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

NCT ID: NCT05356767

Last Updated: 2022-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-01

Study Completion Date

2026-04-01

Brief Summary

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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

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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.

Conditions

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Pharmacomechanical Thrombolysis Deep Vein Thrombosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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post-thromboticsyndrome

suffering from PTS (Villalta score) at 2 years after operation.

Pharmacomechanical thrombolysis

Intervention Type PROCEDURE

Pharmacomechanical thrombolysis

n-post-thromboticsyndrome

none of PTS (Villalta score) at 2 years after operation.

Pharmacomechanical thrombolysis

Intervention Type PROCEDURE

Pharmacomechanical thrombolysis

Interventions

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Pharmacomechanical thrombolysis

Pharmacomechanical thrombolysis

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chengdu University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Chunshui He

the director of the vascular surgery of Hospital of Chengdu University of Traditional Chinese Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Meng Ye, doctor

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator RenJi Hospital

Ziheng Wu, doctor

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator Zhejiang University

Lianrui Guo, doctor

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator Xuanwu Hospital, Beijing

Xin Fang, doctor

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator Hangzhou first people's Hospital of Medical College of Zhejiang University

Hongfei Sang, doctor

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator Second Affiliated Hospital of Suzhou University

Qiang Li, doctor

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator Qingdao Haici Hospital affiliated to Qingdao University

Zibo Feng, doctor

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology

Zhenyu Shi, doctor

Role: PRINCIPAL_INVESTIGATOR

Shanghai Zhongshan Hospital

Weihao Shi, doctor

Role: PRINCIPAL_INVESTIGATOR

Huashan Hospital

Wensheng Lou, doctor

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital With Affiliated Nanjing Medical University

Hui Zhao, doctor

Role: PRINCIPAL_INVESTIGATOR

Affiliated Hospital of Nantong University

Locations

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Chunshuihe

Chengdu, Sichuan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chunshui He, doctor

Role: CONTACT

86-18981885601 ext. 028-87766214

Wei Huang, master

Role: CONTACT

86-18008068144 ext. 028-87766214

Facility Contacts

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Chunshui He, Doctor

Role: primary

86-18981885601

Wei Huang, Master

Role: backup

86-18008068144

Other Identifiers

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ChengduUTCMvs3

Identifier Type: -

Identifier Source: org_study_id

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