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

Chengdu University of Traditional Chinese Medicine

Status: Enrolling

Conditions: Pharmacomechanical Thrombolysis; Deep Vein Thrombosis

Treatments: Procedure: Pharmacomechanical thrombolysis

Study type: Observational

Funder types: Other

Identifiers

NCT05356767

ChengduUTCMvs3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

600 participants in 2 patient groups

post-thromboticsyndrome

Description:

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

Treatment:

Procedure: Pharmacomechanical thrombolysis

n-post-thromboticsyndrome

Description:

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

Treatment:

Procedure: Pharmacomechanical thrombolysis