Improving treatment for acute deep vein thrombosis in the 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

This study is testing a new way to treat acute deep vein thrombosis in the entire leg to see if changing the procedure can help patients feel better and avoid long-term complications.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: RenJi Hospital (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT05286710 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates a new approach to pharmacomechanical thrombectomy (PMT) for patients with acute deep vein thrombosis (DVT) affecting the entire lower limb. The study aims to adjust the access point for the procedure to enhance thrombus clearance and reduce the risk of post-thrombotic syndrome (PTS). By targeting the iliac vein and other key areas, the researchers hope to improve outcomes for patients who have experienced DVT symptoms for less than 14 days. The trial will include patients aged 18-80 who meet specific inclusion criteria and will exclude those with certain medical conditions or previous DVT history.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 with acute DVT symptoms that began within the last 14 days.

Not a fit: Patients with a history of DVT in the same leg, contraindications to thrombolysis, or significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the incidence of post-thrombotic syndrome in patients with acute DVT.

How similar studies have performed: While similar approaches have been explored, this specific method of adjusting access for PMT in whole lower limb DVT is novel and has not been extensively tested.

Eligibility criteria

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Renji Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Ni Qihong, M.D.

Conditions Deep Vein Thrombosis; pharmacomechanical thrombectomy