Deep Vein Thrombosis LegVETEXNCT03489135
The Venous Thrombus Extraction (VETEX) Clinical Study: A Preliminary Investigation
A study testing ReVene Thrombectomy Catheter in people with Deep Vein Thrombosis Leg, run by Vetex Medical Ltd. at 5 sites in 4 countries.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Vein Thrombosis Leg
- What is being tested?
- ReVene Thrombectomy Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 13 Nov 2018to 7 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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investigation-related procedure not part of standard medical care, and with the understanding that consent may be withdrawn at any time without prejudice to future medical care.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
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- 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.
- Subjects willing to undergo pre-and post-clinical investigation blood and urine investigations.
- Good Functional Status as determined by the physician
Who cannot join
- 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)
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- Bilateral disease
- Limb-threatening circulatory compromise
- Known symptomatic Pulmonary Embolism
- Hemodynamically compromised (i.e., hypotension).
- Patients with severe dyspnea or acute systemic illness.
- Allergy, hypersensitivity, or thrombocytopenia from heparin, rt-PA, or iodinated contrast, except for mild-moderate contrast allergies for which steroid pre-medication can be used.
- Hemoglobin < 9.0 mg/dl, INR > 1.6 before warfarin was started, or platelets < 100,000/ml.
- Impaired renal function (estimated glomerular filtration rate (GFR) < 30 ml/min), defined as serum creatinine ≥133µmol/L for male and ≥125 µmol/L for female.
- Active bleeding, recent (< 3 months) gastrointestinal (GI) bleeding, severe liver dysfunction, bleeding diathesis.
- Recent (< 3 months) internal eye surgery or hemorrhagic retinopathy; recent (< 10 days) major surgery, cataract surgery, trauma, cardiopulmonary resuscitation (CPR), obstetrical delivery, or other invasive procedure.
- History of stroke or intracranial/intraspinal bleed, tumor, vascular malformation, aneurysm.
- Active cancer (metastatic, progressive, or treated within the last 6 months). Exception: patients with non-melanoma primary skin cancers are eligible to participate in the study.
- Severe hypertension on repeated readings (systolic > 180 mmHg or diastolic > 105 mmHg).
- Pregnant (positive pregnancy test, women of childbearing potential must be tested).
- Recently (< 1 month) had thrombolysis
- Life expectancy < 1 year or chronic non-ambulatory status.
- Participation in any other device study within the last year, which has not yet met the primary endpoint.
- Patient has any concurrent condition that, in the Investigator's opinion, would jeopardize the safety of the subject or compliance with the protocol.
- Likely inability to comply with the protocol or cooperate fully with the investigator and site personnel.
- Impaired liver function, defined as ALT or AST ≥2.5 times upper normal limit (UNL).
- Clinically significant, active disease (within 12 months) of the pulmonary, gastrointestinal, neurological, genitourinary or haematological system, that in the opinion of the Investigator, may confound the results of the trial or pose additional risk to the subject following use of the Vetex Thrombectomy Device.
- Cardiac disorder, defined as: congestive heart failure (New York Heart Association (NYHA) class III/IV), diagnosis of unstable angina pectoris, cerebral stroke and or myocardial infarction within the last 12 months or planned coronary or carotid revascularisation procedures.
- Atrial/Ventricular Septal Defect
- Mental incapacity, unwillingness or language barrier precluding adequate understanding of the trial procedure or cooperation with trial site personnel.
- Known or suspected abuse of alcohol, narcotics or non-prescription drugs.
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
About this study
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)
- Conditions
- Deep Vein Thrombosis Leg
- Being tested
- ReVene Thrombectomy Catheter
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReVene Thrombectomy CatheterDevice
Endovascular treatment of an acute iliofemoral DVT
| Study group | Role | What they receive |
|---|---|---|
| Intervention using the ReVene Thrombectomy Catheter | Experimental | Open label, prospective, non-randomised, multi-centre first-in-human evaluation of the Vetex ReVene Thrombectomy Catheter for treatment of acute iliofemoral deep vein thrombosis (DVT). Receives: Device: ReVene Thrombectomy Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Performance Outcome
- Procedural success, defined as successful preparation and use of the device to achieve Society Interventional Radiology (SIR) Grade II Lysis (50-95% thrombus removal) in the target vessel, with freedom from procedural related adverse events
Measured: 0 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start13 Nov 2018
- Primary completion3 Mar 2020
- Study completion7 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Vein Thrombosis LegStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vetex Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03489135
- Sponsor's protocol ID
- VETEX
- Acronym
- VETEX
- Status last verified
- May 2021
- First submitted
- 28 Mar 2018
- Last updated
- 21 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Venous Thrombus Extraction (VETEX) Clinical Study: A Preliminary Investigation
- ClinicalTrials.gov ID
- NCT03489135
- Acronym / sponsor ID
- VETEX / VETEX
- Conditions
- Deep Vein Thrombosis Leg
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Vetex Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Nov 2018 (actual)
- Primary completion
- 3 Mar 2020 (actual)
- Study completion
- 7 May 2021 (actual)
- First posted
- 5 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention using the ReVene Thrombectomy Catheter | Experimental | Device: ReVene Thrombectomy CatheterOpen label, prospective, non-randomised, multi-centre first-in-human evaluation of the Vetex ReVene Thrombectomy Catheter for treatment of acute iliofemoral deep vein thrombosis (DVT). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (31 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReVene Thrombectomy CatheterEndovascular treatment of an acute iliofemoral DVT | Device | Intervention using the ReVene Thrombectomy Catheter |
Primary outcome
Primary Performance Outcome
Time frame: 0 days
• Procedural success, defined as successful preparation and use of the device to achieve Society Interventional Radiology (SIR) Grade II Lysis (50-95% thrombus removal) in the target vessel, with freedom from procedural related adverse events
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ReVene Thrombectomy Catheter in people with Deep Vein Thrombosis Leg, run by Vetex Medical Ltd. at 5 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Bulgaria, Germany, Ireland, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Performance Outcome (time frame: 0 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2021.