LDLapheresis-mediated Endothelial activation Therapy to Severe-Peripheral Artery Disease study

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000021684

Enrollment

Registered

2016-04-01

Start date

2016-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

conventional therapy-resistant peripheral artery disease (PAD)without hypercholesterolemia

Interventions

LDL apheresis is performed once or twice a week for three months (a total of 10 sessions are conducted).

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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]	—

Measure

Time frame

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]

—

Countries

Japan

Contacts

Public ContactKouichi Tamura

Yokohama City University Hospital Department of Medical Science and Cardiorenal Medicine

tamukou@yokohama-cu.ac.jp045-787-2635

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026