DVT - Deep Vein ThrombosisNCT07857850
A Prospective, Multicenter, Single-Arm Trial of Peripheral Vein Thrombectomy Stent System in Deep Venous Thrombosis
A study testing Peripheral Vein Thrombectomy Stent System in people with DVT - Deep Vein Thrombosis, run by Shanghai TENDFO Medical Technology Co., Ltd. at 6 sites in China.
Trial summary
To evaluate the safety and efficacy of peripheral vein thrombectomy stent system produced by Shanghai Tendfu Medical Technology Co., Ltd. in the treatment of acute or subacute deep venous thrombosis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- DVT - Deep Vein Thrombosis
- What is being tested?
- Peripheral Vein Thrombectomy Stent System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 6 sitesChina
- Study dates
- 1 Aug 2022to 30 Aug 2023
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged between 18 and 80 years.
- Patients diagnosed with deep venous thrombosis (DVT) within 30 days of onset via color Doppler ultrasound (CDUS) or CT venography (CTV) imaging.
- Target lesions involving the inferior vena cava, common iliac vein, external iliac vein, common femoral vein, superficial femoral vein, or popliteal vein.
- Subjects capable of understanding the purpose of the trial, who voluntarily participate and sign an informed consent form, and are willing to undergo follow-up evaluations.
Who cannot join
- Patients diagnosed with chronic-phase deep venous thrombosis (DVT) (symptom onset >30 days).
- Patients with bilateral lower extremity DVT requiring thrombus removal in both limbs.
- Patients with known bleeding disorders or bleeding tendencies (platelet count <50×10⁹/L or INR >3).
- Severe hepatic or renal dysfunction Renal insufficiency (estimated glomerular filtration rate [GFR] <30 mL/min); Active liver disease or ALT >3 × upper limit of normal (ULN).
- History of heart failure, stroke, and/or myocardial infarction within 1 month, or planned coronary/carotid revascularization or major cardiovascular/cerebrovascular surgery.
- Target lesions involving veins with a diameter <3 mm.
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- Patients with a life expectancy <12 months (e.g., malignancy).
- Patients with congenital inferior vena cava (IVC) hypoplasia/malformation or other congenital IVC/iliac vein abnormalities.
- Allergy to anticoagulants or iodine-based contrast agents.
- Bedridden patients unlikely to regain limb mobility within 1 month post-procedure.
- Patients with pre-existing venous stents or IVC filters that may interfere with device deployment.
- Patients with recurrent ipsilateral DVT.
- Pregnant or lactating women.
- High-risk pulmonary thromboembolism (PTE) (manifested by shock/hypotension: systolic blood pressure <90 mmHg or >40 mmHg drop from baseline lasting >15 minutes).
- Severe post-thrombotic syndrome (PTS) (defined as Villalta score >14 points and/or skin ulcers).
- Patients who underwent percutaneous mechanical thrombectomy within 1 month.
- Contraindications to anticoagulation (e.g., heparin-induced thrombocytopenia [HIT]).
- Contraindications to thrombolysis:
- Allergy to thrombolytic agents; High bleeding risk or active bleeding within 2 - 4 weeks (e.g., intracranial, gastrointestinal, or urinary tract hemorrhage); Recent major surgery, biopsy, CPR, or non-compressible puncture; Severe trauma within 2 - 4 weeks; Uncontrolled hypertension (>160/110 mmHg); Bacterial endocarditis; Aortic dissection, aneurysm, or arteriovenous malformation.
- History of nickel-titanium (Nitinol) alloy allergy.
- Participation in other ongoing drug/device clinical trials.
- Patients deemed ineligible by the investigator.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangzhou
The Affiliated Hospital of Qingdao University
Qingdao, Shandong
Shanghai Pudong Hospital
Shanghai
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi
Xiamen Cardiovascular Hospital Xiamen University
Xiamen, Fujian
About this study
Official title: A Prospective, Multicenter, Single-Arm Trial to Evaluate the Safety and Efficacy of the Peripheral Vein Thrombectomy Stent System in the Treatment of Deep Venous Thrombosis
To evaluate the safety and efficacy of peripheral vein thrombectomy stent system produced by Shanghai Tendfu Medical Technology Co., Ltd. in the treatment of acute or subacute deep venous thrombosis.
Read the detailed description
This project is being conducted at qualified clinical research institutions, where investigators are using a thrombectomy device developed by Shanghai Tengfu Medical Technology Co., Ltd. to treat subjects with deep vein thrombosis; it is a prospective, multicenter, single-arm clinical study utilizing a target performance value design, with subject enrollment managed via an online registration system. The primary endpoint-thrombectomy efficacy rate assessed immediately post-procedure-is used to determine whether the investigational device meets the efficacy standard, while device efficacy is further evaluated by the recurrence rate of thrombosis at the target lesion at 1, 3, and 6 months post-procedure, the incidence of post-thrombotic syndrome at 1, 3, and 6 months, device success rate, procedural success rate, and Venous Clinical Severity Score (VCSS) and Chronic Venous Insufficiency Questionnaire (CIVIQ-20) scores at 1, 3, and 6 months. Device safety is assessed based on the incidence of Major Adverse Events (MAEs) at 30 days post-procedure, as well as the incidence of adverse events and serious adverse events at 1, 3, and 6 months post-procedure.
- Conditions
- DVT - Deep Vein Thrombosis
- Being tested
- Peripheral Vein Thrombectomy Stent System
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral Vein Thrombectomy Stent SystemDevice
Tendfast™ Peripheral Vein Thrombectomy Stent System (Tendfast™) is a mechanical thrombectomy system consisting of a peripheral vein thrombectomy stent and a thrombus aspiration catheter. Guided by a guidewire, the stent is delivered to the thrombus, deployed against the vessel wall to engage, scrape, and collect the thrombus into its mesh for removal, after which manual negative-pressure aspiration through the catheter clears residual thrombus and restores blood flow.
| Study group | Role | What they receive |
|---|---|---|
| Peripheral Vein Thrombectomy Stent System | Experimental | Tendfast™ Peripheral Vein Thrombectomy Stent System Receives: Device: Peripheral Vein Thrombectomy Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thrombus clearance rate
Thrombus clearance (immediately post-procedure): The thrombus clearance rate is divided into 3 grades: Grade I is <50%; Grade II is 50%-95%; Grade III is >95%. The lower extremity veins are divided into 7 segments: inferior vena cava, common iliac vein, external iliac vein, common femoral vein, proximal superficial femoral vein, distal superficial femoral vein, and popliteal vein. Pre- and post-procedure luminal patency is visually assessed by venography: a patent lumen is scored as 0 points, partial occlusion (<50%) as 1 point, severe occlusion (50%-95%) as 2 points, and complete occlusion (95%-100%) as 3 points. The formula for the thrombus clearance rate is: (preoperative venous patency score - postoperative venous patency score) / preoperative venous patency score × 100%. A thrombus clearance rate of Grade II or above is considered effective.
Measured: immediately after the surgery
Secondary outcomes (9)
thrombus recurrence rate
Compared with before discharge, worsening of symptoms with imaging confirmation that the target lesion thrombus occludes the vessel or interrupts blood flow, requiring repeat intervention.
Measured: 1, 3, and 6 months
Post-thrombotic syndrome (PTS)
Occurrence and severity grading assessed by the Villalta score. PTS is defined as a Villalta score >4. The Villalta score includes 5 symptoms (pain, muscle cramps, heaviness, paresthesia, itching) and 6 signs (pretibial edema, pigmentation, lipodermatosclerosis, redness of the skin, superficial venous dilatation, calf muscle tenderness). Severity is classified as mild (5-9), moderate (10-14), and severe (>14 and/or presence of skin ulcer).
Measured: 1, 3, and 6 months
Device success
Successful delivery of the thrombectomy device to the target lesion, successful deployment, and successful withdrawal of the delivery system.
Measured: immediately after the surgery
Procedural success
Immediate post-procedure thrombus clearance rate of Grade II or above and no major adverse event before discharge
Measured: immediately after the surgery
Venous Clinical Severity Score (VCSS)
Evaluation of clinical symptoms by comparing improvement from baseline to post-treatment. VCSS includes 10 clinical elements (pain, varicose veins, edema, skin pigmentation, inflammation, induration, number of active ulcers, ulcer size, and use of compression therapy), each scored 0-3 by severity, with a total score of 30.
Measured: 1, 3, and 6 months
Chronic Venous Insufficiency Questionnaire (CIVIQ-20) score
Improvement/change compared with pre-operation based on the CIVIQ-20 score. CIVIQ is a specific, self-administered quality-of-life questionnaire for patients with chronic venous disease of the lower extremities. It includes 20 items across 4 domains-social, psychological, physical, and pain-and mainly reflects the impact of chronic venous insufficiency on patients' quality of life.
Measured: 1, 3, and 6 months
Major adverse events (MAE) at 30 days
all-cause death, major bleeding, new-onset symptomatic pulmonary embolism, and target lesion thrombus recurrence. Major bleeding is defined as intracranial hemorrhage or severe bleeding that leads to death, surgery, discontinuation of treatment, or transfusion. Transfusion [15] is defined as two or more units of whole blood (400 mL) or red blood cells (240 mL). Symptomatic pulmonary embolism is defined as pulmonary embolism with clinical symptoms such as dyspnea, chest pain, hemoptysis, panic, cough, or syncope. Target lesion thrombus recurrence is defined as worsening symptoms compared with before discharge, with imaging confirmation that the target lesion thrombus occludes the vessel or interrupts blood flow and requires repeat intervention.
Measured: 30 days
Adverse event rate within 12 months after surgery
Adverse event rate within 12 months after surgery
Measured: 12 months after surgery
Serious adverse event rate within 12 months after surgery
Serious adverse event rate within 12 months after surgery
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start1 Aug 2022
- Primary completion30 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DVT - Deep Vein ThrombosisStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai TENDFO Medical Technology Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07857850
- Sponsor's protocol ID
- TF02-001A
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 5 Oct 2026
- 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 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single-Arm Trial to Evaluate the Safety and Efficacy of the Peripheral Vein Thrombectomy Stent System in the Treatment of Deep Venous Thrombosis
- ClinicalTrials.gov ID
- NCT07857850
- Acronym / sponsor ID
- TF02-001A
- Conditions
- DVT - Deep Vein Thrombosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Shanghai TENDFO Medical Technology Co., Ltd.University, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 5 Oct 2026 (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.
To evaluate the safety and efficacy of peripheral vein thrombectomy stent system produced by Shanghai Tendfu Medical Technology Co., Ltd. in the treatment of acute or subacute deep venous thrombosis.
Detailed description
This project is being conducted at qualified clinical research institutions, where investigators are using a thrombectomy device developed by Shanghai Tengfu Medical Technology Co., Ltd. to treat subjects with deep vein thrombosis; it is a prospective, multicenter, single-arm clinical study utilizing a target performance value design, with subject enrollment managed via an online registration system. The primary endpoint-thrombectomy efficacy rate assessed immediately post-procedure-is used to determine whether the investigational device meets the efficacy standard, while device efficacy is further evaluated by the recurrence rate of thrombosis at the target lesion at 1, 3, and 6 months post-procedure, the incidence of post-thrombotic syndrome at 1, 3, and 6 months, device success rate, procedural success rate, and Venous Clinical Severity Score (VCSS) and Chronic Venous Insufficiency Questionnaire (CIVIQ-20) scores at 1, 3, and 6 months. Device safety is assessed based on the incidence of Major Adverse Events (MAEs) at 30 days post-procedure, as well as the incidence of adverse events and serious adverse events at 1, 3, and 6 months post-procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peripheral Vein Thrombectomy Stent System | Experimental | Device: Peripheral Vein Thrombectomy Stent SystemTendfast™ Peripheral Vein Thrombectomy Stent System |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects aged between 18 and 80 years.
- Patients diagnosed with deep venous thrombosis (DVT) within 30 days of onset via color Doppler ultrasound (CDUS) or CT venography (CTV) imaging.
- Target lesions involving the inferior vena cava, common iliac vein, external iliac vein, common femoral vein, superficial femoral vein, or popliteal vein.
- Subjects capable of understanding the purpose of the trial, who voluntarily participate and sign an informed consent form, and are willing to undergo follow-up evaluations.
Key exclusion criteria (22 listed)
- Patients diagnosed with chronic-phase deep venous thrombosis (DVT) (symptom onset >30 days).
- Patients with bilateral lower extremity DVT requiring thrombus removal in both limbs.
- Patients with known bleeding disorders or bleeding tendencies (platelet count <50×10⁹/L or INR >3).
- Severe hepatic or renal dysfunction Renal insufficiency (estimated glomerular filtration rate [GFR] <30 mL/min); Active liver disease or ALT >3 × upper limit of normal (ULN).
- History of heart failure, stroke, and/or myocardial infarction within 1 month, or planned coronary/carotid revascularization or major cardiovascular/cerebrovascular surgery.
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 |
|---|---|---|
| Peripheral Vein Thrombectomy Stent SystemTendfast™ Peripheral Vein Thrombectomy Stent System (Tendfast™) is a mechanical thrombectomy system consisting of a peripheral vein thrombectomy stent and a thrombus aspiration catheter. Guided by a guidewire, the stent is delivered to the thrombus, deployed against the vessel wall to engage, scrape, and collect the thrombus into its mesh for removal, after which manual negative-pressure aspiration through the catheter clears residual thrombus and restores blood flow. | Device | Peripheral Vein Thrombectomy Stent System |
Primary outcome
Thrombus clearance rate
Time frame: immediately after the surgery
Thrombus clearance (immediately post-procedure): The thrombus clearance rate is divided into 3 grades: Grade I is <50%; Grade II is 50%-95%; Grade III is >95%. The lower extremity veins are divided into 7 segments: inferior vena cava, common iliac vein, external iliac vein, common femoral vein, proximal superficial femoral vein, distal superficial femoral vein, and popliteal vein. Pre- and post-procedure luminal patency is visually assessed by venography: a patent lumen is scored as 0 points, partial occlusion (<50%) as 1 point, severe occlusion (50%-95%) as 2 points, and complete occlusion (95%-100%) as 3 points. The formula for the thrombus clearance rate is: (preoperative venous patency score - postoperative venous patency score) / preoperative venous patency score × 100%. A thrombus clearance rate of Grade II or above is considered effective.
9 secondary outcomes
thrombus recurrence rate
Time frame: 1, 3, and 6 months
Post-thrombotic syndrome (PTS)
Time frame: 1, 3, and 6 months
Device success
Time frame: immediately after the surgery
Procedural success
Time frame: immediately after the surgery
Venous Clinical Severity Score (VCSS)
Time frame: 1, 3, and 6 months
Chronic Venous Insufficiency Questionnaire (CIVIQ-20) score
Time frame: 1, 3, and 6 months
Major adverse events (MAE) at 30 days
Time frame: 30 days
Adverse event rate within 12 months after surgery
Time frame: 12 months after surgery
Serious adverse event rate within 12 months after surgery
Time frame: 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 5 Oct 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peripheral Vein Thrombectomy Stent System in people with DVT - Deep Vein Thrombosis, run by Shanghai TENDFO Medical Technology Co., Ltd. at 6 sites 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 22 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 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Thrombus clearance rate (time frame: immediately after the surgery). 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 5 Oct 2026.