- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03489135
The Venous Thrombus Extraction (VETEX) Clinical Study: A Preliminary Investigation (VETEX)
May 18, 2021 updated by: Vetex Medical Ltd.
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Burgas, Bulgaria, 73
- City Clinic Burgas
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Sofia, Bulgaria, 1407
- City Clinic Sofia
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Arnsberg, Germany, 59759
- Klinikum Hochsauerland Gmbh
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Galway, Ireland
- University Hospital Galway
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London, United Kingdom, SE1 7EH
- Guys and St. Thomas
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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investigation-related procedure not part of standard medical care, and with the understanding that consent may be withdrawn at any time without prejudice to future medical care.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.
- Subjects willing to undergo pre-and post-clinical investigation blood and urine investigations.
- Good Functional Status as determined by the physician
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
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Intervention using the ReVene Thrombectomy Catheter
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).
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Endovascular treatment of an acute iliofemoral DVT
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Primary Performance Outcome
Time Frame: 0 days
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• 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
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0 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 13, 2018
Primary Completion (ACTUAL)
March 3, 2020
Study Completion (ACTUAL)
May 7, 2021
Study Registration Dates
First Submitted
March 28, 2018
First Submitted That Met QC Criteria
March 28, 2018
First Posted (ACTUAL)
April 5, 2018
Study Record Updates
Last Update Posted (ACTUAL)
May 21, 2021
Last Update Submitted That Met QC Criteria
May 18, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VETEX
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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