跳至主要内容
临床试验/NCT06014242
NCT06014242撤回不适用

Peripheral Microvascular Resistance as a Predictor for Limb Salvage in Post-Intervention Critical Limb Ischemia Patients

Hackensack Meridian Health0 个研究点目标入组 40 人开始时间: 2025年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
入组人数
40
主要终点
Efficacy of the peripheral flow reserve

研究概览

简要总结

Salvaging a threatened limb is the key therapeutic objective for patients with critical limb ischemia, and the achievement of limb salvage is an independent predictor of patient morbidity and mortality. Despite successful primary endovascular or surgical intervention, the corresponding symptoms of rest pain and/or non-healing ulceration in some patients may continue, and amputation in these patients is unavoidable. It is hypothesized that the functional integrity of the peripheral vascular microcirculation may be impaired in these patients. However, there are currently no techniques that allow direct quantification and visualization of the microcirculation due to the micro-vessel invisibility under angiography.

In the coronary circulation, coronary flow reserve (CFR) indicates the capacity for maximal hyperemic blood flow and reveals impaired coronary microvascular function. Studies have shown the clinical significance of measuring microvascular resistance to predict myocardial salvage after myocardial infarction. The study will explore whether this concept of coronary flow reserve can be applied peripherally to patients with critical limb ischemia in order to determine whether measuring peripheral vascular flow reserve can determine the integrity of the microcirculation to predict limb salvage after endovascular intervention.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

入选标准

  • Chronic critical limb ischemia (Rutherford 4-6).
  • Age ≥18 years
  • Ability and willingness to sign the IRB approved Informed Consent form

排除标准

  • Non-reconstructable chronic total occlusive disease of the proximal inflow vessels that would make flow reserve measurements impossible.
  • Non-salvageable lower extremity due to infection or overwhelming per-existing tissue loss (most critical Rutherford 6 patients).
  • Inability to understand the study or a history of non-compliance with medical advice;
  • History of any cognitive or mental health status that would interfere with study participation;
  • Currently enrolled in any pre-approval investigational study.
  • Female subjects who are pregnant or nursing or planning to become pregnant within the study period;
  • Known sensitivity to contrast media, which can't be adequately pre-medicated;
  • Expected life span less than 6 months.
  • Unable to read/understand/sign the English Language consent form

结局指标

主要结局

Efficacy of the peripheral flow reserve

时间窗: 6 months post-endovascular intervention

To assess whether peripheral flow reserve can predict the success rate of limb salvage in critical limb ischemia patients after endovascular intervention. Assessed by any amputation (major or minor) at 6 months post-endovascular intervention.

次要结局

  • Rutherford classification (6m)(6 months post-endovascular intervention)
  • Transcutaneous oxygen partial pressure (TcPO2) (6m)(6 months post-endovascular intervention)
  • Target lesion revascularization (1m)(At 1 month post-endovascular intervention)
  • Number of patients with Symptom resolution - Pain (1m)(1 month post-endovascular intervention)
  • Ankle-brachial index (ABI) (6m)(6 months post-endovascular intervention)
  • Toe-brachial index (TBI) (6m)(6 months post-endovascular intervention)
  • Symptom resolution - Ulcer healing (1m)(1 month post-endovascular intervention)
  • Rutherford classification (1m)(1 month post-endovascular intervention)
  • Transcutaneous oxygen partial pressure (TcPO2) (1m)(1 month post-endovascular intervention)
  • Symptom resolution - Ulcer healing (6m)(6 months post-endovascular intervention)
  • Number of patients with Symptom resolution - Pain (6m)(6 months post-endovascular intervention)
  • Ankle-brachial index (ABI) (1m)(1 month post-endovascular intervention)
  • Toe-brachial index (TBI) (1m)(1 month post-endovascular intervention)
  • Target lesion revascularization (6m)(At 6 month post-endovascular intervention)

研究者

申办方类型
Other
责任方
Sponsor

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