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To evaluate the safety and efficacy of LuVo Captor suppository catheterization for the treatment of ilioffemoral vein thrombosis: a prospective, multicenter, single-group target-value clinical study

To evaluate the safety and efficacy of LuVo Captor suppository catheterization for the treatment of ilioffemoral vein thrombosis: a prospective, multicenter, single-group target-value clinical study - To evaluate the safety and efficacy of LuVo Captor suppository catheters for the treatment of iliofmoral vein thrombosis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064481
Enrollment
Unknown
Registered
2022-10-09
Start date
2022-09-30
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iliac vein thrombosis

Interventions

Experimental group:Thrombectomy catheter

Sponsors

The Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >=18 years, no gender limit; 2. Patients with acute or subacute iliofemoral vein thrombosis confirmed by definite imaging diagnostic evidence (color Doppler ultrasound or CT venography or venography); (Acute stage: duration of onset <=14 days; Subacute stage: 15 ~ 30 days of onset); 3. Patients or their legal guardians can understand the purpose of the study, are willing to cooperate with interventional surgery and follow-up, voluntarily participate in the study and sign a written informed consent.

Exclusion criteria

Exclusion criteria: 1. Angiographic exclusion criteria: the guide wire is difficult or unable to pass through the lesion; 2. Patients with symptomatic pulmonary embolism; 3. Patients with postthrombotic syndrome; 4. Target vessel with stent implantation; 5. Patients who need to use test instruments to remove bilateral iliofemoral vein thrombosis in the same operation; 6. Known combination of target lesion thrombus, bacterial endocarditis, aortic dissection, and target lesion vascular malformation; 7. Recent (within 30 days) active bleeding, including severe intracranial, digestive and urinary tract bleeding; 8. History of hemorrhagic or ischemic stroke within 3 months; 9. Chronic liver disease (e.g., liver fibrosis) or significant biochemical evidence of abnormal liver function (alanine aminotransferase/aspartate aminotransferase > 3 times the upper limit of normal); 10. Serum creatinine > 2.0 mg/dl (177 umol/L); 11. Uncontrolled hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg); 12. Those who have contraindicated the use of contrast agents, anticoagulants or suppositories; 13. Those with a life expectancy of less than 12 months; 14. Those who are pregnant or plan to become pregnant during the duration of the study; 15. Those who are participating in clinical trials of any other drug or medical device and have not yet been enrolled; 16. Other conditions that the investigator judged unsuitable for participation in the clinical trial.

Design outcomes

Primary

MeasureTime frame
Thrombosis clearance;

Countries

China

Contacts

Public ContactLu Xinwu

The Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

luxinwu@aliyun.com+86 13651839016

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026