NCT03489135

Brief 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)

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable

Geographic Reach
4 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 5, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

November 13, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2020

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2021

Completed
Last Updated

May 21, 2021

Status Verified

May 1, 2021

Enrollment Period

1.3 years

First QC Date

March 28, 2018

Last Update Submit

May 18, 2021

Conditions

Deep Vein Thrombosis Leg

Outcome Measures

Primary Outcomes (1)

  • 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

    0 days

Study Arms (1)

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).

Device: ReVene Thrombectomy Catheter

Interventions

ReVene Thrombectomy CatheterDEVICE

Endovascular treatment of an acute iliofemoral DVT

Intervention using the ReVene Thrombectomy Catheter

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

City Clinic Burgas

Burgas, 73, Bulgaria

Location

City Clinic Sofia

Sofia, 1407, Bulgaria

Location

Klinikum Hochsauerland GmbH

Arnsberg, 59759, Germany

Location

University Hospital Galway

Galway, Ireland

Location

Guys and St. Thomas

London, SE1 7EH, United Kingdom

Location

MeSH Terms

Conditions

Venous Thrombosis

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2018

First Posted

April 5, 2018

Study Start

November 13, 2018

Primary Completion

March 3, 2020

Study Completion

May 7, 2021

Last Updated

May 21, 2021

Record last verified: 2021-05

Locations

DE(1)BU(2)IE(1)GB(1)