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

NCT06124768 | Recruiting DMC

• 1 other identifier: The CODA study
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to compare the modified approach through ipsilateral deep calf venous access or contralateral femoral venous access with the traditional approach through ipsilateral popliteal venous access for iliofemoral deep venous thrombosis (DVT) with distal popliteal vein thrombosis, and determine whether it can achieve similar therapeutic effects as iliofemoral DVT without distal popliteal vein thrombosis.

Conditions

Deep Vein Thrombosis

Keywords

Deep venous thrombosis; Percutaneous mechanical thrombectomy; Post-thrombotic syndrome

Outcome Measures

Primary Outcomes (1)

• Incidence of post-thrombotic syndrome

  Incidence of post-thrombotic syndrome (PTS) evaluated by Villalta score

  24-month

Secondary Outcomes (6)

• Rate of catheter-directed thrombolysis

  Immediately after interventional surgery

• Total time of interventional surgery

  Immediately after interventional surgery

• Total dosage of urokinase

  Immediately after interventional surgery

• Patency rate of lower limb vein

  24-month

• Incidence of post-thrombotic syndrome

  12-month

Other Outcomes (3)

• Major bleeding rate

  24 months

• Venous thromboembolism recurrence rate

  24 months

• All-cause death rate

  24 months

Study Arms (3)

Iliofemoral DVT with distal popliteal vein thrombosis treated by PMT through the modified access

Anterograde venography shows patients with iliofemoral DVT with distal popliteal vein thrombosis. PMT is performed via ipsilateral distal calf venous access or contralateral femoral access.

Procedure: Percutaneous mechanical thrombectomy (PMT) by the modified approach

Iliofemoral DVT with distal popliteal vein thrombosis treated by PMT through the traditional access

Anterograde venography shows patients with iliofemoral DVT with distal popliteal vein thrombosis. PMT is performed via ipsilateral popliteal venous access.

Procedure: Percutaneous mechanical thrombectomy (PMT) by the traditional approach

Iliofemoral DVT without distal popliteal vein thrombosis treated by PMT

Anterograde venography shows patients with iliofemoral DVT without distal popliteal vein thrombosis. PMT is performed via any access, such as ipsilateral femoral venous access or ipsilateral popliteal venous access.

Procedure: Traditional approach

Interventions

Traditional approach PROCEDURE

The approach will be punctured from either the ipsilateral femoral vein or popliteal vein. 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.

Iliofemoral DVT without distal popliteal vein thrombosis treated by PMT

Percutaneous mechanical thrombectomy (PMT) by the modified approach PROCEDURE

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.

Iliofemoral DVT with distal popliteal vein thrombosis treated by PMT through the modified access

Percutaneous mechanical thrombectomy (PMT) by the traditional approach PROCEDURE

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.

Iliofemoral DVT with distal popliteal vein thrombosis treated by PMT through the traditional access

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with acute lower limb deep venous thrombosis (DVT) treated by percutaneous mechanical thrombectomy (PMT). The symptoms of DVT should no more than 14 days.

You may qualify if:

• Age between 18-85 years old;
• Acute DVT occurred no more than 14 days since the onset of disease;
• DVT treated by percutaneous mechanical thrombectomy
• Informed consent signed by patients.

You may not qualify if:

• Patients who are known to be allergic to heparin, low molecular weight heparin, or contrast agent;
• Women during pregnancy and lactation;
• Patients with other diseases that may cause difficulty in the study or significantly shorten the life expectancy of patients (\<6 months);
• Patients who are unable or unwilling to participate in the study.

Sponsors & Collaborators

• RenJi Hospital: lead
• First People's Hospital of Hangzhou: collaborator
• Chengdu University of Traditional Chinese Medicine: collaborator

Study Sites (1)

Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

MeSH Terms

Conditions

Venous Thrombosis; Postthrombotic Syndrome

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Venous Insufficiency

Study Officials

• Ni Qihong, M.D.

  Department of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University

  STUDY DIRECTOR

Central Study Contacts

Ni Qihong, M.D.

CONTACT

+8615801900772; niqihong1989@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: November 9, 2023
• Study Start: January 1, 2021
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2027
• Last Updated: February 25, 2026

Record last verified: 2026-02

Locations

CN (1)