Results of Endovascular Treatment for Infrapopliteal Arterial Occlusive Disease.

Results of Endovascular Treatment for Infrapopliteal Arterial Occlusive Disease: a Prospective, Multicenter, Real-world Study

This study is a prospective, multi-center observational study, which evaluates the effectiveness and safety of endovascular therapy in the real world for infrapopliteal arterial occlusive disease from intermittent claudication to chronic threatening limb ischemia.

Study Overview

• Status: Recruiting
• Conditions: Endovascular Treatment; Infrapopliteal Artery Occlusive Disease
• Intervention / Treatment: Device: Endovascular treatment

Detailed Description

This study is a prospective, multi-center observational study. This study will be conducted at 38 centers and is expected to enroll more than 3000 patients. And we will evaluate the effectiveness and safety of endovascular therapy in the real world for infrapopliteal arterial occlusive disease from intermittent claudication to chronic threatening limb ischemia.

• Study Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Lianrui Guo, M.D.; Phone Number: +8613671009746; Email: lianruiguo@sina.com
• Study Contact Backup: Name: Xixiang Gao, M.D.; Phone Number: +8613581674309; Email: vascsurgeon@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Recruiting
      • Xuanwu Hospital, Capital Medical University
      • Contact: Xixiang Gao, M.D.; Phone Number: +8613581674309; Email: vascsurgeon@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with infrapopliteal arterial occlusive disease undergoing endovascular treatment.

Description

Inclusion Criteria:

Patients ≥ 18 years of age; Patients with ≥1 infrapopliteal artery disease (P3 popliteal artery, anterior tibial artery, posterior tibial artery, peroneal artery, tibiofibular trunk) need to receive endovascular treatment, regardless of whether there is a combination of supra-knee or submalleolar occlusion; Patients voluntary and capable of follow-up;

Exclusion Criteria:

Patients who are known to be allergic to heparin, aspirin, other antiplatelet drugs, contrast agents, etc., and those who are unable to undergo endovascular therapy for other reasons; Pregnant and lactating women; Patients with thromboangiitis obliterans；

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Rutherford scale < 4	Device: Endovascular treatment; Endovascular treatment for infrapopliteal arterial disease.
Rutherford scale 4-5	Device: Endovascular treatment; Endovascular treatment for infrapopliteal arterial disease.
Rutherford scale 6	Device: Endovascular treatment; Endovascular treatment for infrapopliteal arterial disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from major adverse event rate	Major adverse events include Death, major amputation rates and clinical driven target lesion revascularization (CDTLR).	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amputation-free survival	Freedom from death and major amputation	12 months
Survival	Freedom from all-cause mortality.	12 months
Freedom from major amputation	Freedom from major amputation	12 months
Freedom from CDTLR	Freedom from clinical driven target lesion revascularization	12 months
Freedom from clinical driven target limb revascularization	Freedom from clinical driven target limb revascularization	12 months
Rutherford categories	Rutherford categories	12 months
Wound condition	Wound and foot infections were scored using WIfI system.	12 months
Complication rates	Minor and Major complications rates.	1 week
Quality of life score	Vascular quality of life questionnaire was used.	12 months

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing
• Collaborators: Peking University First Hospital; Changhai Hospital; Xiangya Hospital of Central South University; LanZhou University; Beijing Friendship Hospital; Shanghai Zhongshan Hospital; Peking University Third Hospital; RenJi Hospital; Huashan Hospital; Hebei General Hospital; First Affiliated Hospital Xi'an Jiaotong University; The Affiliated Hospital of Qingdao University; The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; Beijing Hospital; The First Affiliated Hospital of Zhengzhou University; Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University; The First Affiliated Hospital of Guangzhou Medical University; Xiyuan Hospital of China Academy of Chinese Medical Sciences; Tianjin Medical University General Hospital; Renmin Hospital of Wuhan University; Zhejiang University; Chinese Academy of Medical Sciences, Fuwai Hospital; Second Affiliated Hospital of Soochow University; Tianjin First Central Hospital; The Luhe Teaching Hospital of the Capital Medical University; First Affiliated Hospital of Xinjiang Medical University; First Affiliated Hospital of Chongqing Medical University; The First Affiliated Hospital of Dalian Medical University; Shanghai Pudong Hospital; Qingdao Haici Hospital; Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology; Beijing Tsinghua Changgeng Hospital; First Hospital of Tsinghua University; Shanxi Provincial People's Hospital; Hospital of Chengdu University of Traditional Chinese Medicine; The Second Hospital University of South China
• Investigators: Study Chair: Lianrui Guo, M.D., Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: August 20, 2023
• First Submitted That Met QC Criteria: August 20, 2023
• First Posted (Actual): August 24, 2023

Study Record Updates

• Last Update Posted (Actual): August 24, 2023
• Last Update Submitted That Met QC Criteria: August 20, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Angioplasty; Atherectomy; Endovascular Treatment; Drug-coated Balloons; Infrapopliteal Artery Disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases
• Other Study ID Numbers: IPOD-Real Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No