Results of Endovascular Treatment for Infrapopliteal Arterial Occlusive Disease.

Endovascular Treatment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06009146
• Other study ID #: IPOD-Real Study
• Status: Recruiting
• Start date: July 1, 2023
• Est. completion date: October 1, 2025

Study information

• Verified date: August 2023
• Source: Xuanwu Hospital, Beijing
• Contact: Lianrui Guo, M.D.
• Phone: +8613671009746
• Email: lianruiguo[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: October 1, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Endovascular Treatment

Intervention

Device:
• Endovascular treatment
Endovascular treatment for infrapopliteal arterial disease.

Locations

Country	Name	City	State
China	Xuanwu Hospital, Capital Medical University	Beijing	Beijing

Sponsors (37)

Lead Sponsor

Collaborator

Xuanwu Hospital, Beijing

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from major adverse event rate	Major adverse events include Death, major amputation rates and clinical driven target lesion revascularization (CDTLR).	12 months
Secondary	Amputation-free survival	Freedom from death and major amputation	12 months
Secondary	Survival	Freedom from all-cause mortality.	12 months
Secondary	Freedom from major amputation	Freedom from major amputation	12 months
Secondary	Freedom from CDTLR	Freedom from clinical driven target lesion revascularization	12 months
Secondary	Freedom from clinical driven target limb revascularization	Freedom from clinical driven target limb revascularization	12 months
Secondary	Rutherford categories	Rutherford categories	12 months
Secondary	Wound condition	Wound and foot infections were scored using WIfI system.	12 months
Secondary	Complication rates	Minor and Major complications rates.	1 week
Secondary	Quality of life score	Vascular quality of life questionnaire was used.	12 months