RecruitingNot ApplicableNCT05286710

Rheolytic Thrombectomy For Acute Deep Vein Thrombosis Of Whole Lower Limb

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


Sponsor

RenJi Hospital

Enrollment

160 participants

Start Date

Sep 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

  • 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 Criteria10

  • 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.

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Interventions

DEVICEpharmacomechanical thrombectomy (PMT)

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.


Locations(1)

Renji Hospital

Shanghai, Shanghai Municipality, China

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NCT05286710


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