The Venous Thrombus Extraction (VETEX) Clinical Study, Rev 01

• Research type

  Research Study

• Full title

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

• IRAS ID

  245540

• Contact name

  Stephen Black

• Contact email

  stephen.black@gstt.nhs.uk

• Sponsor organisation

  Vetex Medical Ltd

• Clinicaltrials.gov Identifier

  NCT03489135

• Duration of Study in the UK

  0 years, 7 months, 28 days

• Research summary

  Deep Vein Thrombosis (DVT) is the formation of a blood clot within one of the large veins of the body, typically found in the lower leg or calf. The clot can cause partial or complete block of circulation within the vein leading to swelling, redness and tenderness of the affected area. DVT has been associated with acute complications such as Pulmonary Embolism and longer-term complications such as Post-Thrombotic Syndrome. Traditionally, primary treatment for DVT has focused on anticoagulation, rather than thrombus (clot) removal. Anticoagulation prevents the thrombus from getting larger but does not remove existing thrombus. Thrombus removal methods however, can provide immediate relief from symptoms.
  Vetex Medical Ltd have developed a mechanical thrombectomy device. The Vetex Thrombectomy Device has been designed to address some of the unmet clinical needs associated with existing thrombectomy devices; the device combines clot removal from the vessel wall and thrombus extraction functionality into a single device. The device also allows controlled and selective infusion of physician specified fluids as necessary. This clinical study will be an open-label, prospective, non-randomised, first in human trial to demonstrate the safety and performance of the Vetex Thrombectomy Device. Up to thirty patients with symptomatic peripheral vascular thrombosis who meet the inclusion criteria will be enrolled and undergo endovascular treatment of their DVT. It is anticipated that the entire study will be 8 months in duration. The study will be carried out at St Thomas' Hospital (UK) and other sites outside the UK. The study will be wholly funded by the manufacturer Vetex Medical Ltd. Anticipated clinical benefits include reduced limb swelling and pain, allowing earlier ambulation and discharge from the hospital.

• REC name

  London - Dulwich Research Ethics Committee

• REC reference

  18/LO/0754

• Date of REC Opinion

  30 Jul 2018

• REC opinion

  Further Information Favourable Opinion