The IVL-Left Main study
Research type
Research Study
Full title
Intravascular Balloon Lithotripsy in Left Main Stem Percutaneous Coronary Intervention
IRAS ID
275271
Contact name
James Spratt
Contact email
Sponsor organisation
St George's University Hospitals NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 7 months, 0 days
Research summary
Percutaneous coronary intervention (PCI), otherwise known as stenting, is now a mainstream treatment for left main coronary artery disease. Outcomes following left main stenting are strongly influenced by the mechanical result ie how well the stent is expanded. Coronary arterial calcification resists lesion preparation and optimal stent deployment, but current tools for modifying the calcium are limited. Coronary intravascular lithotripsy (IVL) is a relatively new therapy that in early clinical studies has proven effective in the treatment of calcific lesions, and is CE marked for this purpose. In patients with calcific distal left main disease, coronary IVL has the potential to significantly improve the immediate mechanical result and lead to better procedural outcomes. This study will investigate the mechanical and procedural outcomes of left main stenting with IVL in patients with obstructive calcific left main disease and a clinical indication for stenting.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
20/NE/0244
Date of REC Opinion
25 Nov 2020
REC opinion
Further Information Favourable Opinion