Clinical trial NCT05356767: The Study of Percutaneous Mechanical Thrombectomy Treating Acute Deep Vein Thrombosis of Lower Extremities
Official title: the Director of Vascular Surgery of Hospital of Chengdu University of Traditional Chinese Medicine
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pharmacomechanical Thrombolysis
Deep Vein Thrombosis
Keywords: Pharmacomechanical thrombolysis
Deep vein thrombosis
post-thromboticsyndrome
Lead sponsor: Chengdu University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2022-05-02
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Deep vein thrombosis

Brief summary: This study is a prospective, multicenter, real world, observational study intended to understand tmechanical thrombectomy in the treatment of acute deep venous thrombosis of lower extremities, It is estimated that 600 patients with DVT were enrolled in the group at 24 centers nationwide from May 2022 to May2024. we can obtain data on the incidence of sequelae of deep venous thrombosis after PMT, and analyze the factors that may affect the efficacy of PMT.

Detailed description: Through inclusion and exclusion criteria, 600 patients were collected. This experiment was an observational study case series, and no control group was established. The patency of the lower extremity veins was assessed by lower extremity venous ultrasound or lower extremity venography. According to the postoperative symptoms and signs of the patients, the Villata score, (VEINS QoL)/Sym questionnaire and VCSS score were used to understand the PTS situation.Postoperative clinical follow-up was performed at 6 months, 12 months, 18 months, and 24 months. The main endpoints were the patency rate of lower extremity deep veins at 6 months after operation and the incidence of PTS (Villalta score) at 2 years after operation.

Eligibility criteria: Inclusion Criteria:

1. The symptoms of deep venous thrombosis of lower extremities occurred within 14 days (including 14 days)；
2. Lower extremity deep venous thrombosis involving iliac vein or / and femoral vein ;
3. Obtain the informed consent of all patients.

Exclusion Criteria:

1. Patients with a previous history of ipsilateral proximal lower limb deep venous thrombosis ;
2. patients who are prohibited from thrombolytic therapy;
3. inferior vena cava compression syndrome；
4. Allergic to heparin, low molecular weight heparin or contrast medium;
5. Patients who have participated in clinical trials of other drugs or medical devices that interfere with this clinical trial in the past 3 months;
6. Patients who do not want to participate in this trial;
7. Patients with poor compliance, or those who the researchers think are not suitable for selection.

Primary outcomes:
measure: Lower extremity deep vein patency rate 6 months after operation
timeFrame: 6 months
measure: Incidence of sequelae of deep venous thrombosis after PMT
timeFrame: 24 months
Secondary outcomes:
measure: Total duration of interventional treatment
timeFrame: 1 day
measure: Total urokinase dosage
timeFrame: 1 day
measure: Lower extremity deep venous patency rate of patients before discharge
timeFrame: 1 week
measure: Postoperative quality of life score (QOL)
timeFrame: 6 months,12 months,18 months and 24 months
measure: reoperation rate
timeFrame: 6 months,12 months,18 months and 24 months
measure: Incidence of bleeding complications
timeFrame: 1day，7day，3 months
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Chunshuihe
state: Sichuan
Study officials:
affiliation: Study Principal Investigator RenJi Hospital
name: Meng Ye, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Study Principal Investigator Zhejiang University
name: Ziheng Wu, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Study Principal Investigator Xuanwu Hospital, Beijing
name: Lianrui Guo, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Study Principal Investigator Hangzhou first people's Hospital of Medical College of Zhejiang University
name: Xin Fang, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Study Principal Investigator Second Affiliated Hospital of Suzhou University
name: Hongfei Sang, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Study Principal Investigator Qingdao Haici Hospital affiliated to Qingdao University
name: Qiang Li, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Study Principal Investigator Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
name: Zibo Feng, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Zhongshan Hospital
name: Zhenyu Shi, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Huashan Hospital
name: Weihao Shi, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital With Affiliated Nanjing Medical University
name: Wensheng Lou, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Affiliated Hospital of Nantong University
name: Hui Zhao, doctor
role: PRINCIPAL_INVESTIGATOR
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