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NCT Number: NCT06124768

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

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.

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Key information

Conditions

Deep Vein Thrombosis Cardiovascular Diseases Embolism and Thrombosis Postthrombotic Syndrome Thrombosis Vascular Diseases Venous Insufficiency Venous Thrombosis

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

Location status: Recruiting

Location contact

Ni Qihong, M.D.

CONTACT

[email protected]

+86 15801900772

About this study

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 or contralateral femoral venous access with the traditional approach for iliofemoral DVT with distal popliteal vein thrombosis, and determine whether it can achieve similar therapeutic effects as iliofemoral DVT without distal popliteal vein thrombosis. The purpose of this study is to obtain high-level evidence for the endovascular treatment of acute DVT.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Incidence of post-thrombotic syndrome

    Time frame: 24-month

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

Secondary outcomes

  1. Rate of catheter-directed thrombolysis

    Time frame: Immediately after interventional surgery

    Percentage of catheter-directed thrombolysis after mechanical thrombectomy

  2. Total time of interventional surgery

    Time frame: Immediately after interventional surgery

    Total time measured by hours of interventional surgery (Including duration of subsequent catheter directed thrombolysis)

  3. Total dosage of urokinase

    Time frame: Immediately after interventional surgery

    Total dosage measured by units of urokinase used for procedure

  4. Patency rate of lower limb vein

    Time frame: 24-month

    Percentage of patency rate of lower limb vein evaluated by ultrasound

  5. Incidence of post-thrombotic syndrome

    Time frame: 12-month

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

  6. Re-intervention rate

    Time frame: 24-month

    Percentage of re-intervention rate for the same limb

Other outcomes

  1. Major bleeding rate

    Time frame: 24 months

    Major bleeding defined by International Society on Thrombosis and Haemostasis (ISTH)

  2. Venous thromboembolism recurrence rate

    Time frame: 24 months

    Symptomatic venous thromboembolism recurrence including deep venous thrombosis and pulmonary embolism

  3. All-cause death rate

    Time frame: 24 months

    All-cause death during the follow-up period

Study contacts

Contact information is provided by the study sponsor or research team.

Ni Qihong, M.D.

CONTACT

[email protected]

+8615801900772

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Collaborators

  • Chengdu University of Traditional Chinese Medicine
  • First People's Hospital of Hangzhou

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Nov 9, 2023
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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