Cancer Patients With Acute Lower Limb Deep Vein Thrombosis (DVT)NCT06085495
Mechanical Thrombectomy for Acute Lower Limb Deep Vein Thrombosis in Tumor Patients
A study testing mechanical thrombectomy (PMT) in people with Cancer Patients With Acute Lower Limb Deep Vein Thrombosis (DVT), run by RenJi Hospital at 1 site in China.
Trial summary
This study will conduct a prospective single blind controlled study on the clinical efficacy and safety indicators of 50 cancer patients with acute lower limb deep vein thrombosis (DVT). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cancer Patients With Acute Lower Limb Deep Vein Thrombosis (DVT)
- What is being tested?
- mechanical thrombectomy (PMT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 23 Jan 2023to 15 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Between the ages of 18 and 75; 2) Suffering from acute lower limb deep vein thrombosis (DVT) with a duration of less than 14 days from onset; 3) Thrombosis involving the iliac vein, femoral vein, or popliteal vein; 4) The patient has been diagnosed with tumors, including benign or malignant tumors, including surgical or conservative treatment; 5) Sign an informed consent form.
Who cannot join
- 1) Patients with a history of deep vein thrombosis of the same lower limb in the past; 2) Patients with plasma Cr levels greater than 180umol/L; 3) Patients with contraindications to thrombolytic drugs; 4) Patients with concomitant inferior vena cava thrombosis or simple calf intermuscular vein thrombosis; 5) Patients who are known to be allergic to heparin, low molecular weight heparin, contrast agents, etc; 6) Patients who have participated in clinical trials of drugs or other medical devices that interfere with this clinical trial within the past 3 months; 7) Pregnant and lactating women; 8) Patients with a life expectancy of less than 6 months, or those with other diseases that may cause difficulty in testing or significantly shorten the patient's life expectancy (<1 year), including severe liver disease, cardiac insufficiency, etc; 9) Patients with autoimmune thrombotic disease; 10) Patients who are unable or unwilling to participate in this trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Comparative Study of Mechanical Thrombectomy and Simple Anticoagulation Therapy for Acute Lower Limb Deep Vein Thrombosis in Tumor Patients Under VTE Prevention and Control System
This study will conduct a prospective single blind controlled study on the clinical efficacy and safety indicators of 50 cancer patients with acute lower limb deep vein thrombosis (DVT). The patients were randomly divided into an experimental group (improved mechanical thrombectomy (PMT) group) and a control group (traditional simple anticoagulation group) using the "envelope method", with 25 cases each. After the end of treatment, clinical prognosis evaluations were conducted on the patient's vital signs, symptoms and signs, lower limb Doppler ultrasound examination, patient PTS score (Villalta score), quality of life score (QOL), etc. at 3, 6, and 12 months. Adverse events, the presence or absence of thrombus recurrence, and re surgical intervention were recorded. This study is expected to propose a new strategy for the treatment of acute DVT in cancer patients, thereby improving the overall level of VTE prevention and treatment.
- Being tested
- mechanical thrombectomy (PMT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mechanical thrombectomy (PMT)Procedure or surgery
After the establishment of the pathway, Angiojet (Boco, USA) was used to infuse urokinase into the blood vessels of the thrombotic segment. After waiting for 15 minutes, mechanical thrombectomy was performed. After thrombectomy, the effectiveness of thrombectomy was evaluated through angiography. For residual thrombi, repeated thrombectomy was performed, with a maximum thrombectomy volume of 480ml. After thrombectomy, antegrade angiography of the dorsal vein of the foot was performed again. If iliac vein stenosis was found to be greater than 50%, Then, Mustang balloons (Boko, USA) that match the normal blood vessel diameter are used for dilation. If the residual stenosis after dilation is greater than 30%, Wallsten stents that match the normal blood vessel diameter are inserted (Boko, USA). After all operations are completed, a dorsalis pedis venography is performed again to evaluate the thrombus burden and calculate the immediate thrombus clearance rate and thrombus clearance level.
| Study group | Role | What they receive |
|---|---|---|
| Improved approach mechanical thrombectomy (PMT) group | Other | Not described Receives: Procedure: mechanical thrombectomy (PMT) |
| Traditional simple anticoagulant group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of PTS at 12 months after surgery
Villalta Rating at 12 months after surgery
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start23 Jan 2023
- Primary completion15 Aug 2025
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer Patients With Acute Lower Limb Deep Vein Thrombosis (DVT)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06085495
- Sponsor's protocol ID
- Y031
- Status last verified
- Aug 2025
- First submitted
- 10 Oct 2023
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparative Study of Mechanical Thrombectomy and Simple Anticoagulation Therapy for Acute Lower Limb Deep Vein Thrombosis in Tumor Patients Under VTE Prevention and Control System
- ClinicalTrials.gov ID
- NCT06085495
- Acronym / sponsor ID
- Y031
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 17 Oct 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.
This study will conduct a prospective single blind controlled study on the clinical efficacy and safety indicators of 50 cancer patients with acute lower limb deep vein thrombosis (DVT). The patients were randomly divided into an experimental group (improved mechanical thrombectomy (PMT) group) and a control group (traditional simple anticoagulation group) using the "envelope method", with 25 cases each. After the end of treatment, clinical prognosis evaluations were conducted on the patient's vital signs, symptoms and signs, lower limb Doppler ultrasound examination, patient PTS score (Villalta score), quality of life score (QOL), etc. at 3, 6, and 12 months. Adverse events, the presence or absence of thrombus recurrence, and re surgical intervention were recorded. This study is expected to propose a new strategy for the treatment of acute DVT in cancer patients, thereby improving the overall level of VTE prevention and treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Improved approach mechanical thrombectomy (PMT) group | Other | Procedure: mechanical thrombectomy (PMT) |
| Traditional simple anticoagulant group | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) Between the ages of 18 and 75; 2) Suffering from acute lower limb deep vein thrombosis (DVT) with a duration of less than 14 days from onset; 3) Thrombosis involving the iliac vein, femoral vein, or popliteal vein; 4) The patient has been diagnosed with tumors, including benign or malignant tumors, including surgical or conservative treatment; 5) Sign an informed consent form.
Key exclusion criteria (1 listed)
- 1) Patients with a history of deep vein thrombosis of the same lower limb in the past; 2) Patients with plasma Cr levels greater than 180umol/L; 3) Patients with contraindications to thrombolytic drugs; 4) Patients with concomitant inferior vena cava thrombosis or simple calf intermuscular vein thrombosis; 5) Patients who are known to be allergic to heparin, low molecular weight heparin, contrast agents, etc; 6) Patients who have participated in clinical trials of drugs or other medical devices that interfere with this clinical trial within the past 3 months; 7) Pregnant and lactating women; 8) Patients with a life expectancy of less than 6 months, or those with other diseases that may cause difficulty in testing or significantly shorten the patient's life expectancy (<1 year), including severe liver disease, cardiac insufficiency, etc; 9) Patients with autoimmune thrombotic disease; 10) Patients who are unable or unwilling to participate in this trial.
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 |
|---|---|---|
| mechanical thrombectomy (PMT)After the establishment of the pathway, Angiojet (Boco, USA) was used to infuse urokinase into the blood vessels of the thrombotic segment. After waiting for 15 minutes, mechanical thrombectomy was performed. After thrombectomy, the effectiveness of thrombectomy was evaluated through angiography. For residual thrombi, repeated thrombectomy was performed, with a maximum thrombectomy volume of 480ml. After thrombectomy, antegrade angiography of the dorsal vein of the foot was performed again. If iliac vein stenosis was found to be greater than 50%, Then, Mustang balloons (Boko, USA) that match the normal blood vessel diameter are used for dilation. If the residual stenosis after dilation is greater than 30%, Wallsten stents that match the normal blood vessel diameter are inserted (Boko, USA). After all operations are completed, a dorsalis pedis venography is performed again to evaluate the thrombus burden and calculate the immediate thrombus clearance rate and thrombus clearance level. | Procedure or surgery | Improved approach mechanical thrombectomy (PMT) group |
Primary outcome
The incidence of PTS at 12 months after surgery
Time frame: 1 year
Villalta Rating at 12 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mechanical thrombectomy (PMT) in people with Cancer Patients With Acute Lower Limb Deep Vein Thrombosis (DVT), 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 29 Aug 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of PTS at 12 months after surgery (time frame: 1 year). 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 29 Aug 2025.