ORBITA CTO Pilot
Research type
Research Study
Full title
ORBITA CTO Pilot: A comparison of the impact of CTO PCI versus placebo on angina in patients with background optimal medical therapy - a pilot study
IRAS ID
299940
Contact name
John Davies
Contact email
Sponsor organisation
Mid and South Essex NHS Foundation Trust
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Coronary artery disease is common. It can lead to narrowing of the arteries or complete blockage occurring over time of an artery called a chronic total occlusion (CTO). Patients with CTO's can have symptoms of chest pain on exertion and this is called angina. Previous studies (ORBITA trial) have shown that angioplasty for patients with narrowed arteries did not make any clinically or statistically significant difference to symptoms over intensive medical therapy. The ORBITA trial did not include patients with chronic total occlusions. Angioplasty for CTO’s is more complex, requires expensive equipment and has a higher failure rate. So far, no studies have demonstrated improvement in death/heart attack rates due to CTO PCI. However, some studies have shown improvement in symptoms in patients having stents compared to medical therapies but these were not blinded trials and therefore are open to significant biases.
We want to investigate the impact of stents on patient symptoms above medical therapy. Patients with CTO’s who have symptoms will be eligible. They will be randomised to either a stenting procedure or placebo procedure. The participants will undergo robust blinding alongside staff looking after them. Medical therapy will be administered to both groups. After 6 months patients will be unblinded. Those undergoing a placebo procedure will be offered stenting if indicated.
This study will help answer if PCI for CTO's can improve symptoms compared to a placebo procedure in patients with optimal medical therapy.
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
21/YH/0165
Date of REC Opinion
5 Aug 2021
REC opinion
Further Information Favourable Opinion