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

Official title

Acute and Subacute Iliofemoral and/or Caval Deep Vein Thrombosis: Evaluation of Mechanical Thrombectomy Systems in a Monocentric, Observational Retrospective and Prospective Study (ASTER Study)

Overview

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

Interventions

• Other mechanical thrombectomy of caval and iliofemoral veins
  investigate efficacy, safety of mechanical thrombectomy systems used in symptomatic acute and subacute ileofemoral and caval thrombosis

Primary outcome measures

• Rate of Technical success [Time frame: end of the surgical procedure]
• Number of Participants presenting Bleeding [Time frame: 72 hours of mechanical thrombectomy treatment]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Italy · 1 center

• San Raffaele Hospital — Milan

Publications

• Shaikh A, Zybulewski A, Paulisin J, Bisharat M, Mouawad NJ, Raskin A, Ichinose E, Abramowitz S, Lindquist J, Azene E, Shah N, Nguyen J, Cockrell J, Khalsa B, Khetarpaul V, Murrey DA Jr, Veerina K, Skripochnik E, Maldonado TS, Bunte MC, Annambhotla S, Schor J, Kado H, Mojibian H, Dexter D; CLOUT Investigators. Six-Month Outcomes of Mechanical Thrombectomy for Treating Deep Vein Thrombosis: Analysis PMID 37580422
• Jolly MA, Lockhart MM, Shah D, Huff CM, Valenti EA, Phillips JA, Bittar S, Botti CF, Kolluri R, Silver MJ. Outcomes from a tertiary care center using a catheter thrombectomy system for managing acute iliofemoral deep vein thrombosis. J Vasc Surg Venous Lymphat Disord. 2022 Sep;10(5):1044-1050. doi: 10.1016/j.jvsv.2022.04.010. Epub 2022 Jun 9. PMID 35691538
• Abramowitz S, Bunte MC, Maldonado TS, Skripochnik E, Gandhi S, Mouawad NJ, Mojibian H, Schor J, Dexter DJ; CLOUT study collaborators. Mechanical Thrombectomy vs. Pharmacomechanical Catheter Directed Thrombolysis for the Treatment of Iliofemoral Deep Vein Thrombosis: A Propensity Score Matched Exploratory Analysis of 12 Month Clinical Outcomes. Eur J Vasc Endovasc Surg. 2024 Apr;67(4):644-652. doi: PMID 37981003

Identifiers

NCT: NCT06288906 · ASTER Study

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗