LDLapheresis-mediated Endothelial activation Therapy to Severe-Peripheral Artery Disease study(LETS-PAD study)

JRCT ID: jRCTs032180100

Registered date:29/01/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: conventional therapy-resistant peripheral artery disease (PAD)without hypercholesterolemia
• Date of first enrollment: 28/10/2016
• Target sample size: 35
• Study type: Interventional
• Intervention(s): LDL apheresis is performed once or twice a week for three months (a total of 10 sessions are conducted).

Outcome(s)

Primary Outcome

The followings are examined at baseline and one month after 10th apheresis:
1)ankle brachial pressure index
2)Vascular Quality of Life Questionnaire scores

Secondary Outcome

The followings are examined at baseline, one month after 10th apheresis, and three months after 10th apheresis:

[clinical examination]
(A)objective clinical symptoms
(a)walking distance
(b)leg ulcers
(B)subjective clinical symptoms
(a)Vascular Quality of Life Questionnaire
(b)leg pain in rest
(C)blood examinations
(a)serum lipids
(b)coagulatory/ inflammatory markers
(c)oxidative stress markers
(D)gene expression analysis in peripheral white blood cells

[physical examination]
(a)pulse wave velocity
(b)central blood pressure
(c)cardio-ankle vascular index
(d)endothelium function (reactive hyperemia peripheral arterial tonometry)
(e)skin perfusion pressure
(f)leg CT angiography (or leg MRA)
(g)ankle brachial pressure index

[the presence or absence of lower extremity amputation]

[the change in Fontaine classification]

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both

Include criteria

(1)age between 20 and 80
(2)patients diagnosed as peripheral artery disease
(3)Fontaine classification >=IIB
(4)ankle brachial pressure index <0.7
(5)serum total cholesterol<=220mg/dl and LDL cholesterol<=140mg/dl
(6)PAD refractory to conventional therapy such as percutaneous transluminal angioplasty or bypass graft surgery
(7)PAD resistant to the ameliorations of atherosclerotic risk factors including medication
(8)patients with written informed consent

Exclude criteria

(1)uncontrolled diabetes despite insulin therapy
(2)severe hepatic disorders
(3)inevitable use of ACE inhibitors during the treatment period
(4)ineligible patients judged by physicians

Related Information

• Primary Sponsor: Toya Yoshiyuki
• Source(s) of Monetary Support: Yokohama City University
• Secondary ID(s): UMIN000021684