NT-CLP-01 NovaCross Pivotal Study

• Research type

  Research Study

• Full title

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

• IRAS ID

  170135

• Contact name

  Simon Walsh

• Contact email

  simon.walsh@belfasttrust.hscni.net

• Sponsor organisation

  Nitiloop Ltd.

• Duration of Study in the UK

  2 years, 0 months, 0 days

• Research summary

  The purpose of this trial is to evaluate the safety and effectiveness of the NovaCrossTM micro-catheter when used to facilitate crossing of Chronic Total Occlusion (CTO) lesions or complete blockages in coronary arteries. The procedure will be conducted on consenting patients diagnosed with a CTO in a coronary vessel who require a stenting procedure (commonly referred to a s percutaneous coronary intervention or PCI).

• REC name

  HSC REC B

• REC reference

  15/NI/0016

• Date of REC Opinion

  3 Mar 2015

• REC opinion

  Further Information Favourable Opinion