A Clinical Evaluation of the Efemoral Vascular Scaffold System [EVSS] for the Treatment of Patients with Symptomatic Peripheral Vascular Disease from Stenosis or Occlusion of the Femoropopliteal Artery (NCT04584632)

This trial is looking at a new treatment called the Efemoral Vascular Scaffold System (EVSS), a tiny dissolvable scaffold coated with medication that helps keep blood flowing in narrowed or blocked leg arteries. VSS is designed to support the artery while it heals and then gradually dissolve, leaving the vessel free to move naturally. This may improve circulation, reduce symptoms like leg pain when walking, and support long-term artery health.

Trial phase

Phase 1

Trial participation type

This trial has been designed for the Clinical Research of a Device.

Principal investigator

Prof Gerard Goh

Key inclusion data

Inclusion: Patient is diagnosed as having symptomatic peripheral vascular occlusive disease (Rutherford-Becker Clinical Category 2-4); Patient agrees to undergo all protocol-required follow-up examinations and requirements at the investigational site; Patient is able to take antiplatelet and/or anticoagulant agents as prescribed. Exclusions: Patient has a known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, ticagrelor or sirolimus, or with contrast sensitivity for which the patient cannot be adequately pre-medicated; Patient is unable to walk.