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)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Incidence of Post-Thrombotic Syndrome (PTS)
研究概览
简要总结
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.
详细描述
Acute lower extremity deep vein thrombosis (DVT) can lead to obstruction of veins, causing sudden lower limb swelling. Patients may also develop post-thrombotic syndrome (PTS) manifesting as recurrent lower limb swelling, skin disorders, and even non-healing ulcers, which severely affects the patient's quality of life. Among lower extremity DVT, thrombosis involving the iliofemoral veins is the most severe, with an incidence of PTS as high as 20%-50%. Percutaneous mechanical thrombectomy (PMT) utilizes mechanical aspiration to rapidly remove thrombus, relieve venous obstruction, and restore luminal patency. According to the results of a prospective clinical study, PMT can effectively improve the primary thrombus clearance rate and shorten hospital stay in patients with DVT. Among 329 patients, 192 (58.5%) achieved complete thrombus removal using the AngioJet catheter. PMT was once considered to be the first-line treatment option for DVT. However, the results of the ATTRACT study, published in 2017 in New England Journal of Medicine, sparked considerable controversy regarding the use of PMT for DVT. The ATTRACT study found that there was no significant difference in the incidence of PTS at two years after PMT compared with anticoagulation alone. Although PMT can rapidly remove thrombus, is it unable to improve the long-term outcomes for patients with DVT? According to previous studies, the primary patency rate at 12 months after PMT for acute iliofemoral venous thrombosis ranges from 77% to 85%, while the incidence of PTS at 24 months postoperatively is as high as 40%. Residual thrombus is an important cause of thrombus recurrence, re-occlusion of the vein, and poor clinical outcomes. Previous studies have primarily focused on thrombus clearance in the popliteal vein, superficial femoral vein, common femoral vein, and iliac vein, while neglecting the assessment and clearance of profunda femoris vein (PFV) thrombosis. As the PFV is an important inflow of the iliofemoral vein, whether PFV-TC can improve the patency rate and clinical outcomes of endovascular treatment for acute iliofemoral DVT remains unclear. In a preliminary study, the investigators analyzed and compared two cohorts: one receiving conventional endovascular treatment for acute iliofemoral venous thrombosis, and the other receiving conventional treatment combined with Profunda femoris vein thrombosis clearance (PFV-TC). The results showed that the 24-month patency rate of the iliofemoral vein was 90% vs. 72%, and the incidence of PTS was 11% vs. 32% (P<0.05). These findings were published in November 2025 in European Journal of Vascular and Endovascular Surgery. This study has garnered widespread attention, and de Wolf MAF published an invited commentary on this study, acknowledging the value of this approach in the endovascular treatment of acute iliofemoral DVT. Therefore, the investigators hypothesize that PFV-TC can improve inflow and reduce the incidence of PTS for iliofemoral DVT. However, high-level evidence is still lacking. The present study is a prospective, multicenter, randomized, open-label, evaluator-blinded, 1:1 parallel-controlled clinical trial investigating PFV-TC, aiming to obtain higher-level evidence to guide endovascular treatment of acute iliofemoral DVT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Due to the procedure and differences in puncture access, blinding of the patients and the interventional operators during the procedure is not feasible. Therefore, the study will be conducted as an Assessor-Blind design. To minimize bias during follow-up assessments, the evaluator responsible for assessing the primary endpoint-the incidence of Post-Thrombotic Syndrome (PTS) using the Villalta score-will be strictly blinded to the patients' treatment group allocation. The blinded evaluator will conduct follow-up visits and score assessments without access to the subjects' operative records or randomization details. Measures will be implemented to ensure that subjects are instructed not to disclose their specific treatment procedure to the follow-up assessor.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years and ≤ 85 years;
- •Diagnosed with acute iliofemoral DVT involving iliac vein, common femoral vein, and the proximal segment (orifice) of PFV (confirmed by preoperative ultrasound, CT venography, or pre-procedural venography);
- •Time from symptom onset to endovascular treatment ≤ 14 days;
- •Patient receives endovascular treatment with PMT;
- •Patient provides written informed consent.
排除标准
- •Presence of pre-existing PTS in the limb scheduled for treatment, or a history of symptomatic DVT in the same limb;
- •Concurrent symptomatic acute DVT involving the iliac vein and/or common femoral vein in the contralateral limb;
- •Known allergy to heparin, low-molecular-weight heparin, contrast media, or other relevant agents;
- •Concomitant severe pulmonary embolism with hemodynamic compromise, such as hypoxia or hypotension;
- •Intolerance to endovascular intervention due to concurrent acute systemic illness, severe dyspnea, or other contraindications;
- •Concomitant severe renal insufficiency with creatinine clearance < 30 ml/min;
- •Presence of active bleeding, severe hepatic insufficiency, bleeding diathesis, or other coagulation disorders;
- •Concomitant severe anemia (hemoglobin < 8.0 mg/dL) or thrombocytopenia (platelet count < 80,000/mL);
- •History of subarachnoid hemorrhage, intracranial hemorrhage, intracranial vascular malformation, or intracranial aneurysm;
- •Presence of other diseases (e.g., advanced malignancy, cardiac insufficiency) with an estimated life expectancy < 24 months;
- •Participation in another clinical trial of a drug or medical device within the past 1 month that may interfere with the present study;
- •Unwillingness to participate in this trial.
研究组 & 干预措施
PMT with PFV-TC group
PMT with PFV-TC group (experimental group)
干预措施: Percutaneous mechanical thrombectomy with profunda femoris vein thrombosis clearance (PMT with PFV-TC) (Procedure)
PMT without PFV-TC group
PMT without PFV-TC group (control group)
干预措施: Percutaneous mechanical thrombectomy without profunda femoris vein thrombosis clearance (PMT without PFV-TC) (Procedure)
结局指标
主要结局
Incidence of Post-Thrombotic Syndrome (PTS)
时间窗: at 24 months
Assessed by the Villalta score. The Villalta scale is the recommended tool for diagnosing and grading the severity of PTS. It is a composite score based on 11 items (5 patient-reported symptoms and 6 clinician-assessed signs), each rated from 0 (absent) to 3 (severe), yielding a total score ranging from 0 to 33. A score of 0-4 indicates no PTS, whereas a score of ≥5 or venous ulcer confirms the diagnosis of PTS. Specifically, scores of 5-9 indicate mild PTS, 10-14 indicate moderate PTS, and a score of ≥15 or venous ulcer indicates severe PTS. Higher scores reflect greater disease severity.
次要结局
- Quality of life score(at 6, 12, and 24 months)