NCT05286710

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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.

Conditions

• Deep Vein Thrombosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-09-01
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2022-03-18
• Last updated: 2025-05-15

Locations

1 site across 1 country: China