Deep Vein Thrombosis Clinical Trial
Official title:
Anticoagulant Plus Antiplatelet Therapy Following Iliac Vein Stenting
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.
Status | Recruiting |
Enrollment | 172 |
Est. completion date | June 30, 2026 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | The First Affliated Hospital, Zhejiang University, School of Medicine | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
First Affiliated Hospital of Zhejiang University | Boston Scientific Corporation, Ningbo No.2 Hospital, Taizhou Enze Hospital, Taizhou First People's Hospital, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, The Central Hospital of Lishui City, Zhejiang University |
China,
Comerota AJ, Kearon C, Gu CS, Julian JA, Goldhaber SZ, Kahn SR, Jaff MR, Razavi MK, Kindzelski AL, Bashir R, Patel P, Sharafuddin M, Sichlau MJ, Saad WE, Assi Z, Hofmann LV, Kennedy M, Vedantham S; ATTRACT Trial Investigators. Endovascular Thrombus Removal for Acute Iliofemoral Deep Vein Thrombosis. Circulation. 2019 Feb 26;139(9):1162-1173. doi: 10.1161/CIRCULATIONAHA.118.037425. — View Citation
Deitelzweig SB, Johnson BH, Lin J, Schulman KL. Prevalence of clinical venous thromboembolism in the USA: current trends and future projections. Am J Hematol. 2011 Feb;86(2):217-20. doi: 10.1002/ajh.21917. — View Citation
Endo M, Jahangiri Y, Horikawa M, Kaufman JA, Schenning RC, Kolbeck KJ, Barton RE, Ohuchi Y, Liang KW, Farsad K. Antiplatelet Therapy is Associated with Stent Patency After Iliocaval Venous Stenting. Cardiovasc Intervent Radiol. 2018 Nov;41(11):1691-1698. doi: 10.1007/s00270-018-2062-5. Epub 2018 Aug 17. — View Citation
Garcia MJ, Lookstein R, Malhotra R, Amin A, Blitz LR, Leung DA, Simoni EJ, Soukas PA. Endovascular Management of Deep Vein Thrombosis with Rheolytic Thrombectomy: Final Report of the Prospective Multicenter PEARL (Peripheral Use of AngioJet Rheolytic Thrombectomy with a Variety of Catheter Lengths) Registry. J Vasc Interv Radiol. 2015 Jun;26(6):777-85; quiz 786. doi: 10.1016/j.jvir.2015.01.036. Epub 2015 Mar 29. — View Citation
Gurbel PA, Fox KAA, Tantry US, Ten Cate H, Weitz JI. Combination Antiplatelet and Oral Anticoagulant Therapy in Patients With Coronary and Peripheral Artery Disease. Circulation. 2019 Apr 30;139(18):2170-2185. doi: 10.1161/CIRCULATIONAHA.118.033580. — View Citation
Haig Y, Enden T, Grotta O, Klow NE, Slagsvold CE, Ghanima W, Sandvik L, Hafsahl G, Holme PA, Holmen LO, Njaaastad AM, Sandbaek G, Sandset PM; CaVenT Study Group. Post-thrombotic syndrome after catheter-directed thrombolysis for deep vein thrombosis (CaVenT): 5-year follow-up results of an open-label, randomised controlled trial. Lancet Haematol. 2016 Feb;3(2):e64-71. doi: 10.1016/S2352-3026(15)00248-3. Epub 2016 Jan 6. — View Citation
Langwieser N, Bernlochner I, Wustrow I, Dirschinger RJ, Jaitner J, Dommasch M, Bradaric C, Laugwitz KL, Ibrahim T. Combination of factor Xa inhibition and antiplatelet therapy after stenting in patients with iliofemoral post-thrombotic venous obstruction. Phlebology. 2016 Jul;31(6):430-7. doi: 10.1177/0268355515596289. Epub 2015 Jul 15. — View Citation
Milinis K, Thapar A, Shalhoub J, Davies AH. Antithrombotic Therapy Following Venous Stenting: International Delphi Consensus. Eur J Vasc Endovasc Surg. 2018 Apr;55(4):537-544. doi: 10.1016/j.ejvs.2018.01.007. Epub 2018 Feb 12. — View Citation
Razavi MK, Jaff MR, Miller LE. Safety and Effectiveness of Stent Placement for Iliofemoral Venous Outflow Obstruction: Systematic Review and Meta-Analysis. Circ Cardiovasc Interv. 2015 Oct;8(10):e002772. doi: 10.1161/CIRCINTERVENTIONS.115.002772. — View Citation
Rizvi SA, Ascher E, Hingorani A, Marks N. Stent patency in patients with advanced chronic venous disease and nonthrombotic iliac vein lesions. J Vasc Surg Venous Lymphat Disord. 2018 Jul;6(4):457-463. doi: 10.1016/j.jvsv.2018.02.004. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary Effectiveness Endpoints | The primary patency at 12-month follow-up evaluated by DUS | 12-month follow-up | |
Primary | Primary Safety Endpoints | The rate of major bleeding events (BARC type 5 or type 3) based on BARC definitions at 12-month follow-up. | 12-month follow-up | |
Secondary | Patency | The primary patency at 3-month and 6-month follow-up | 3-month and 6-month follow-up | |
Secondary | The rate of bleeding events | The rate of bleeding events based on BARC definitions at 3-month, 6-month and 12-month follow-up | 3-month, 6-month and 12-month follow-up | |
Secondary | The rate and severity of post-thrombotic syndrome | The rate and severity of post-thrombotic syndrome (Villalta score) at 3-month, 6-month and 12-month follow-up | 3-month, 6-month and 12-month follow-up | |
Secondary | The recurrence rate of deep venous thrombosis | The recurrence rate of deep venous thrombosis evaluated by DUS at 3-month, 6-month and 12-month follow-up | 3-month, 6-month and 12-month follow-up |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05003843 -
BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis
|
N/A | |
Recruiting |
NCT03937947 -
Traumatic Brain Injury Associated Radiological DVT Incidence and Significance Study
|
||
Withdrawn |
NCT04136561 -
Novel Strategy to Encourage Early Removal of Central Venous Catheters
|
N/A | |
Completed |
NCT03420625 -
Blood Flow Stimulation in the Lower Limbs by Application of Different External Devices
|
N/A | |
Recruiting |
NCT02507180 -
Safely Ruling Out Deep Vein Thrombosis in Pregnancy With the LEFt Clinical Decision Rule and D-Dimer
|
||
Completed |
NCT02555111 -
Xarelto Versus no Treatment for the Prevention of Recurrent Thrombosis in Patients With Chronic Portal Vein Thrombosis.
|
Phase 3 | |
Terminated |
NCT02469376 -
Evaluation of a New Imagingtechnologie for Thrombosis
|
Phase 1 | |
Completed |
NCT01975090 -
The SENTRY Clinical Study
|
N/A | |
Completed |
NCT02037607 -
Incidence of Venous Thromboembolism in Children Undergoing Elective Neurosurgical Procedures
|
N/A | |
Not yet recruiting |
NCT01357941 -
Need for Antepartum Thromboprophylaxis in Pregnant Women With One Prior Episode of Venous Thromboembolism (VTE)
|
N/A | |
Completed |
NCT00773448 -
Screening for Occult Malignancy in Patients With Idiopathic Venous Thromboembolism
|
N/A | |
Completed |
NCT00720915 -
D-dimer to Select Patients With First Unprovoked Venous Thromboembolism Who Can Have Anticoagulants Stopped at 3 Months
|
N/A | |
Completed |
NCT00771303 -
Ruling Out Pulmonary Embolism During Pregnancy:a Multicenter Outcome Study
|
||
Completed |
NCT00244725 -
Odiparcil For The Prevention Of Venous Thromboembolism
|
Phase 2 | |
Completed |
NCT00264277 -
D-dimer to Establish Duration of Anticoagulation After Venous Thromboembolism
|
Phase 4 | |
Completed |
NCT00365950 -
3 Months' Versus 6 Months' Anticoagulation in Patients With DVT and/or PE
|
Phase 4 | |
Completed |
NCT00182403 -
Fixed Dose Heparin Study
|
Phase 3 | |
Completed |
NCT03682419 -
Evaluation of Precision and Accuracy of INR Measurements in a Point of Care Device (OPTIMAL)
|
N/A | |
Not yet recruiting |
NCT04981327 -
The API-CALF Study: Apixaban to Treat Calf Vein Thrombosis
|
Phase 3 | |
Recruiting |
NCT03240120 -
A Study of Dabigatran Etexilate as Primary Treatment of Malignancy Associated Venous Thromboembolism
|
Phase 3 |