Comparing different access methods for treating acute deep vein thrombosis

Comparison Of Percutaneous Mechanical Thrombectomy With Different Access in Treatment of Acute Deep Venous Thrombosis (The CODA Study)

This study is testing two different ways to access veins for treating acute deep vein thrombosis to see if they can improve outcomes compared to the usual method.

Quick facts

• Study type: Observational
• Enrollment: 210 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: RenJi Hospital (other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06124768 on ClinicalTrials.gov

What this trial studies

This study compares two approaches for percutaneous mechanical thrombectomy (PMT) in patients with acute deep vein thrombosis (DVT). One approach uses ipsilateral deep calf venous access while the other uses contralateral femoral venous access, both aiming to improve treatment outcomes compared to the traditional ipsilateral popliteal venous access. The goal is to determine if the modified approaches can achieve similar therapeutic effects as those seen in central type DVT. The study seeks to provide high-level evidence for the endovascular treatment of acute DVT and its potential to reduce post-thrombotic syndrome incidence.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-85 who have experienced acute DVT within the last 14 days and are eligible for percutaneous mechanical thrombectomy.

Not a fit: Patients who are allergic to heparin or contrast agents, pregnant or lactating women, and those with life-limiting conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for patients with acute deep vein thrombosis, potentially reducing the risk of post-thrombotic syndrome.

How similar studies have performed: While this approach is innovative, previous studies have indicated that addressing residual thrombus can enhance the efficacy of PMT, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

1. Age between 18-85 years old;
2. Acute DVT occurred no more than 14 days since the onset of disease;
3. DVT treated by percutaneous mechanical thrombectomy
4. Informed consent signed by patients.

Exclusion Criteria:

1. Patients who are known to be allergic to heparin, low molecular weight heparin, or contrast agent;
2. Women during pregnancy and lactation;
3. Patients with other diseases that may cause difficulty in the study or significantly shorten the life expectancy of patients (\<6 months);
4. 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, Deep venous thrombosis, Percutaneous mechanical thrombectomy, Post-thrombotic syndrome