Outcome and Improvement of Different Treatment in Arteriosclerosis Obliterans

NCT06485622 | Recruiting

• 1 other identifier: [2024]225
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Arteriosclerosis Obliterans

Outcome Measures

Primary Outcomes (4)

• Limb salvage rate

  Freedom from above ankle amputation in target limb.

  1 month; 6 months; 12 months; 24 months; 36 months

• Primary patency rate

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

  1 month; 6 months; 12 months; 24 months; 36 months

• Major adverse limb event (MALE) rate

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

  1 month; 6 months; 12 months; 24 months; 36 months

• All cause mortality rate

  Death due to any cause.

  1 month; 6 months; 12 months; 24 months; 36 months

Secondary Outcomes (4)

• Restenosis of the target lesion

  1 month; 6 months; 12 months; 24 months; 36 months

• Major adverse cardiovascular events (MACE)

  1 month; 6 months; 12 months; 24 months; 36 months

• Quality-adjusted life-years (QALYs)

  1 month; 6 months; 12 months; 24 months; 36 months

• Survival Rate

  1 month; 6 months; 12 months; 24 months; 36 months

Other Outcomes (6)

• Clinically-driven target lesion revascularization (CD-TLR)

  1 month; 6 months; 12 months; 24 months; 36 months

• Wound healing

  1 month; 6 months; 12 months; 24 months; 36 months

• Incremental cost effectiveness ratio (ICER)

  1 month; 6 months; 12 months; 24 months; 36 months

Study Arms (6)

Bypass group

open bypass group

Procedure: open bypass group

BMS group

BMS (bare metal stent) group

Procedure: bare metal stent group

POBA group

POBA (plain old balloon angioplasty) group

Procedure: plain old balloon angioplasty group

DCB group

drug-coated balloon group

Procedure: drug-coated balloon group

DA group

DA (directional atherectomy) group

Procedure: directional atherectomy group

HR group

HR (hybrid repair) group

Procedure: hybrid repair group

Interventions

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.

Bypass group

bare metal stent group PROCEDURE

Bare metal stent implantation during the index procedure.

BMS group

plain old balloon angioplasty group PROCEDURE

Only plain old balloon was used during the index procedure.

POBA group

drug-coated balloon group PROCEDURE

Drug-coated balloon was used during the index procedure.

DCB group

directional atherectomy group PROCEDURE

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

DA group

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.

HR group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

lower extremity arteriosclerosis obliterans

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510030, China

RECRUITING

Related Publications (6)

• Scully RE, Arnaoutakis DJ, DeBord Smith A, Semel M, Nguyen LL. Estimated annual health care expenditures in individuals with peripheral arterial disease. J Vasc Surg. 2018 Feb;67(2):558-567. doi: 10.1016/j.jvs.2017.06.102. Epub 2017 Aug 25.

  PMID: 28847660 BACKGROUND

• Fowkes FG, Aboyans V, Fowkes FJ, McDermott MM, Sampson UK, Criqui MH. Peripheral artery disease: epidemiology and global perspectives. Nat Rev Cardiol. 2017 Mar;14(3):156-170. doi: 10.1038/nrcardio.2016.179. Epub 2016 Nov 17.

  PMID: 27853158 BACKGROUND

• Soga Y, Iida O, Takahara M, Hirano K, Suzuki K, Kawasaki D, Miyashita Y, Tsuchiya T. Two-year life expectancy in patients with critical limb ischemia. JACC Cardiovasc Interv. 2014 Dec;7(12):1444-9. doi: 10.1016/j.jcin.2014.06.018.

  PMID: 25523536 BACKGROUND

• Gupta R, Siada S, Lai S, Al-Musawi M, Malgor EA, Jacobs DL, Malgor RD. Critical appraisal of the contemporary use of atherectomy to treat femoropopliteal atherosclerotic disease. J Vasc Surg. 2022 Feb;75(2):697-708.e9. doi: 10.1016/j.jvs.2021.07.106. Epub 2021 Jul 22.

  PMID: 34303802 BACKGROUND

• Fu S, Zhao H, Shi J, Abzhanov A, Crawford K, Ohno-Machado L, Zhou J, Du Y, Kuo WP, Zhang J, Jiang M, Jin JG. Peripheral arterial occlusive disease: global gene expression analyses suggest a major role for immune and inflammatory responses. BMC Genomics. 2008 Aug 1;9:369. doi: 10.1186/1471-2164-9-369.

  PMID: 18673543 BACKGROUND

• Folkersen L, Persson J, Ekstrand J, Agardh HE, Hansson GK, Gabrielsen A, Hedin U, Paulsson-Berne G. Prediction of ischemic events on the basis of transcriptomic and genomic profiling in patients undergoing carotid endarterectomy. Mol Med. 2012 May 9;18(1):669-75. doi: 10.2119/molmed.2011.00479.

  PMID: 22371308 BACKGROUND

MeSH Terms

Conditions

Arteriosclerosis Obliterans

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Zilun Li

  First Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haoliang Wu

CONTACT

18738957806; wu18738957806@126.com

Zilun Li

CONTACT

13760871576; lizilun@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: July 3, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2029
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)