An interventional study of Percutaneous coronary intervention and Placebo percutaneous coronary intervention in Stable Angina and Chronic Total Occlusion of Coronary Artery, sponsored by Mid and South Essex NHS Foundation Trust. Completed at 3 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-20.
Sponsored by Mid and South Essex NHS Foundation Trust · Not applicable, Interventional, and Treatment
ORBITA-CTO Pilot is a double blinded randomised placebo-controlled trial comparing the effects of chronic total occlusion percutaneous coronary intervention versus placebo on symptoms of angina in patients with background optimal medical therapy.
345 studies on the registry are indexed under Angina, Stable; 57 are open to participants now.
This study's enrollment of 50 is below the median of 150 across 236 interventional studies indexed under Angina, Stable.
Browse Angina, Stable studies →Mid and South Essex NHS Foundation Trust is the lead sponsor of 34 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
ORBITA CTO will enrol patients who meet all 5 of the following criteria:
Patients with symptoms related to a single vessel CTO (≥3 months duration, or probable CTO where duration is unknown) in a vessel of at least 2.5mm diameter without angiographically significant (LMS ≥50%, LAD/Cx/RCA/Graft ≥70%, ≥2mm diameter) coronary artery stenosis in remaining non-CTO vessels.
Symptoms are:
a) Typical exertional angina defined as: i) constricting discomfort in the front of the chest or in the neck, jaw, shoulder or arm ii) precipitated by physical exertion iii) relieved by rest or nitrates within 5 minutes b) Angina symptoms at rest (including decubitus angina and post-prandial angina).
c) Shortness of breath on exertion considered to be angina equivalent.
Exclusion Criteria:
Percutaneous coronary intervention (PCI) for chronic total occlusion (CTO).
Procedure: Percutaneous coronary intervention
Placebo procedure for chronic total occlusion (CTO).
Procedure: Placebo percutaneous coronary intervention
Percutaneous coronary intervention using drug eluting stents and contemporary CTO PCI techniques on background of optimal medical therapy.
Also known as: Coronary angioplasty
Placebo percutaneous coronary intervention procedure on background of optimal medical therapy.
Change in angina symptom ordinal scale score between groups
Change in angina symptom ordinal scale score between groups
Time frame: 24 & 26 weeks
Physical limitation, angina frequency, angina stability, treatment satisfaction and quality of life scores as measured by the Seattle Angina Questionnaire (SAQ)
Physical limitation, angina frequency, angina stability, treatment satisfaction and quality of life scores as measured by the Seattle Angina Questionnaire (SAQ)
Time frame: 24 & 26 weeks
SAQ summary score
SAQ summary score
Time frame: 24 & 26 weeks
Quality of life as measured by EQ-5D-5L
Quality of life as measured by EQ-5D-5L
Time frame: 24 & 26 weeks
Change in Rose dyspnea scale
Change in Rose dyspnea scale
Time frame: 24 & 26 weeks
Change in peak VO2 and VO2 at AT
Change in peak VO2 and VO2 at AT
Time frame: 24 weeks
Fidelity of blinding using Bang's blinding index (BI)
Fidelity of blinding using Bang's blinding index (BI)
Time frame: 24 weeks
Protocol adherence
Proportion of participants adherent to allocated randomised treatment
Time frame: 26 weeks
Plan to share: No
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Mid and South Essex NHS Foundation Trust