[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"venous-thrombosis-deep-limbs\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:venous-thrombosis-deep-limbs":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":4},"100647474","a-registry-of-the-flowrunner-aspiration-system-for-patients-with-symptomatic-venous-thrombosis-100647474",false,"NCT07708376","A Registry of the FLOWRUNNER Aspiration System for Patients With Symptomatic Venous Thrombosis","Prospective, Multicenter, Registry of the FLOWRUNNER Aspiration System for Safety and Effectiveness in the Removal of Symptomatic Venous Thrombosis (FAST)","FAST","Eligibility Criteria:\n\n1. Adults ≥ 18 years of age.\n2. Symptomatic upper- or lower-extremity venous thrombosis.\n3. Treatment with the FLOWRUNNER Aspiration System for venous thrombectomy as part of routine care.\n4. Willing to participate, able to understand and able to voluntarily sign the Informed Consent Form (ICF) prior to the initial qualifying procedure (index procedure).\n5. Willing and able to participate and comply with all protocol-required follow-up visits and assessments.\n\nExclusion Criteria:\n\n1. Evidence of a chronic or previously undiagnosed extensive clot on the pre-procedure venogram that makes endovascular thrombectomy inappropriate. Indicators of chronic clot include significant venous narrowing, the presence of diffuse collateral vessels, partial recanalization, Inferior Vena Cava (IVC) hyperplasia, or other congenital anatomic anomalies of the IVC, iliac veins, or subclavian veins.\n2. No available upper- or lower-extremity venous access site suitable for the procedure due to absence of appropriate access, severe anatomical obstruction, scarring, or prior surgical alteration that prevents safe catheter insertion or any condition that, in the investigator's judgement, makes upper- or lower-extremity venous access technically infeasible or unsafe.\n3. Pregnant or breastfeeding at the time of enrollment.\n4. High-risk for pulmonary embolism (PE), defined as those presenting with:\n\n   * Hemodynamic instability (e.g., sustained hypotension, shock, or cardiac arrest)\n   * Requirement for thrombolytic therapy or surgical embolectomy\n   * Any condition that, in the investigator's judgment, would pose an unacceptable risk for participation in the study\n5. Presents with cardiogenic shock or is hemodynamically unstable.\n6. Any prior or current cancer diagnosis that, in the investigator's judgment, would pose an unacceptable risk or confound study outcomes including but not limited to:\n\n   * Tumor-associated venous thrombosis, defined as: venous thrombosis occurring in the context of active malignancy or cancer-related hypercoagulability\n   * Presence of metastatic disease or ongoing chemotherapy\n7. Known antiphospholipid syndrome or other high-risk coagulation disorders, including:\n\n   * Confirmed diagnosis of antiphospholipid antibody syndrome\n   * Severe inherited or acquired thrombophilia (e.g., protein C or S deficiency, antithrombin deficiency)\n   * Any coagulation disorder that, in the investigator's judgment, would pose an unacceptable risk for thrombectomy or confound study outcomes\n8. Estimated life expectancy of less than 12 months, based on the investigator's clinical judgement, available medical history, and prognostic indicators.\n9. Chronic non-ambulatory status, defined as:\n\n   * Persistent inability to walk or perform basic mobility activities due to underlying medical conditions\n   * Conditions such as advanced neurological disease, severe musculoskeletal impairment, or long-term paralysis\n10. Contraindicated for intravascular therapy including:\n\n    * Active bleeding\n    * Severe anemia with hemoglobin (Hb) \\\u003C 8 g\u002FdL\n    * High risk of bleeding\n    * History of heparin allergy\u002Fhypersensitivity or heparin-induced thrombocytopenia\n    * Hypersensitivity to contrast agents\n    * Contraindication to oral\u002Fintravenous anticoagulation\n    * Hypercoagulable risk\n    * Any other condition that cannot be effectively managed\n11. Renal dysfunction (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m2, not yet on dialysis).\n12. Cerebral or myocardial infarction in the last 3 months.\n13. Any condition that, in the investigator's judgment, would pose unacceptable risk or interfere with study participation, including:\n\n    * Severe allergy to contrast media\n    * Active systemic infection\n    * Uncontrolled coagulopathy\n    * Phlegmasia","ALL","18 Years",{"count":20,"type":21},218,"ESTIMATED","24 Months","OBSERVATIONAL","The objective of this study is to evaluate how well and how safe the FLOWRUNNER Aspiration System works for treating blood clots in the arms or legs in real-life medical settings.",[26,27],"Venous Thrombosis Deep (Limbs)","Venous Thrombosis",[29,30,31,32,33],"Removal of Symptomatic Venous Thrombosis","Symptomatic Venous Thrombosis","Thrombosis","Thrombectomy","Blood Clot","NOT_YET_RECRUITING","2026-07-14",{"date":37,"type":38},"2026-07-16","ACTUAL",{"date":40,"type":21},"2026-08-31",{"date":42,"type":21},"2030-11-30",{"name":44,"class":45},"FlowPhysix, Inc.","INDUSTRY",{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":64,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":4},"100626199","phase-3-design-and-rationale-of-the-colt-study-100626199","NCT07432529","Design and Rationale of the COLT Study","Design and Rationale of the COLT Study: a Multicentre, Randomised, Double-blind, Placebo-controlled Trial of COLchicine as Adjunctive Therapy to Standard Anticoagulation in Acute Proximal Deep Vein Thrombosis of the Lower Limbs","COLT","Inclusion Criteria:\n\n1. Age ≥18 years at the time of screening.\n2. Objectively confirmed first, symptomatic acute proximal lower-limb deep vein thrombosis (DVT), involving the popliteal vein or more proximal veins, diagnosed within the previous 48 hours.\n3. Planned initiation of standard anticoagulation therapy, including:\n\n   * Low-molecular-weight heparin (LMWH) bridging to vitamin K antagonists (VKA) or direct oral anticoagulants (DOACs),\n   * DOAC monotherapy according to local guidelines,\n   * Fondaparinux or other guideline-recommended regimens. Note: Standard anticoagulation regimens include dose reduction of apixaban or rivaroxaban at the sixth month, as per local practice.\n4. Ability and willingness to provide written informed consent and comply with all study procedures.\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria will be excluded:\n\n1. History of prior DVT in the same limb.\n2. Known contraindications to anticoagulation or anticipated inability to comply with study procedures.\n3. Current use of colchicine or clinical indication requiring colchicine therapy.\n4. Known hypersensitivity or allergy to colchicine.\n5. Severe hepatic impairment, defined as ALT or AST \\>3× upper limit of normal, or severe renal impairment (creatinine clearance \\\u003C30 mL\u002Fmin).\n6. Active malignancy with an estimated life expectancy \\\u003C12 months.\n7. History of active or chronic gastrointestinal disease that may interfere with colchicine tolerance, including:\n\n   1. Inflammatory bowel disease (Crohn's disease or ulcerative colitis),\n   2. Collagenous colitis,\n   3. Irritable bowel syndrome,\n   4. Chronic or recurrent diarrhea.\n8. Recent (\\\u003C30 days) or ongoing use of systemic immunosuppressive therapy, including but not limited to corticosteroids, cyclosporine, or tumor necrosis factor-alpha inhibitors.\n9. Pregnancy or breastfeeding, or unwillingness to use effective contraception during the study period.\n10. Concomitant use of strong CYP3A4 inhibitors or P-glycoprotein inhibitors contraindicated with colchicine.\n11. Major bleeding event within the past 30 days or assessed as high bleeding risk by the investigator.\n12. Inability or unwillingness to provide informed consent or to comply with study procedures.",{"count":55,"type":21},940,"INTERVENTIONAL",[58],"PHASE3","Deep vein thrombosis (DVT) is a condition in which a blood clot forms in the deep veins of the leg and can lead to long-term problems such as leg pain, swelling, and reduced quality of life. Standard treatment with blood-thinning medication lowers the risk of complications, but some patients still develop long-term damage to the veins. Inflammation is thought to play an important role in these complications.\n\nThis study will evaluate whether adding colchicine, an anti-inflammatory medication already used for other conditions, to standard anticoagulant therapy can improve outcomes in patients with acute DVT. Participants will be randomly assigned to receive either colchicine or a placebo, in addition to usual blood-thinning treatment, and will be followed for one year.\n\nThe main goal of the study is to determine whether colchicine reduces the risk of developing long-term vein problems after DVT. The study will also assess the risk of new blood clots, vein recovery, quality of life, and the safety of colchicine treatment.",[26,61,62,63],"Post-thrombotic Syndrome","Venous Thromboembolism (VTE)","Venous Insufficiency",[65,66,67,68,69,70,71],"Deep vein thrombosis","Venous thromboembolism","Post-thrombotic syndrome","Colchicine","Anticoagulation therapy","Randomized controlled trial","Inflammation","2026-02-21",{"date":74,"type":38},"2026-02-25",{"date":76,"type":21},"2026-06-01",{"date":78,"type":21},"2027-06-01",{"name":80,"class":81},"Azienda Sanitaria Locale ASL 6, Livorno","OTHER_GOV"]