Overview

Anticoagulant Plus Antiplatelet Therapy Following Iliac Vein Stenting

Status:
Not yet recruiting
Trial end date:
2024-12-31
Target enrollment:
0
Participant gender:
All
Summary
To evaluate the efficacy and safety of combination of anticoagulant and antiplatelet therapy on the patency of iliac vein at 12-month post stenting in patients with acute proximal DVT and ipsilateral iliac vein stenosis who received percutaneous mechanic thrombectomy and iliac vein stenting.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
First Affiliated Hospital of Zhejiang University
Collaborators:
Affiliated Hangzhou First People's Hospital, School of Medicine, Zhejiang University
Boston Scientific Corporation
Ningbo No.2 Hospital
Taizhou Enze Hospital
Taizhou First People's Hospital
Taizhou Hospital of Zhejiang Province
The Central Hospital of Lishui City
Zhejiang University
Treatments:
Anticoagulants
Aspirin
Rivaroxaban
Criteria
Inclusion Criteria:

IC1. Subjects who were diagnosed with deep venous thrombus (DVT) with ipsilateral iliac
venous stenosis (>50%). The ipsilateral iliac venous stenosis can be caused either by iliac
vein compression (i.e. Cockett syndrome) or residue iliac venous thrombus after
percutaneous mechanic thrombectomy.

IC2. Subjects who accepted percutaneous mechanic thrombectomy (PMT) to decrease the burden
of thrombus, with or without catheter directed thrombolysis (CDT).

IC3. Subjects who accepted iliac venous stent(s) implantation during the perioperative
period of PMT or CDT (≤30 days post PMT or CDT) .

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 iliac
vein.

EC3. Subject has glomerular filtration rate < 60ml/min. EC4. Subject has ipsilateral
varicose vein or suffers from ipsilateral venous insufficiency prior to the DVT. The
manifestations 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 or
greater stenosis at abdominal aorta, ipsilateral iliac artery and ipsilateral lower
extremity 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 has
systemic disease(s) that cannot be treated by current medicine.

EC9. Subject has been taking anticoagulants or antiplatelet drugs for other diseases prior
to the DVT.

EC10. Subject less than 18 years old or rejected to join this study. EC11. Subject has
myocardial infarction during the past 6 months. EC12. EC12. Subject who is at high bleeding
risk*.

* Subject who has at least one of the below conditions will be considered at high bleeding
risk: Primary history of intracerebral haemorrhage or ischemic stroke, history of other
intracranial pathology, recent gastrointestinal bleeding or anaemia due to possible
gastrointestinal blood loss, other gastrointestinal pathology associated with increased
bleeding risk, liver failure, bleeding diathesis or coagulopathy, extreme old age or
frailty, or renal failure requiring dialysis or with eGFR <15ml/min/1.73 m2.