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NCT Number: NCT06485622

Outcome and Improvement of Different Treatment in Arteriosclerosis Obliterans

This study is a prospective, single-center, observational study. In this study, we aim to evaluate the clinical outcome and cost-effectiveness of different treatments of lower extremity arterial occlusive disease. It is expected to include about 400 patients diagnosed with lower extremity arterial occlusive disease in our center from July 2024 to July 2026. All enrolled patients will be followed for three years. All patients diagnosed with arteriosclerosis obliterans (ASO) and all treatment techniques were included in this study. The primary outcomes include the Efficacy and Safety End Points of each techniques.

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Key information

Conditions

Arteriosclerosis Obliterans Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510030, China

Location status: Recruiting

Location contact

Zilun Li, Doctor

CONTACT

[email protected]

13760871576

About this study

Arteriosclerosis obliterans (ASO) is a kind of lower extremity arterial disease which occurs frequently in middle-aged and elderly people. The incidence of ASO increases with age. In patients with ASO, the build-up of fatty deposits, cholesterol, and other substances (plaques) in the arteries reduces blood flow to the extremities. This can lead to symptoms such as leg pain, cramping, and fatigue, especially during physical activity. In severe cases, it may result in pain at rest, non-healing wounds, and complications such as tissue damage or infection. Chronic wound is one of the symptoms that affect the quality of life. Therefore, wound healing is also an important index for postoperative care. However, no study has reported detailed performance data for different treatments. As an auxiliary method in clinical treatment, nutrition plays an important role in improving the clinical outcome of patients in the development and postoperative stages of the disease. The effect of nutritional risk assessment and nutritional education on postoperative symptoms of ASO has not been reported. Therefore, we plan to carry out this prospective, single-center, observational study, providing new data on the efficacy, safety and cost-effectiveness for different treatment and assistive techniques in lower extremity arterial occlusive disease.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years or older, gender is not limited.
  • Patients diagnosed with arteriosclerosis obliterans.
  • Rutherford stages 2-6.
  • When there are multiple stenosis lesions, the treatment of the most severe lesion is included.
  • Patients with at least one arterial occlusion ( iliac, femoral, popliteal, anterior tibial, posterior tibial, and/or peroneal artery) of the lower extremity were included.

Exclusion criteria

  • Malignant tumor
  • Alzheimer's disease
  • Blood disease or bleeding tendency
  • Heart Failure Grade III ~ IV
  • Pregnancy or lactation
  • An above-knee-below-knee amputation has been performed
  • Unable to accept therapeutic function tests
  • Life expectancy is less than six months
  • Combined with other diseases affecting walking
  • Cardiovascular and cerebrovascular events occurred within 3 months, including non-fatal myocardial infarction, unstable angina, stable angina, non-fatal ischemic stroke and hemorrhagic stroke
  • Patients with significant abnormal liver and renal function that the investigators judged to be clinically significant

Treatment and study plan

open bypass group

Procedure

After heparinization, the target artery is clamped above and below the anastomosis. The target artery is dissected along the anterior wall, calcium portions or mural thrombus are removed. Graft (autologous or prosthetic graft) is cut obliquely and anastomosis suturing starts with distal angle. Next stage is tunnel creating for graft conduction.

bare metal stent group

Procedure

Bare metal stent implantation during the index procedure.

plain old balloon angioplasty group

Procedure

Only plain old balloon was used during the index procedure.

drug-coated balloon group

Procedure

Drug-coated balloon was used during the index procedure.

directional atherectomy group

Procedure

Directional atherectomy (with or without drug-coated balloon) during the index procedure.

hybrid repair group

Procedure

Femoral artery arteriotomy. Further execute a direct endarterectomy femoral artery and from the mouth of a hip artery. Arteriotomy of the femoral artery is closed with a vascular patch use (synthetic or biological). Endovascular revascularization followed.

Primary outcomes

  1. Limb salvage rate

    Time frame: 1 month; 6 months; 12 months; 24 months; 36 months

    Freedom from above ankle amputation in target limb.

  2. Primary patency rate

    Time frame: 1 month; 6 months; 12 months; 24 months; 36 months

    Primary patency of target lesion is assessed by the vascular ultrasound.

  3. Major adverse limb event (MALE) rate

    Time frame: 1 month; 6 months; 12 months; 24 months; 36 months

    Major adverse limb events include anyone of the following: Amputation in target limb and major re-intervention on target limb.

  4. All cause mortality rate

    Time frame: 1 month; 6 months; 12 months; 24 months; 36 months

    Death due to any cause.

Secondary outcomes

  1. Restenosis of the target lesion

    Time frame: 1 month; 6 months; 12 months; 24 months; 36 months

    A peak systolic velocity ratio of over 2.4 measured using duplex ultrasound, >50% diameter stenosis or occlusion by follow-up angiography.

  2. Major adverse cardiovascular events (MACE)

    Time frame: 1 month; 6 months; 12 months; 24 months; 36 months

    Major adverse cardiovascular events include anyone of the following: Major amputations, myocardial infarction, ischemic stroke, arterial puncture problems requiring intervention, and acute kidney failure associated with endovascular therapy.

  3. Quality-adjusted life-years (QALYs)

    Time frame: 1 month; 6 months; 12 months; 24 months; 36 months

    Time is measured in years and the VascuQol (Vascular Quality-of-Life, scored on a scale from 1 to 7 by using the VascuQol-25 questionnaire) on an index scale ranging from 1 (worst possible) to 7(best possible). The total number of QALYs was calculated by multiplying the HRQoL index score (QALY weight) by the time spent in each health state. One QALY can be viewed as living for 1 year in the best possible health.

  4. Survival Rate

    Time frame: 1 month; 6 months; 12 months; 24 months; 36 months

    Telephone follow-up visit and/or medical chart review and/or publicly available records consultation for vital status.

Other outcomes

  1. Clinically-driven target lesion revascularization (CD-TLR)

    Time frame: 1 month; 6 months; 12 months; 24 months; 36 months

    Any surgical or percutaneous intervention to the target lesion(s) after the index procedure.

  2. Wound healing

    Time frame: 1 month; 6 months; 12 months; 24 months; 36 months

    The wound diameter and ulcer grade.

  3. Incremental cost effectiveness ratio (ICER)

    Time frame: 1 month; 6 months; 12 months; 24 months; 36 months

    The difference in costs are divided by the difference in QALY or VascuQol.

  4. Improvement of dietary and life style

    Time frame: 1 month; 6 months; 12 months; 24 months; 36 months

    The dietary habits and lifestyle of the patients were collected by questionnaire before operation. Before discharge, patients received education on healthy diet and lifestyle, and information on diet and lifestyle was collected at follow-up.

  5. Cost effectiveness acceptability curve

    Time frame: 1 month; 6 months; 12 months; 24 months; 36 months

    It shows the probability of one treatment being more efficient in terms of QALYs than the other treatment for different levels of willingness to pay.

  6. Ankle brachial index (ABI)

    Time frame: 1 month; 6 months; 12 months; 24 months; 36 months

    The ratio of systolic pressure measured at the ankle artery to the brachial artery.

Study contacts

Contact information is provided by the study sponsor or research team.

Haoliang Wu

CONTACT

[email protected]

18738957806

Zilun Li

CONTACT

[email protected]

13760871576

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University

Other

Registry information

Official study title

Outcome and Improvement of Different Treatment in Arteriosclerosis Obliterans: a Prospective, Single-center, Observational Study

Important dates

Study start
2024
Primary completion
2026
Study completion
2029
First posted
Jul 3, 2024
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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