Clinical trial NCT06009146: Results of Endovascular Treatment for Infrapopliteal Arterial Occlusive Disease.
Official title: Results of Endovascular Treatment for Infrapopliteal Arterial Occlusive Disease: a Prospective, Multicenter, Real-world Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infrapopliteal Artery Occlusive Disease
Endovascular Treatment
Keywords: Endovascular Treatment
Infrapopliteal Artery Disease
Drug-coated Balloons
Angioplasty
Atherectomy
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
Collaborators: name: Peking University Third Hospital
name: Peking University First Hospital
name: Beijing Hospital
name: Hospital of Chengdu University of Traditional Chinese Medicine
name: The First Affiliated Hospital of Dalian Medical University
name: Huashan Hospital
name: Shanghai Pudong Hospital
name: Shanghai Zhongshan Hospital
name: The First Affiliated Hospital of Guangzhou Medical University
name: Changhai Hospital
name: Hebei General Hospital
name: Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
name: LanZhou University
name: The Second Hospital University of South China
name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: The Affiliated Hospital of Qingdao University
name: Qingdao Haici Hospital
name: Beijing Tsinghua Changgeng Hospital
name: First Hospital of Tsinghua University
name: Shanxi Provincial People's Hospital
name: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
name: RenJi Hospital
name: The Luhe Teaching Hospital of the Capital Medical University
name: Beijing Friendship Hospital
name: Second Affiliated Hospital of Soochow University
name: Tianjin First Central Hospital
name: Tianjin Medical University General Hospital
name: Renmin Hospital of Wuhan University
name: First Affiliated Hospital Xi'an Jiaotong University
name: First Affiliated Hospital of Xinjiang Medical University
name: Zhejiang University
name: The First Affiliated Hospital of Zhengzhou University
name: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Xiyuan Hospital of China Academy of Chinese Medical Sciences
name: Xiangya Hospital of Central South University
name: First Affiliated Hospital of Chongqing Medical University
First posted: 2023-08-24
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with infrapopliteal arterial occlusive disease undergoing endovascular treatment.

Brief 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.

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.

Eligibility criteria: 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；

Primary outcomes:
measure: Freedom from major adverse event rate
timeFrame: 12 months
Secondary outcomes:
measure: Amputation-free survival
timeFrame: 12 months
measure: Survival
timeFrame: 12 months
measure: Freedom from major amputation
timeFrame: 12 months
measure: Freedom from CDTLR
timeFrame: 12 months
measure: Freedom from clinical driven target limb revascularization
timeFrame: 12 months
measure: Rutherford categories
timeFrame: 12 months
measure: Wound condition
timeFrame: 12 months
measure: Complication rates
timeFrame: 1 week
measure: Quality of life score
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Lianrui Guo, M.D.
role: STUDY_CHAIR
References: