Acute and Subacute Iliofemoral and/or Caval Deep Vein Thrombosis: Evaluation of Mechanical Thrombectomy Systems

Recruiting

• Conditions: Thrombosis, Venous
• Interventions: Other: mechanical thrombectomy of caval and iliofemoral veins

• Registration Number: NCT06288906
• Lead Sponsor: IRCCS San Raffaele

Brief Summary

This is a physician-initiated, observational, monocentric, retrospective and prospective Study. The study is intended to assess the feasibility of mechanical thrombectomy of caval and iliofemoral veins according to normal clinical practice in adult patients with symptomatic acute or subacute ileofemoral or caval deep vein thrombosis objectively diagnosed with CT scan imaging.

Detailed Description

Subjects with bilateral DVT may be enrolled, so long as the study limb(s) meet inclusion/exclusion criteria, including IVC patency. It is recommended that in a subject with bilateral DVT, central imaging be performed prior to treatment to evaluate the status of the IVC.

All the visits and procedures described will be performed according to the diagnostic and therapeutic assignment required by clinical practice for the patients under study. Therefore, the choice of assigning the patient to the diagnostic and therapeutic procedures deemed most appropriate for each case is completely independent of the study.

Anticoagulation therapy with enoxaparin sodium (1 mg/kg twice a day) shall be initiated at least 48 hours prior to initiation of study treatment. Hemoglobin, INR, and platelet count must be obtained within 24 hours prior to the mechanical thrombectomy procedure in order to confirm eligibility. The access site is determined by the extent of occlusive disease. When treating a single limb at time, access via the popliteal vein is reasonable.

Upon completion of study treatment, the catheter and sheath shall be removed and hemostasis obtained with pressure over the insertion site followed by placement of a pressure dressing. PCB shall remain placed on both legs until hospital discharge. Anticoagulation therapy with weight based enoxaparin sodium shall also be continued through discharge. The following assessments should be performed following the completion of study treatment, according to the normal clinical practice:

* Duplex imaging (within 24 hours of the completion of treatment)

* Laboratory tests (within 24 hours of the completion of treatment)

* Collection of Adverse Events

Study Timeline

• Study First Submitted: 2024-02-26
• Study First Submitted QC: 2024-02-26
• Study First Posted: 2024-03-01
• Status Verified: 2025-03
• Study Start: 2025-03-30
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-01
• Primary Completion: 2027-03
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

All patients admitted in the Unit of Vascular Surgery with proximal DVT (inferior vena cava, and/or iliac vein, and/or common femoral vein, and/or deep femoral vein, and/or femoral vein), according to ESVS guidelines (2022).

Exclusion Criteria

• Patient treated with thrombolysis drugs within 48 hours prior to the index procedure
• Active bleeding, recent (<3 months) gastrointestinal (GI) bleeding, active peptic ulcer, severe liver dysfunction, and bleeding diathesis
• Impossibility or refusal to give informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Symptomatic deep vein thrombosis (DVT) patients	mechanical thrombectomy of caval and iliofemoral veins	-

Primary Outcome Measures

Name	Time	Method
Rate of Technical success	end of the surgical procedure	restore of vein patency with thrombus removal
Number of Participants presenting Bleeding	72 hours of mechanical thrombectomy treatment	Freedom from Major Bleeding

Trial Locations

Locations (1)

San Raffaele Hospital; 🇮🇹 Milano, Italy