Phase
Condition
Thrombosis
Deep Vein Thrombosis
Venous Thrombosis
Treatment
Aspirin
Rivaroxaban
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: IC1. Subjects who were diagnosed with deep venous thrombus (DVT) with ipsilateral iliacvenous stenosis (>50%). The ipsilateral iliac venous stenosis can be caused either by iliacvein compression (i.e. Cockett syndrome) or residue iliac venous thrombus afterpercutaneous mechanic thrombectomy. IC2. Subjects who accepted percutaneous mechanic thrombectomy (PMT) to decrease the burdenof thrombus, with or without catheter directed thrombolysis (CDT). IC3. Subjects who accepted iliac venous stent(s) implantation during the perioperativeperiod of PMT or CDT (≤30 days post PMT or CDT) .
Exclusion
Exclusion Criteria: EC1. Subject has chronic DVT or the onset of DVT is longer than 3 weeks, or chronic DVT. EC2. Subject has isolated distal DVT, which does not affect ipsilateral femoral or iliacvein. EC3. Subject has glomerular filtration rate < 60ml/min. EC4. Subject has ipsilateralvaricose vein or suffers from ipsilateral venous insufficiency prior to the DVT. Themanifestations of venous insufficiency include skin pigmentation, edema,lipodermatosclerosis and venous ulcer. EC5. Subject has acute arterial embolism on either side or suffers from known moderate orgreater stenosis at abdominal aorta, ipsilateral iliac artery and ipsilateral lowerextremity artery. EC6. Subject has known aneurysm(s) or current limiting dissection at abdominal aorta,ipsilateral iliac artery and ipsilateral lower extremity artery. EC7. Subject has contraindication to antiplatelet drugs or anticoagulants. EC8. Subject hassystemic disease(s) that cannot be treated by current medicine. EC9. Subject has been taking anticoagulants or antiplatelet drugs for other diseases priorto the DVT. EC10. Subject less than 18 years old or rejected to join this study. EC11. Subject hasmyocardial infarction during the past 6 months. EC12. EC12. Subject who is at high bleedingrisk*.
- Subject who has at least one of the below conditions will be considered at high bleedingrisk: Primary history of intracerebral haemorrhage or ischemic stroke, history of otherintracranial pathology, recent gastrointestinal bleeding or anaemia due to possiblegastrointestinal blood loss, other gastrointestinal pathology associated with increasedbleeding risk, liver failure, bleeding diathesis or coagulopathy, extreme old age orfrailty, or renal failure requiring dialysis or with eGFR <15ml/min/1.73 m2.
Study Design
Study Description
Connect with a study center
The First Affliated Hospital, Zhejiang University, School of Medicine
Hangzhou, Zhejiang
ChinaActive - Recruiting
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