Anticoagulant Plus Antiplatelet Therapy Following Iliac Vein Stenting (NCT04694248) | Clinical Trial Compass
RecruitingNot Applicable
Anticoagulant Plus Antiplatelet Therapy Following Iliac Vein Stenting
China172 participantsStarted 2021-11-03
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 antiplatele…
What they're measuring
1
Primary Effectiveness Endpoints
Timeframe: 12-month follow-up
2
Primary Safety Endpoints
Timeframe: 12-month follow-up
Trial details
NCT IDNCT04694248
SponsorFirst Affiliated Hospital of Zhejiang University