A Prospective, Multicenter, Single-Arm Trial of Peripheral Vein Thrombectomy Stent System in Deep Venous Thrombosis

October 2, 2026 updated by: Shanghai TENDFO Medical Technology Co., Ltd.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
132

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Shanghai Pudong Hospital
    • Fujian
      • Xiamen, Fujian, China
        • Xiamen Cardiovascular Hospital Xiamen University
    • Guangzhou
      • Guangzhou, Guangzhou, China
        • The First Affiliated Hospital of Guangzhou Medical University
    • Jiangsu
      • Suzhou, Jiangsu, China
        • The Second Affiliated Hospital of Soochow University
    • Shaanxi
      • Xi'an, Shaanxi, China
        • The First Affiliated Hospital of Xi'an Jiaotong University
    • Shandong
      • Qingdao, Shandong, China
        • The Affiliated Hospital of Qingdao University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subjects aged between 18 and 80 years.
  2. Patients diagnosed with deep venous thrombosis (DVT) within 30 days of onset via color Doppler ultrasound (CDUS) or CT venography (CTV) imaging.
  3. Target lesions involving the inferior vena cava, common iliac vein, external iliac vein, common femoral vein, superficial femoral vein, or popliteal vein.
  4. 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.

Exclusion Criteria:

  1. Patients diagnosed with chronic-phase deep venous thrombosis (DVT) (symptom onset >30 days).

  2. Patients with bilateral lower extremity DVT requiring thrombus removal in both limbs.

  3. Patients with known bleeding disorders or bleeding tendencies (platelet count <50×10⁹/L or INR >3).

  4. 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).

  5. History of heart failure, stroke, and/or myocardial infarction within 1 month, or planned coronary/carotid revascularization or major cardiovascular/cerebrovascular surgery.

  6. Target lesions involving veins with a diameter <3 mm.

  7. Patients with a life expectancy <12 months (e.g., malignancy).

  8. Patients with congenital inferior vena cava (IVC) hypoplasia/malformation or other congenital IVC/iliac vein abnormalities.

  9. Allergy to anticoagulants or iodine-based contrast agents.

  10. Bedridden patients unlikely to regain limb mobility within 1 month post-procedure.

  11. Patients with pre-existing venous stents or IVC filters that may interfere with device deployment.

  12. Patients with recurrent ipsilateral DVT.

  13. Pregnant or lactating women.

  14. High-risk pulmonary thromboembolism (PTE) (manifested by shock/hypotension: systolic blood pressure <90 mmHg or >40 mmHg drop from baseline lasting >15 minutes).

  15. Severe post-thrombotic syndrome (PTS) (defined as Villalta score >14 points and/or skin ulcers).

  16. Patients who underwent percutaneous mechanical thrombectomy within 1 month.

  17. Contraindications to anticoagulation (e.g., heparin-induced thrombocytopenia [HIT]).

  18. 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.

  19. History of nickel-titanium (Nitinol) alloy allergy.

  20. Participation in other ongoing drug/device clinical trials.

  21. Patients deemed ineligible by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Peripheral Vein Thrombectomy Stent System

Tendfast™ Peripheral Vein Thrombectomy Stent System
Device: Peripheral Vein Thrombectomy Stent System

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
immediately after the surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
thrombus recurrence rate
Time Frame: 1, 3, and 6 months

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.
1, 3, and 6 months
Post-thrombotic syndrome (PTS)
Time Frame: 1, 3, and 6 months

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).
1, 3, and 6 months
Device success
Time Frame: immediately after the surgery

Successful delivery of the thrombectomy device to the target lesion, successful deployment, and successful withdrawal of the delivery system.
immediately after the surgery
Procedural success
Time Frame: immediately after the surgery

Immediate post-procedure thrombus clearance rate of Grade II or above and no major adverse event before discharge
immediately after the surgery
Venous Clinical Severity Score (VCSS)
Time Frame: 1, 3, and 6 months

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.
1, 3, and 6 months
Chronic Venous Insufficiency Questionnaire (CIVIQ-20) score
Time Frame: 1, 3, and 6 months

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.
1, 3, and 6 months
Major adverse events (MAE) at 30 days
Time Frame: 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.
30 days
Adverse event rate within 12 months after surgery
Time Frame: 12 months after surgery

Adverse event rate within 12 months after surgery
12 months after surgery
Serious adverse event rate within 12 months after surgery
Time Frame: 12 months after surgery

Serious adverse event rate within 12 months after surgery
12 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai TENDFO Medical Technology Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 5, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TF02-001A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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