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

2026년 10월 2일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

132

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Peripheral Vein Thrombectomy Stent System

Tendfast™ Peripheral Vein Thrombectomy Stent System
장치: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Thrombus clearance rate
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
thrombus recurrence rate
기간: 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)
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 12 months after surgery

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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Shanghai TENDFO Medical Technology Co., Ltd.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2022년 8월 1일

기본 완료 (실제)

2023년 8월 30일

연구 완료 (실제)

2023년 8월 30일

연구 등록 날짜

최초 제출

2026년 9월 29일

QC 기준을 충족하는 최초 제출

2026년 10월 2일

처음 게시됨 (실제)

2026년 10월 5일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 5일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 2일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • TF02-001A

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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