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NCT Number: NCT05286710

Rheolytic Thrombectomy For Acute Deep Vein Thrombosis Of Whole Lower Limb

Ipsilateral popliteal venous the most common access for pharmacomechanical thrombectomy (PMT) in the treatment of acute deep venous thrombosis (DVT), but the result was not satisfactory. The investigators adjust the access to improve the thrombus clearance rate and reduce the incidence of post-thrombotic syndrome (PTS).

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

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) with whole lower limb involved is associated with significant post thrombotic morbidity. Both of deep venous occlusion and valvar reflux increase the risk for development of post-thrombotic syndrome (PTS). Early removal of iliofemoral thrombosis by pharmacomechanical thrombectomy (PMT) may reduce the incidence of PTS. In general, ipsilateral popliteal venous the most common access for PMT. However, from this approach, it's hard to remove the thrombosis in the distal popliteal vein. So, the investigators hypothesize that the residual thrombus and slow blood-flow in the in-flow may weakened the efficacy of PMT, and by adjusting vein access approach could improve the thrombus clearance rate and reduce the incidence of PTS for whole leg DVT.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age between 18-80 years old;
  • Acute DVT with clinical symptoms occurred less than 14 days since the onset of disease;
  • DVT with thrombosis involving the iliac vein, common femoral vein, distal popliteal vein, and/or calf vein;
  • Informed consent signed by patients.

Exclusion criteria

  • Patients with the previous history of the same side of lower-limb DVT;
  • Patients with plasma Creatinine level greater than 180umol/L;
  • Patients who are contraindicated to thrombolysis;
  • Patients with inferior vena cava thrombosis;
  • Patients who are known to be allergic to heparin, low molecular weight heparin, or contrast agent;
  • Patients who have participated in a clinical trial in the past three months;
  • Women during pregnancy and lactation
  • Patients with other diseases that may cause difficulty in the study or significantly shorten the life expectancy of patients (<2 years);
  • Patients with autoimmune thrombopathy or thrombocytopenia (platelets < 80·10⁹/L);
  • Patients who are unable or unwilling to participate in the study.

Treatment and study plan

pharmacomechanical thrombectomy (PMT)

Device

After randomization patients will be allocated to pharmacomechanical thrombectomy (PMT) via ipsilateral popliteal venous approach or to PMT via distal calf venous approach, bail-out contralateral femoral access can be used if puncture was failed in calf vein. After PMT treatment, residual thrombus was reevaluated by ascending venography. Catheter-directed thrombolysis (CDT) was conducted if there was residual thrombus. Stenosis of iliac vein was assessed by multiangle venography and intravascular ultrasound (IVUS) was used if necessary. Percutaneous balloon angioplasty (PTA) was conducted if there was >50% stenosis of the diameter of the iliac vein. A stent was placed if the residual stenosis was >50% after PTA treatment.

Primary outcomes

  1. Incidence of post-thrombotic syndrome (PTS)

    Time frame: 24 months

    Incidence of post-thrombotic syndrome (PTS) at post-interventional 24 months

Secondary outcomes

  1. Immediate patency rate

    Time frame: immediately after lonely mechanical thrombectomy

    Percentage of patency rate immediately after lonely 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: post-interventional 12 and 24 months

    Percentage of patency rate of lower limb vein at post-interventional 12 and 24 months

  5. Deep venous valve function evaluation

    Time frame: post-interventional 12 and 24 months

    Deep venous valve function evaluation by ultrasound at post-interventional 12 and 24 months

  6. Quality of life evaluated by 36-Item Short Form Health Survey (SF-36)

    Time frame: post-interventional 3, 6, 12 and 24 months

    Quality of life evaluated by 36-Item Short Form Health Survey (SF-36). The change in SF-36 Physical and Mental Component Scales from baseline to 24 months will be compared between the two groups using a t-test. A difference of 5 points on each scale is considered to be clinically relevant. In addition, a linear mixed model analysis of the repeated assessments (3, 6, 12, and 24 months) with baseline scores as a covariate will be used to investigate the changes over time, and if they differ by treatment arm.

  7. Venous Insufficiency Epidemiological and Economic Study Quality of Life (VEINES-QOL) score

    Time frame: post-interventional 3, 6, 12 and 24 months

    Venous Insufficiency Epidemiological and Economic Study Quality of Life (VEINES-QOL) score at post-interventional 24 months; The minimum value is 21, and the maximum value is 118. The higher scores mean a better outcome.

  8. European quality of life 5-dimension 5-level (EQ-5D-5L) score

    Time frame: post-interventional 3, 6, 12 and 24 months

    The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

  9. Re-intervention rate

    Time frame: within 24 months after operation

    Percentage of re-intervention rate within 24 months after operation

  10. Rate of catheter-directed thrombolysis

    Time frame: immediately after interventional surgery

    Percentage of catheter-directed thrombolysis after mechanical thrombectomy

Other outcomes

  1. Safety outcomes - procedural complications

    Time frame: Within 30 days after intervention

    Procedural complications such as hematoma at the puncture site, hemoglobinuria or hemolytic jaundice

  2. Safety outcomes - major bleeding events

    Time frame: Within 24 months after intervention

    Major bleeding events according to the International Society on Thrombosis and Haemostasis (ISTH)

  3. all-cause death

    Time frame: Within 24 months after intervention

    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

  • Affiliated Hospital of Nantong University
  • Chengdu University of Traditional Chinese Medicine
  • First People's Hospital of Hangzhou
  • Liuzhou Workers' Hospital
  • Second Affiliated Hospital of Suzhou University
  • Shanghai Pudong New Area People's Hospital
  • The First Affiliated Hospital with Nanjing Medical University
  • Zhejiang University

Registry information

Official study title

Clinical Study On The Improvement Of Rheolytic Thrombectomy For Acute Deep Vein Thrombosis Of Whole Lower Limb By Primary Popliteal Vein Thrombosis Clearance

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Mar 18, 2022
Registry last updated
May 15, 2025

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

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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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