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

Recruiting

• Conditions: Pharmacomechanical Thrombolysis; Deep Vein Thrombosis
• Interventions: Procedure: Pharmacomechanical thrombolysis

• Registration Number: NCT05356767
• Lead Sponsor: Chengdu University of Traditional Chinese Medicine

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.

Study Timeline

• Study Start: 2022-04-01
• Study First Submitted: 2022-04-27
• Study First Submitted QC: 2022-04-27
• Status Verified: 2022-05
• Study First Posted: 2022-05-02
• Last Update Submitted: 2022-05-05
• Last Update Posted: 2022-05-11
• Primary Completion: 2024-04-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
post-thromboticsyndrome	Pharmacomechanical thrombolysis	suffering from PTS (Villalta score) at 2 years after operation.
n-post-thromboticsyndrome	Pharmacomechanical thrombolysis	none of PTS (Villalta score) at 2 years after operation.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Chunshuihe; 🇨🇳 Chengdu, Sichuan, China