Comparison Of Percutaneous Mechanical Thrombectomy With Different Access in Treatment of Acute Deep Venous Thrombosis

Deep Vein Thrombosis Clinical Trial

Official title:

Comparison Of Percutaneous Mechanical Thrombectomy With Different Access in Treatment of Acute Deep Venous Thrombosis (The CODA Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06124768
• Other study ID #: The CODA study
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: October 31, 2027

Study information

• Verified date: November 2023
• Source: RenJi Hospital
• Contact: Ni Qihong, M.D.
• Phone: +8615801900772
• Email: niqihong1989[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study aims to compare the modified approach through ipsilateral deep calf venous access of contralateral femoral venous access with the traditional approach through ipsilateral popliteal venous access for mixed type deep venous thrombosis (DVT), and determine whether it can achieve similar therapeutic effects as central type DVT.

Description:

Acute deep venous thrombosis (DVT) is associated with development of post-thrombotic syndrome (PTS). Early removal of iliofemoral thrombosis by percutaneous mechanical thrombectomy (PMT) may reduce the incidence of PTS. In general, PMT is performed through ipsilateral popliteal venous access as a traditional approach. However, the thrombosis in distal popliteal vein cannot be removed. Previous study demonstrated that the residual thrombus may decrease the efficacy of PMT. The study aims to compare the modified approach through ipsilateral deep calf venous access of contralateral femoral venous access with the traditional approach for mixed type DVT, and determine whether it can achieve similar therapeutic effects as central type DVT. The purpose of this study is to obtain high-level evidence for the endovascular treatment of acute DVT.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: October 31, 2027
• Est. primary completion date: October 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Age between 18-85 years old;

2. Acute DVT occurred no more than 14 days since the onset of disease;

3. DVT treated by percutaneous mechanical thrombectomy

4. Informed consent signed by patients.

Exclusion Criteria:

1. Patients who are known to be allergic to heparin, low molecular weight heparin, or contrast agent;

2. Women during pregnancy and lactation;

3. Patients with other diseases that may cause difficulty in the study or significantly shorten the life expectancy of patients (<6 months);

4. Patients who are unable or unwilling to participate in the study.

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

Procedure:
• Percutaneous mechanical thrombectomy (PMT) by the modified approach
The modified approach includes the ipsilateral calf venous access and the contralateral femoral venous access. Through contralateral femoral venous access, a hydrophilic guide wire and a catheter will be crossover through the thrombus side to the distal calf vein. The ipsilateral calf venous access will be punctured under the guidance of ascending venography. A hydrophilic guide wire and a catheter will be used to pass through the thrombus antegrade to the inferior vena cava. Percutaneous mechanical thrombectomy (PMT) catheter will be used to clear the thrombus. After PMT treatment, residual thrombus will be reevaluated by ascending venography. Catheter-directed thrombolysis (CDT) will be conducted if there is residual thrombus. Percutaneous balloon angioplasty (PTA) and stenting will be conducted if there is >50% stenosis of the diameter of the iliac vein.
• Percutaneous mechanical thrombectomy (PMT) by the traditional approach
The traditional approach will be punctured from the ipsilateral popliteal vein under ultrasound guidance. A hydrophilic guide wire and a catheter will be used to pass through the thrombus antegrade to the inferior vena cava. Percutaneous mechanical thrombectomy (PMT) catheter will be used to clear the thrombus. After PMT treatment, residual thrombus will be reevaluated by ascending venography. Catheter-directed thrombolysis (CDT) will be conducted if there is residual thrombus. Percutaneous balloon angioplasty (PTA) and stenting will be conducted if there is >50% stenosis of the diameter of the iliac vein.

Locations

Country	Name	City	State
China	Renji Hospital	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
RenJi Hospital	Chengdu University of Traditional Chinese Medicine, First People's Hospital of Hangzhou

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immediate patency rate	Percentage of patency rate immediately after lonely percutaneous mechanical thrombectomy	Immediately after lonely percutaneous mechanical thrombectomy
Primary	Incidence of post-thrombotic syndrome	Incidence of post-thrombotic syndrome (PTS) evaluated by Villalta score	24-month
Secondary	Rate of catheter-directed thrombolysis	Percentage of catheter-directed thrombolysis after mechanical thrombectomy	Immediately after interventional surgery
Secondary	Total time of interventional surgery	Total time measured by hours of interventional surgery (Including duration of subsequent catheter directed thrombolysis)	Immediately after interventional surgery
Secondary	Total dosage of urokinase	Total dosage measured by units of urokinase used for procedure	Immediately after interventional surgery
Secondary	Patency rate of lower limb vein	Percentage of patency rate of lower limb vein evaluated by ultrasound	24-month
Secondary	Incidence of post-thrombotic syndrome	Incidence of post-thrombotic syndrome (PTS) evaluated by Villalta score	12-month
Secondary	Re-intervention rate	Percentage of re-intervention rate for the same limb	24-month