Deep Vein ThrombosisNCT06124768
Comparison Of Percutaneous Mechanical Thrombectomy With Different Access in Treatment of Acute Deep Venous Thrombosis
An observational study of Deep Vein Thrombosis, run by RenJi Hospital at 1 site in China.
Trial summary
The study aims to compare the modified approach through ipsilateral deep calf venous access or contralateral femoral venous access with the traditional approach through ipsilateral popliteal venous access for iliofemoral deep venous thrombosis (DVT) with distal popliteal vein thrombosis, and determine whether it can… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Deep Vein Thrombosis
- What is being tested?
- Percutaneous mechanical thrombectomy (PMT) by the modified approach, Percutaneous mechanical thrombectomy (PMT) by the traditional approach and Traditional approach
- Type of treatment
- Surgery or procedure
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age between 18-85 years old;
- Acute DVT occurred no more than 14 days since the onset of disease;
- DVT treated by percutaneous mechanical thrombectomy
- Informed consent signed by patients.
Who cannot join
- Patients who are known to be allergic to heparin, low molecular weight heparin, or contrast agent;
- Women during pregnancy and lactation;
- Patients with other diseases that may cause difficulty in the study or significantly shorten the life expectancy of patients (<6 months);
- Patients who are unable or unwilling to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Renji Hospital
Shanghai, Shanghai Municipality, 200127
Ni Qihong, M.D., +86 15801900772, niqihong1989@163.com
About this study
Official title: Comparison Of Percutaneous Mechanical Thrombectomy With Different Access in Treatment of Acute Deep Venous Thrombosis (The CODA Study)
The study aims to compare the modified approach through ipsilateral deep calf venous access or contralateral femoral venous access with the traditional approach through ipsilateral popliteal venous access for iliofemoral deep venous thrombosis (DVT) with distal popliteal vein thrombosis, and determine whether it can achieve similar therapeutic effects as iliofemoral DVT without distal popliteal vein thrombosis.
Read the 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 or contralateral femoral venous access with the traditional approach for iliofemoral DVT with distal popliteal vein thrombosis, and determine whether it can achieve similar therapeutic effects as iliofemoral DVT without distal popliteal vein thrombosis. The purpose of this study is to obtain high-level evidence for the endovascular treatment of acute DVT.
- Conditions
- Deep Vein Thrombosis
- Being tested
- Percutaneous mechanical thrombectomy (PMT) by the modified approach, Percutaneous mechanical thrombectomy (PMT) by the traditional approach, Traditional approach
- Keywords
- Deep venous thrombosis, Percutaneous mechanical thrombectomy, Post-thrombotic syndrome
- Medical subject headings
- Venous Thrombosis, Postthrombotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous mechanical thrombectomy (PMT) by the modified approachProcedure or surgery
The modified approach includes the ipsilateral calf venous access and the contralateral femoral venous access. Through contralateral femoral venous access, a hydrophilic guide wire and a catheter will be crossover through the thrombus side to the distal calf vein. The ipsilateral calf venous access will be punctured under the guidance of ascending venography. A hydrophilic guide wire and a catheter will be used to pass through the thrombus antegrade to the inferior vena cava. Percutaneous mechanical thrombectomy (PMT) catheter will be used to clear the thrombus. After PMT treatment, residual thrombus will be reevaluated by ascending venography. Catheter-directed thrombolysis (CDT) will be conducted if there is residual thrombus. Percutaneous balloon angioplasty (PTA) and stenting will be conducted if there is >50% stenosis of the diameter of the iliac vein.
Percutaneous mechanical thrombectomy (PMT) by the traditional approachProcedure or surgery
The traditional approach will be punctured from the ipsilateral popliteal vein under ultrasound guidance. A hydrophilic guide wire and a catheter will be used to pass through the thrombus antegrade to the inferior vena cava. Percutaneous mechanical thrombectomy (PMT) catheter will be used to clear the thrombus. After PMT treatment, residual thrombus will be reevaluated by ascending venography. Catheter-directed thrombolysis (CDT) will be conducted if there is residual thrombus. Percutaneous balloon angioplasty (PTA) and stenting will be conducted if there is >50% stenosis of the diameter of the iliac vein.
Traditional approachProcedure or surgery
The approach will be punctured from either the ipsilateral femoral vein or popliteal vein. A hydrophilic guide wire and a catheter will be used to pass through the thrombus antegrade to the inferior vena cava. Percutaneous mechanical thrombectomy (PMT) catheter will be used to clear the thrombus. After PMT treatment, residual thrombus will be reevaluated by ascending venography. Catheter-directed thrombolysis (CDT) will be conducted if there is residual thrombus. Percutaneous balloon angioplasty (PTA) and stenting will be conducted if there is >50% stenosis of the diameter of the iliac vein.
| Study group | Role | What they receive |
|---|---|---|
| Iliofemoral DVT with distal popliteal vein thrombosis treated by PMT through the modified access | Anterograde venography shows patients with iliofemoral DVT with distal popliteal vein thrombosis. PMT is performed via ipsilateral distal calf venous access or contralateral femoral access. Receives: Procedure: Percutaneous mechanical thrombectomy (PMT) by the modified approach | |
| Iliofemoral DVT with distal popliteal vein thrombosis treated by PMT through the traditional access | Anterograde venography shows patients with iliofemoral DVT with distal popliteal vein thrombosis. PMT is performed via ipsilateral popliteal venous access. Receives: Procedure: Percutaneous mechanical thrombectomy (PMT) by the traditional approach | |
| Iliofemoral DVT without distal popliteal vein thrombosis treated by PMT | Anterograde venography shows patients with iliofemoral DVT without distal popliteal vein thrombosis. PMT is performed via any access, such as ipsilateral femoral venous access or ipsilateral popliteal venous access. Receives: Procedure: Traditional approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of post-thrombotic syndrome
Incidence of post-thrombotic syndrome (PTS) evaluated by Villalta score
Measured: 24-month
Secondary outcomes (6)
Rate of catheter-directed thrombolysis
Percentage of catheter-directed thrombolysis after mechanical thrombectomy
Measured: Immediately after interventional surgery
Total time of interventional surgery
Total time measured by hours of interventional surgery (Including duration of subsequent catheter directed thrombolysis)
Measured: Immediately after interventional surgery
Total dosage of urokinase
Total dosage measured by units of urokinase used for procedure
Measured: Immediately after interventional surgery
Patency rate of lower limb vein
Percentage of patency rate of lower limb vein evaluated by ultrasound
Measured: 24-month
Incidence of post-thrombotic syndrome
Incidence of post-thrombotic syndrome (PTS) evaluated by Villalta score
Measured: 12-month
Re-intervention rate
Percentage of re-intervention rate for the same limb
Measured: 24-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start1 Jan 2021
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Vein ThrombosisStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- First People's Hospital of Hangzhou, Chengdu University of Traditional Chinese Medicine
- Responsible party
- Sponsor
- Investigators
- Ni Qihong, M.D., Study director, Department of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06124768
- Sponsor's protocol ID
- The CODA study
- Status last verified
- Feb 2026
- First submitted
- 6 Nov 2023
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Percutaneous Mechanical Thrombectomy With Different Access in Treatment of Acute Deep Venous Thrombosis (The CODA Study)
- ClinicalTrials.gov ID
- NCT06124768
- Acronym / sponsor ID
- The CODA study
- Conditions
- Deep Vein Thrombosis
- Keywords
- Deep venous thrombosis, Percutaneous mechanical thrombectomy, Post-thrombotic syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- First People's Hospital of Hangzhou, Chengdu University of Traditional Chinese Medicine
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 9 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to compare the modified approach through ipsilateral deep calf venous access or contralateral femoral venous access with the traditional approach through ipsilateral popliteal venous access for iliofemoral deep venous thrombosis (DVT) with distal popliteal vein thrombosis, and determine whether it can achieve similar therapeutic effects as iliofemoral DVT without distal popliteal vein thrombosis.
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 or contralateral femoral venous access with the traditional approach for iliofemoral DVT with distal popliteal vein thrombosis, and determine whether it can achieve similar therapeutic effects as iliofemoral DVT without distal popliteal vein thrombosis. The purpose of this study is to obtain high-level evidence for the endovascular treatment of acute DVT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Iliofemoral DVT with distal popliteal vein thrombosis treated by PMT through the modified access | – | Procedure: Percutaneous mechanical thrombectomy (PMT) by the modified approachAnterograde venography shows patients with iliofemoral DVT with distal popliteal vein thrombosis. PMT is performed via ipsilateral distal calf venous access or contralateral femoral access. |
| Iliofemoral DVT with distal popliteal vein thrombosis treated by PMT through the traditional access | – | Procedure: Percutaneous mechanical thrombectomy (PMT) by the traditional approachAnterograde venography shows patients with iliofemoral DVT with distal popliteal vein thrombosis. PMT is performed via ipsilateral popliteal venous access. |
| Iliofemoral DVT without distal popliteal vein thrombosis treated by PMT | – | Procedure: Traditional approachAnterograde venography shows patients with iliofemoral DVT without distal popliteal vein thrombosis. PMT is performed via any access, such as ipsilateral femoral venous access or ipsilateral popliteal venous access. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Age between 18-85 years old;
- Acute DVT occurred no more than 14 days since the onset of disease;
- DVT treated by percutaneous mechanical thrombectomy
- Informed consent signed by patients.
Key exclusion criteria (4 listed)
- Patients who are known to be allergic to heparin, low molecular weight heparin, or contrast agent;
- Women during pregnancy and lactation;
- Patients with other diseases that may cause difficulty in the study or significantly shorten the life expectancy of patients (<6 months);
- Patients who are unable or unwilling to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous mechanical thrombectomy (PMT) by the modified approachThe modified approach includes the ipsilateral calf venous access and the contralateral femoral venous access. Through contralateral femoral venous access, a hydrophilic guide wire and a catheter will be crossover through the thrombus side to the distal calf vein. The ipsilateral calf venous access will be punctured under the guidance of ascending venography. A hydrophilic guide wire and a catheter will be used to pass through the thrombus antegrade to the inferior vena cava. Percutaneous mechanical thrombectomy (PMT) catheter will be used to clear the thrombus. After PMT treatment, residual thrombus will be reevaluated by ascending venography. Catheter-directed thrombolysis (CDT) will be conducted if there is residual thrombus. Percutaneous balloon angioplasty (PTA) and stenting will be conducted if there is >50% stenosis of the diameter of the iliac vein. | Procedure or surgery | Iliofemoral DVT with distal popliteal vein thrombosis treated by PMT through the modified access |
| Percutaneous mechanical thrombectomy (PMT) by the traditional approachThe traditional approach will be punctured from the ipsilateral popliteal vein under ultrasound guidance. A hydrophilic guide wire and a catheter will be used to pass through the thrombus antegrade to the inferior vena cava. Percutaneous mechanical thrombectomy (PMT) catheter will be used to clear the thrombus. After PMT treatment, residual thrombus will be reevaluated by ascending venography. Catheter-directed thrombolysis (CDT) will be conducted if there is residual thrombus. Percutaneous balloon angioplasty (PTA) and stenting will be conducted if there is >50% stenosis of the diameter of the iliac vein. | Procedure or surgery | Iliofemoral DVT with distal popliteal vein thrombosis treated by PMT through the traditional access |
| Traditional approachThe approach will be punctured from either the ipsilateral femoral vein or popliteal vein. A hydrophilic guide wire and a catheter will be used to pass through the thrombus antegrade to the inferior vena cava. Percutaneous mechanical thrombectomy (PMT) catheter will be used to clear the thrombus. After PMT treatment, residual thrombus will be reevaluated by ascending venography. Catheter-directed thrombolysis (CDT) will be conducted if there is residual thrombus. Percutaneous balloon angioplasty (PTA) and stenting will be conducted if there is >50% stenosis of the diameter of the iliac vein. | Procedure or surgery | Iliofemoral DVT without distal popliteal vein thrombosis treated by PMT |
Primary outcome
Incidence of post-thrombotic syndrome
Time frame: 24-month
Incidence of post-thrombotic syndrome (PTS) evaluated by Villalta score
6 secondary outcomes
Rate of catheter-directed thrombolysis
Time frame: Immediately after interventional surgery
Total time of interventional surgery
Time frame: Immediately after interventional surgery
Total dosage of urokinase
Time frame: Immediately after interventional surgery
Patency rate of lower limb vein
Time frame: 24-month
Incidence of post-thrombotic syndrome
Time frame: 12-month
Re-intervention rate
Time frame: 24-month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ni Qihong, M.D. study director
Department of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deep Vein Thrombosis, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ni Qihong, M.D. (+8615801900772, niqihong1989@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of post-thrombotic syndrome (time frame: 24-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.