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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS San Raffaele

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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

Trial population

Up to 50 patients (about 10 cases retrospective and 40 cases prospective) with symptomatic acute or subacute ileofemoral or caval deep vein thrombosis objectively diagnosed with CT scan imaging.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • mechanical thrombectomy of caval and iliofemoral veins

    Other intervention

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

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Symptomatic deep vein thrombosis (DVT) patients1 intervention

Trial outcomes

Primary outcomes

1

Rate of Technical success

restore of vein patency with thrombus removal

Time frame
end of the surgical procedure
2

Number of Participants presenting Bleeding

Freedom from Major Bleeding

Time frame
72 hours of mechanical thrombectomy treatment

Secondary outcomes

Other outcomes

Sponsors and contacts

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