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

Deep Vein Thrombosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05356767
• Other study ID #: ChengduUTCMvs3
• Status: Recruiting
• Start date: April 1, 2022
• Est. completion date: April 1, 2026

Study information

• Verified date: May 2022
• Source: Chengdu University of Traditional Chinese Medicine
• Contact: Chunshui He, doctor
• Phone: 86-18981885601
• Email: chunshuihe[@]msn.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: April 1, 2026
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

Procedure:
• Pharmacomechanical thrombolysis
Pharmacomechanical thrombolysis

Locations

Country	Name	City	State
China	Chunshuihe	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Chengdu University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Total duration of interventional treatment	Including the entire operation time of interventional surgery	1 day
Secondary	Total urokinase dosage	interventional surgery urokinase dosage	1 day
Secondary	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
Secondary	Postoperative quality of life score (QOL)	Postoperative quality of life scoring using the QOL scale	6 months,12 months,18 months and 24 months
Secondary	reoperation rate	Reoperation due to thrombosis, pts	6 months,12 months,18 months and 24 months
Secondary	Incidence of bleeding complications	Symptoms of perioperative hemorrhage	1day,7day,3 months