Rheolytic Thrombectomy For Acute Deep Vein Thrombosis Of Whole Lower Limb

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).

Conditions

• Deep Vein Thrombosis

Interventions

DEVICE

pharmacomechanical 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.

Sponsors & Collaborators

• First People's Hospital of Hangzhou

  collaborator OTHER

• The First Affiliated Hospital with Nanjing Medical University

  collaborator OTHER

• Affiliated Hospital of Nantong University

  collaborator OTHER

• Chengdu University of Traditional Chinese Medicine

  collaborator OTHER

• Second Affiliated Hospital of Suzhou University

  collaborator OTHER

• Liuzhou Workers' Hospital

  collaborator OTHER_GOV

• Shanghai Pudong New Area People's Hospital

  collaborator OTHER

• Zhejiang University

  collaborator OTHER

• RenJi Hospital

  lead OTHER

Principal Investigators

• Meng Ye, M.D. · Department of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-09-01

Primary Completion

2026-12-31

Completion

2027-12-31

Countries

• China

Study Locations