The Study of Percutaneous Mechanical Thrombectomy Treating Acute Deep Vein Thrombosis of Lower Extremities

the Director of Vascular Surgery of Hospital of Chengdu University of Traditional Chinese Medicine

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.

Study Overview

• Status: Recruiting
• Conditions: Deep Vein Thrombosis; Pharmacomechanical Thrombolysis
• Intervention / Treatment: Procedure: Pharmacomechanical thrombolysis

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.

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

• Study Contact: Name: Wei Huang, master; Phone Number: 028-87766214 86-18008068144; Email: 254652468@qq.com

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610000
      • Recruiting
      • Chunshuihe
      • Contact: Wei Huang, Master; Phone Number: 86-18008068144; Email: 254652468@qq.com

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Deep vein thrombosis

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
post-thromboticsyndrome; suffering from PTS (Villalta score) at 2 years after operation.	Procedure: Pharmacomechanical thrombolysis; Pharmacomechanical thrombolysis
n-post-thromboticsyndrome; none of PTS (Villalta score) at 2 years after operation.	Procedure: Pharmacomechanical thrombolysis; Pharmacomechanical thrombolysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lower extremity deep vein patency rate 6 months after operation	The patency of the lower extremity veins was assessed by lower extremity venous ultrasound or lower extremity venography.	6 months
Incidence of sequelae of deep venous thrombosis after PMT	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.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total duration of interventional treatment	Including the entire operation time of interventional surgery	1 day
Total urokinase dosage	interventional surgery urokinase dosage	1 day
Lower extremity deep venous patency rate of patients before discharge	The patency rate of lower extremity deep veins in patients 1 week after operation	1 week
Postoperative quality of life score (QOL)	Postoperative quality of life scoring using the QOL scale	6 months,12 months,18 months and 24 months
reoperation rate	Reoperation due to thrombosis, pts	6 months,12 months,18 months and 24 months
Incidence of bleeding complications	Symptoms of perioperative hemorrhage	1day，7day，3 months

Collaborators and Investigators

• Sponsor: Chengdu University of Traditional Chinese Medicine
• Investigators: Principal Investigator: Meng Ye, doctor, Study Principal Investigator RenJi Hospital; Principal Investigator: Ziheng Wu, doctor, Study Principal Investigator Zhejiang University; Principal Investigator: Lianrui Guo, doctor, Study Principal Investigator Xuanwu Hospital, Beijing; Principal Investigator: Xin Fang, doctor, Study Principal Investigator Hangzhou first people's Hospital of Medical College of Zhejiang University; Principal Investigator: Hongfei Sang, doctor, Study Principal Investigator Second Affiliated Hospital of Suzhou University; Principal Investigator: Qiang Li, doctor, Study Principal Investigator Qingdao Haici Hospital affiliated to Qingdao University; Principal Investigator: Zibo Feng, doctor, Study Principal Investigator Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology; Principal Investigator: Zhenyu Shi, doctor, Shanghai Zhongshan Hospital; Principal Investigator: Weihao Shi, doctor, Huashan Hospital; Principal Investigator: Wensheng Lou, doctor, The First Affiliated Hospital With Affiliated Nanjing Medical University; Principal Investigator: Hui Zhao, doctor, Affiliated Hospital Of Nantong University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Anticipated): April 1, 2024
• Study Completion (Anticipated): April 1, 2026

Study Registration Dates

• First Submitted: April 27, 2022
• First Submitted That Met QC Criteria: April 27, 2022
• First Posted (Actual): May 2, 2022

Study Record Updates

• Last Update Posted (Actual): May 11, 2022
• Last Update Submitted That Met QC Criteria: May 5, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Deep vein thrombosis; Pharmacomechanical thrombolysis; post-thromboticsyndrome
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis
• Other Study ID Numbers: ChengduUTCMvs3

Drug and device information, study documents

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