[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641028":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":51,"collaborators":53,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":26,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":26,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":90,"whyStopped":26,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"RenJi Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"PMT with PFV-TC group","EXPERIMENTAL","PMT with PFV-TC group (experimental group)",[13],"Procedure: Percutaneous mechanical thrombectomy with profunda femoris vein thrombosis clearance (PMT with PFV-TC)",{"label":15,"type":16,"description":17,"interventionNames":18},"PMT without PFV-TC group","ACTIVE_COMPARATOR","PMT without PFV-TC group (control group)",[19],"Procedure: Percutaneous mechanical thrombectomy without profunda femoris vein thrombosis clearance (PMT without PFV-TC)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Percutaneous mechanical thrombectomy with profunda femoris vein thrombosis clearance (PMT with PFV-TC)","PMT with PFV-TC group (experimental group): Based on the control group, access is obtained via the contralateral common femoral vein using a crossover technique, or via a branch of the ipsilateral femoral vein to PFV. The thrombus status of the PFV is assessed, and PMT is performed on the PFV thrombosis. After thrombectomy, venography is performed to evaluate the patency of the PFV, and the thrombus removal grade before and after the procedure is assessed using the following scoring system: 0 points: no thrombus, patent lumen; 1 point: segmental thrombus, partially patent lumen; 2 points: segmental thrombus, occluded lumen; 3 points: fully filled with thrombus, completely occluded lumen.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Percutaneous mechanical thrombectomy without profunda femoris vein thrombosis clearance (PMT without PFV-TC)","An appropriate puncture approach is selected, including the ipsilateral calf vein, ipsilateral popliteal vein, or ipsilateral femoral vein. Under ultrasound guidance, a vascular sheath is inserted after puncture, and systemic heparinization is performed. Using a guidewire and catheter, the guidewire is advanced antegradely into the inferior vena cava to establish a pathway. After the pathway is established, PMT is performed using a mechanical thrombectomy device. Acceptable thrombectomy devices include commercially available mechanical aspiration thrombectomy devices such as the AngioJet catheter (Boston Scientific, USA) and the Acostream catheter (Acotec, China). After thrombectomy, the outcome is evaluated by venography. If iliac vein stenosis greater than 50% is detected, balloon dilation is performed using a balloon matched to the normal vessel diameter. If residual stenosis remains greater than 50% after balloon dilation, the operator decides whether to place a stent. In cases wh",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Qihong Ni","CONTACT","+8615801900772","niqihong1989@163.com",[38],{"facility":39,"status":26,"city":40,"state":26,"zip":26,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Renji hospital","Shanghai","China","CN",{"type":44,"coordinates":45},"Point",[46,47],121.45806,31.22222,{"lat":47,"lon":46},[50],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},{"type":52,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[54,56,58,60,62,64],{"name":55,"class":6},"Wenzhou Central Hospital",{"name":57,"class":6},"West China Hospital",{"name":59,"class":6},"Chengdu University of Traditional Chinese Medicine",{"name":61,"class":6},"Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University",{"name":63,"class":6},"Changhai Hospital",{"name":65,"class":6},"First People's Hospital of Hangzhou","100641028","profunda-femoris-vein-thrombosis-evaluation-and-clearance-to-improve-outcomes-of-endovascular-treatment-for-acute-iliofemoral-deep-vein-thrombosis-100641028",false,"NCT07622199","PROfunda Femoris Vein Thrombosis Evaluation and Clearance to Improve Outcomes of Endovascular Treatment for Acute Iliofemoral Deep Vein Thrombosis","PROfunda Femoris Vein Thrombosis Evaluation and Clearance to Improve Outcomes of Endovascular Treatment for Acute Iliofemoral Deep Vein Thrombosis: a Multicenter Randomized Controlled Study (The PROTECT Study)","Inclusion Criteria:\n\n1. Age ≥ 18 years and ≤ 85 years;\n2. Diagnosed with acute iliofemoral DVT involving iliac vein, common femoral vein, and PFV (confirmed by preoperative ultrasound, CT venography, or intraoperative venography);\n3. Time from symptom onset to endovascular treatment ≤ 14 days;\n4. Patient receives endovascular treatment with PMT;\n5. Patient provides written informed consent.\n\nExclusion Criteria:\n\n1. Presence of pre-existing PTS in the limb scheduled for treatment, or a history of symptomatic DVT in the same limb within the past 2 years;\n2. Concurrent symptomatic acute DVT involving the iliac vein and\u002For common femoral vein in the contralateral limb;\n3. Known allergy to heparin, low-molecular-weight heparin, contrast media, or other relevant agents;\n4. Concomitant severe pulmonary embolism with hemodynamic compromise, such as hypoxia or hypotension;\n5. Intolerance to endovascular intervention due to concurrent acute systemic illness, severe dyspnea, or other contraindications;\n6. Concomitant severe renal insufficiency with creatinine clearance \\\u003C 30 ml\u002Fmin;\n7. Presence of active bleeding, severe hepatic insufficiency, bleeding diathesis, or other coagulation disorders;\n8. Concomitant severe anemia (hemoglobin \\\u003C 8.0 mg\u002FdL) or thrombocytopenia (platelet count \\\u003C 80,000\u002FmL);\n9. History of subarachnoid hemorrhage, intracranial hemorrhage, intracranial vascular malformation, or intracranial aneurysm;\n10. Pregnancy;\n11. Presence of other diseases (e.g., advanced malignancy, cardiac insufficiency) with an estimated life expectancy \\\u003C 24 months;\n12. Participation in another clinical trial of a drug or medical device within the past 1 month that may interfere with the present study;\n13. Unwillingness to participate in this trial.","ALL","18 Years","85 Years",{"count":77,"type":78},140,"ESTIMATED","INTERVENTIONAL",[81],"NA","Patients with iliofemoral vein thrombosis are prone to developing post-thrombotic syndrome (PTS). The profunda femoris vein (PFV) is an important inflow of the iliofemoral vein. Profunda femoris vein thrombosis clearance (PFV-TC) may improve the patency of iliofemoral vein and reduce the occurrence of PTS.",[84],"Deep Vein Thrombosis",[86,87,88,89],"Deep venous thrombosis","Percutaneous mechanical thrombectomy","Post-thrombotic syndrome","Profunda femoris vein","NOT_YET_RECRUITING","2026-05-26",{"date":93,"type":94},"2026-06-03","ACTUAL",{"date":96,"type":78},"2026-07-01",{"date":98,"type":78},"2029-07-30",{"name":5,"class":6},1]