NT-CLP-03

  • Research type

    Research Study

  • Full title

    A Prospective, Multi-Center, Non-randomized, Single arm, Open label, Supplemental Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter in Facilitating Crossing Chronic Total Occlusion (CTO) Coronary Lesions.

  • IRAS ID

    249017

  • Contact name

    Wojciech Zasada

  • Contact email

    wojciech.zasada@kcri.org

  • Sponsor organisation

    Nitiloop Ltd.

  • Duration of Study in the UK

    0 years, 6 months, 31 days

  • Research summary

    The purpose of this trial is to evaluate the safety and effectiveness of the NovaCross™ micro-catheter when used to facilitate crossing of Chronic Total Occlusion (CTO) lesions in coronary arteries. The procedure will be conducted on consenting patients diagnosed with a CTO in a coronary vessel that requires revascularization after a previously failed attempt to cross or that is refractory to 10 minutes of conventional 'workhorse' guidewire crossing.

  • REC name

    London - Chelsea Research Ethics Committee

  • REC reference

    18/LO/1723

  • Date of REC Opinion

    15 Oct 2018

  • REC opinion

    Further Information Favourable Opinion