
排除标准
- •The presence of anatomic or comorbid conditions or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the potential participant's ability to participate in the trial or to comply with the follow-up requirements.
- •The presence of any medical conditions precluding percutaneous revascularization
- •The subject has previously had or requires open surgical revascularization involving the vessel containing the target lesion of the ipsilateral extremity.
- •The subject is bedridden or unable to walk (with assistance is acceptable).
- •Life expectancy < 12 months
- •Age < 18 years
- •Active vasculitis, Buerger's disease, or acute limb-threatening ischemia
- •Planned above-ankle amputation of the index limb within four weeks of the index procedure.
- •Obstructive supra-inguinal "inflow" (>70% stenosis) which is not planned to be treated during index procedure or within 30 days of the index procedure.
- •The subject has had any amputation to the ipsilateral extremity other than the toe or forefoot, or the subject has had a major amputation to the contralateral extremity < 1 year before the index procedure and is not independently walking.
- •Extensive tissue loss that is salvageable only with complex foot reconstruction or non-traditional trans metatarsal amputations.
- •Osteomyelitis that extends proximal to the metatarsal heads
- •Gangrene involving the plantar skin of the forefoot, midfoot or heel
- •Deep ulcer or large shallow ulcer (> 3 cm) involving the plantar skin of the f forefoot, midfoot, or heel
- •Full-thickness heel ulcer
- •Any wound with calcaneal bone involvement
- •Wounds that would require flap coverage or complex wound management for large soft tissue defect
- •Full-thickness wounds on the dorsum of the foot with exposed tendon or bone.
研究组 & 干预措施
Intravascular Ultrasound - guided strategy
Active Comparator
Percutaneous revascularization will be performed using intravascular ultrasound.
干预措施: IVUS-guided strategy (Procedure)
Angiography - guided strategy
No Intervention
A standard-of-care percutaneous revascularization will be performed without using intravascular ultrasound.
结局指标
主要结局
Time-to-first occurrence of MALE
时间窗: From date of randomization until the date of first unplanned above ankle amputation of the index limb, clinically driven target lesion revascularization or target-lesion binary restenosis, assessed up to a maximum of 5 years.
Defined as unplanned above ankle amputation of the index limb or clinically driven target lesion revascularization, or target-lesion binary restenosis, defined as \> 50% stenosis on imaging throughout follow-up.
次要结局
- Wound healing status of the index limb based on the Wound, Ischemia, Foot Infection (WIFI) scale at 12 months(From date of randomization, assessed up to a maximum of 1 year)
- Change in the Walking Impairment Questionnaire (WIQ) score at 12 months(From date of randomization, assessed up to a maximum of 1 year)
- Change in the Vascular Quality of Life Questionnaire-6 (VascQol-6) score at 12 months(From date of randomization, assessed up to a maximum of 1 year)
- Unplanned minor amputation of the index limb(From date of randomization, assessed up to a maximum of 5 years.)
- The composite of all-cause mortality, MALE, or target-lesion binary restenosis(From date of randomization until the date of death, MALE, or target lesion binary restenosis, assessed up to a maximum of 5 years.)
- Clinically-driven target lesion revascularization(From date of randomization, assessed up to a maximum of 5 years.)
- MALE(From date of randomization, assessed up to a maximum of 5 years.)
- All-cause mortality(From date of randomization, assessed up to a maximum of 5 years.)
- Unplanned above-ankle amputation of the index limb(From date of randomization, assessed up to a maximum of 5 years.)
- Target lesion binary restenosis(From date of randomization, assessed up to a maximum of 5 years.)
研究者
研究点 (5)
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