ABC-ONE (Version 1): Trial of BRS use in coronary bifurcation

• Research type

  Research Study

• Full title

  THE ABSORB BIFURCATION CORONARY STUDY (ABC-ONE); A RANDOMISED TRIAL OF PROVISIONAL T-STENTING USING ABSORB BIO-ABSORBABLE SCAFFOLDS IN CORONARY BIFURCATIONS - Pilot study.

• IRAS ID

  178045

• Contact name

  James Cockburn

• Contact email

  james.cockburn@bsuh.nhs.uk

• Sponsor organisation

  Brighton and Sussex University Hospitals NHS Trust

• Duration of Study in the UK

  2 years, months, days

• Research summary

  Coronary arteries supply the heart muscle with oxygen-rich blood. They divide into branches that encircle the heart. Coronary artery disease is the narrowing or blockage of the arteries, resulting in restricted blood flow to the heart muscle. Where the narrowing involves both the main and side branch of the artery, this is called a bifurcation lesion.

  Stents have been developed to treat the narrowing in coronary arteries. They consist of a metal mesh mounted on a balloon catheter. The stent is inserted into the narrowed coronary artery and forms a permanent metal scaffold to hold the coronary artery open. There has been significant improvement in stent technology over the past 2 decades. However, the treatment of bifurcation lesions still has a higher complication rate than non bifurcation lesions.

  The CE marked Abbott Vascular bioresorbable vascular scaffold (BRS) is a new type of stent. It is inserted in a similar fashion to metal stents. However, unlike metal stents, the BRS is broken down by the body once the artery heals and is fully absorbed.

  This makes it particularly attractive for use in bifurcation lesions. The struts of metal stents permanently obstruct flow into side branches. However if the struts dissolve as with BVS, the flow in branches could improve with time in contrast to metal stents.

  To date, there has not been a trial investigating the use of BRS in bifurcation disease.

  Our study will investigate
  1. the optimal way of choosing the right size of BRS when treating bifurcation lesions and the long term outcome of patients receiving this treatment.
  2. the effect of BRS on blood flow in the small branches of stented coronary artery
  3. the degree of inflammation associated with BRS
  4. the fate of struts overlying the side branch using Optical Coherence Tomography

• REC name

  London - Brighton & Sussex Research Ethics Committee

• REC reference

  15/LO/2106

• Date of REC Opinion

  21 Jan 2016

• REC opinion

  Further Information Favourable Opinion