CompletedNot Applicable

The Venous Thrombus Extraction (VETEX) Clinical Study: A Preliminary Investigation

Bulgaria, Germany, Ireland19 participantsStarted 2018-11-13

Plain-language summary

This is an open label, prospective, non-randomised, multi-centre first-in-human evaluation of the Vetex Thrombectomy Device for treatment of acute iliofemoral deep vein thrombosis (DVT)

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Men and women over 18 years of age
✓. Unilateral Iliofemoral DVT
✓. Patients with acute iliofemoral DVT confirmed by imaging Colour Doppler Ultrasonography (CDUS) and Magnetic Resonance Venography (MRV) or CT Venography (CTV) with symptom duration not exceeding 14 days at presentation
✓. Voluntary written consent, given before performance of any clinical investigation-related procedure not part of standard medical care, and with the understanding that consent may be withdrawn at any time without prejudice to future medical care.
✓. Female subjects must also meet any one of the following criteria:
✓. Surgically sterile with bilateral tubal ligation or hysterectomy
✓. Post-menopausal for at least one year
✓. If of child-bearing potential, a pregnancy test should be performed and they should be practicing an acceptable method of birth control for the duration of the clinical investigation as judged by the Investigator, such as condoms, foams, jellies, diaphragm, intrauterine device or abstinence.

Exclusion criteria

✕. Age less than 18 years
✕. Symptom duration \> 14 days for the DVT episode in the index leg (i.e., non-acute DVT)
✕. Inferior Vena Cava (IVC) Atresia
✕. Previously stented in treatment vein
✕. Patients with Antiphospholipid Syndrome
✕. In the index leg: established Post-Thrombotic Syndrome (PTS)
✕. Bilateral disease
✕. Limb-threatening circulatory compromise

What they're measuring

Primary Performance Outcome

Timeframe: 0 days

Trial details

NCT IDNCT03489135

SponsorVetex Medical Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-03-03

View on ClinicalTrials.gov More Deep Vein Thrombosis Leg trials