PROfunda Femoris Vein Thrombosis Evaluation and Clearance to Improve Outcomes of Endovascular Treatment for Acute Iliofemoral Deep Vein Thrombosis

NCT07622199 | Not Yet Recruiting DMC

• 1 other identifier: The PROTECT Study
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Deep Vein Thrombosis

Keywords

Deep venous thrombosis; Percutaneous mechanical thrombectomy; Post-thrombotic syndrome; Profunda femoris vein

Outcome Measures

Primary Outcomes (1)

• Incidence of Post-Thrombotic Syndrome (PTS)

  Assessed by the Villalta score

  at 24 months

Secondary Outcomes (7)

• Incidence of moderate-to-severe PTS

  at 6, 12, and 24 months

• Clinical classification of Clinical-Etiology-Anatomy-Pathophysiology (CEAP)

  at 6, 12, and 24 months

• Patency rate of the ipsilateral iliofemoral vein

  at 12 months and 24 months

• Incidence of PTS

  at 6 and 12 months

• Recurrence rate of symptomatic Deep Vein Thrombosis (DVT)

  at 24 months

Other Outcomes (4)

• Incidence of major bleeding

  at 24 months

• Incidence of symptomatic Pulmonary Embolism (PE)

  at 24 months

• Incidence of symptomatic Venous Thromboembolism (VTE)

  at 24 months

Study Arms (2)

PMT with PFV-TC group

EXPERIMENTAL

PMT with PFV-TC group (experimental group)

Procedure: Percutaneous mechanical thrombectomy with profunda femoris vein thrombosis clearance (PMT with PFV-TC)

PMT without PFV-TC group

ACTIVE COMPARATOR

PMT without PFV-TC group (control group)

Procedure: Percutaneous mechanical thrombectomy without profunda femoris vein thrombosis clearance (PMT without PFV-TC)

Interventions

Percutaneous mechanical thrombectomy with profunda femoris vein thrombosis clearance (PMT with PFV-TC) PROCEDURE

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.

PMT with PFV-TC group

Percutaneous mechanical thrombectomy without profunda femoris vein thrombosis clearance (PMT without PFV-TC) PROCEDURE

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

PMT without PFV-TC group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years and ≤ 85 years;
• Diagnosed with acute iliofemoral DVT involving iliac vein, common femoral vein, and PFV (confirmed by preoperative ultrasound, CT venography, or intraoperative venography);
• Time from symptom onset to endovascular treatment ≤ 14 days;
• Patient receives endovascular treatment with PMT;
• Patient provides written informed consent.

You may not qualify if:

• 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;
• 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;
• Pregnancy;
• 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.

Sponsors & Collaborators

• RenJi Hospital: lead
• Wenzhou Central Hospital: collaborator
• West China Hospital: collaborator
• Changhai Hospital: collaborator
• Chengdu University of Traditional Chinese Medicine: collaborator
• First People's Hospital of Hangzhou: collaborator
• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: collaborator

Study Sites (1)

Renji hospital

Shanghai, China

Location

MeSH Terms

Conditions

Venous Thrombosis; Postthrombotic Syndrome

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Venous Insufficiency

Central Study Contacts

Qihong Ni

CONTACT

+8615801900772; niqihong1989@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 3, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): July 30, 2029
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)