Clinical trial NCT06124768: Comparison Of Percutaneous Mechanical Thrombectomy With Different Access in Treatment of Acute Deep Venous Thrombosis
Official title: Comparison Of Percutaneous Mechanical Thrombectomy With Different Access in Treatment of Acute Deep Venous Thrombosis (The CODA Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Deep Vein Thrombosis
Keywords: Deep venous thrombosis
Percutaneous mechanical thrombectomy
Post-thrombotic syndrome
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: First People's Hospital of Hangzhou
name: Chengdu University of Traditional Chinese Medicine
First posted: 2023-11-09
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute lower limb deep venous thrombosis (DVT) treated by percutaneous mechanical thrombectomy (PMT). The symptoms of DVT should no more than 14 days.

Brief summary: The study aims to compare the modified approach through ipsilateral deep calf venous access of contralateral femoral venous access with the traditional approach through ipsilateral popliteal venous access for mixed type deep venous thrombosis (DVT), and determine whether it can achieve similar therapeutic effects as central type DVT.

Detailed description: Acute deep venous thrombosis (DVT) is associated with development of post-thrombotic syndrome (PTS). Early removal of iliofemoral thrombosis by percutaneous mechanical thrombectomy (PMT) may reduce the incidence of PTS. In general, PMT is performed through ipsilateral popliteal venous access as a traditional approach. However, the thrombosis in distal popliteal vein cannot be removed. Previous study demonstrated that the residual thrombus may decrease the efficacy of PMT. The study aims to compare the modified approach through ipsilateral deep calf venous access of contralateral femoral venous access with the traditional approach for mixed type DVT, and determine whether it can achieve similar therapeutic effects as central type DVT. The purpose of this study is to obtain high-level evidence for the endovascular treatment of acute DVT.

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.

Primary outcomes:
measure: Immediate patency rate
timeFrame: Immediately after lonely percutaneous mechanical thrombectomy
measure: Incidence of post-thrombotic syndrome
timeFrame: 24-month
Secondary outcomes:
measure: Rate of catheter-directed thrombolysis
timeFrame: Immediately after interventional surgery
measure: Total time of interventional surgery
timeFrame: Immediately after interventional surgery
measure: Total dosage of urokinase
timeFrame: Immediately after interventional surgery
measure: Patency rate of lower limb vein
timeFrame: 24-month
measure: Incidence of post-thrombotic syndrome
timeFrame: 12-month
measure: Re-intervention rate
timeFrame: 24-month
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital
state: Shanghai
Study officials:
affiliation: Department of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University
name: Ni Qihong, M.D.
role: STUDY_DIRECTOR
References: