Actively Recruiting
Comparison Of Percutaneous Mechanical Thrombectomy With Different Access in Treatment of Acute Deep Venous Thrombosis (The CODA Study)
Led by RenJi Hospital · Updated on 2026-02-25
210
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
R
RenJi Hospital
Lead Sponsor
F
First People's Hospital of Hangzhou
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to compare different methods of performing percutaneous mechanical thrombectomy (PMT) for patients with acute iliofemoral deep venous thrombosis (DVT). It focuses on whether a modified approach using ipsilateral deep calf venous access or contralateral femoral venous access can achieve similar results as the traditional approach through ipsilateral popliteal venous access, especially in cases with distal popliteal vein thrombosis. The goal is to gather strong evidence to improve endovascular treatment for acute DVT and reduce post-thrombotic syndrome (PTS). The study involves three groups of patients with iliofemoral DVT: those with distal popliteal vein thrombosis treated by PMT via modified access routes (ipsilateral calf or contralateral femoral veins), those with distal popliteal vein thrombosis treated by the traditional ipsilateral popliteal venous access, and those without distal popliteal vein thrombosis treated by PMT via any access. During PMT, catheters and guide wires are used to remove the thrombus, with catheter-directed thrombolysis applied if residual clots remain, and balloon angioplasty and stenting performed if significant vein narrowing is detected. Participants will undergo imaging through venography before and after treatment to assess thrombus removal and vein patency. Researchers will monitor outcomes such as the incidence of post-thrombotic syndrome over 12 and 24 months, the success rate of thrombolysis, procedure duration, urokinase dosage, re-intervention rate, and long-term vein openness. The total follow-up period extends to 24 months to evaluate safety and effectiveness of the different PMT approaches.
CONDITIONS
Brief Title
Comparison Of Percutaneous Mechanical Thrombectomy With Different Access in Treatment of Acute Deep Venous Thrombosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 85 years old
- Acute deep venous thrombosis occurred within 14 days of disease onset
- Deep venous thrombosis treated by percutaneous mechanical thrombectomy
- Patient has signed informed consent
You will not qualify if you...
- Allergy to heparin, low molecular weight heparin, or contrast agents
- Women who are pregnant or breastfeeding
- Patients with other diseases that significantly shorten life expectancy (less than 6 months)
- Patients unable or unwilling to participate in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure with immediate post-interventional assessments
Participants undergo percutaneous mechanical thrombectomy (PMT) through different venous access approaches to remove blood clots in the deep veins. This includes the modified approach via ipsilateral calf or contralateral femoral vein, or the traditional approach via ipsilateral popliteal vein.
1 procedure visit and immediate post-procedure assessments
Duration - Up to 24 months
Participants are monitored for up to 24 months to assess the incidence of post-thrombotic syndrome, vein patency, and need for re-intervention following treatment.
Follow-up visits over 24 months
Trial Site Locations
Total: 1 location
1
Renji Hospital
Shanghai, Shanghai Municipality, China, 200127
Actively Recruiting
Research Team
N
Ni Qihong, M.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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