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| Name | Class |
|---|---|
| Imperial College London | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Percutaneous coronary intervention | Active Comparator | Percutaneous coronary intervention (PCI) for chronic total occlusion (CTO). |
|
| Placebo percutaneous coronary intervention | Placebo Comparator | Placebo procedure for chronic total occlusion (CTO). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous coronary intervention | Procedure | Percutaneous coronary intervention using drug eluting stents and contemporary CTO PCI techniques on background of optimal medical therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in angina symptom ordinal scale score between groups | Change in angina symptom ordinal scale score between groups | 24 & 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 24 & 26 weeks |
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Inclusion Criteria:
ORBITA CTO will enrol patients who meet all 5 of the following criteria:
Accepted for CTO PCI procedure by a specialist CTO operator.
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.
Clinical evidence of ischaemia in CTO territory on dobutamine stress echocardiography, nuclear myocardial perfusion scan, stress perfusion CMR or PET).
Evidence of viability: If left ventricular angiogram or echocardiogram demonstrates LV impairment or RWMA then viability must be demonstrated.
J-CTO score ≤ 3.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Davies, MRCP PhD | Essex Cardiothoracic Centre, UK | Principal Investigator |
| Sarosh Khan, MRCP | Essex Cardiothoracic Centre, UK | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Essex Cardiothoracic Centre | Basildon | Essex | SS16 5NL | United Kingdom | ||
| Royal Bournemouth Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41999379 | Derived | Khan S, Sajjad U, Fawaz S, Butt H, Simpson R, Ibrahim A, Robertson C, Kelly P, Mohdnazri SR, Tang K, Cook CM, Demir OM, O'Kane P, Spratt JC, Brilakis ES, Karamasis GV, Shun-Shin M, Al-Lamee R, Keeble TR, Davies JR; ORBITA-CTO Investigators. Randomized, Placebo-Controlled Trial of Chronic Total Occlusion Percutaneous Coronary Intervention in Stable Angina: The ORBITA-CTO Trial. J Am Coll Cardiol. 2026 Mar 29:S0735-1097(26)05745-1. doi: 10.1016/j.jacc.2026.03.027. Online ahead of print. |
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|
| Placebo percutaneous coronary intervention | Procedure | Placebo percutaneous coronary intervention procedure on background of optimal medical therapy. |
|
| SAQ summary score |
SAQ summary score |
| 24 & 26 weeks |
| Quality of life as measured by EQ-5D-5L | Quality of life as measured by EQ-5D-5L | 24 & 26 weeks |
| Change in Rose dyspnea scale | Change in Rose dyspnea scale | 24 & 26 weeks |
| Change in peak VO2 and VO2 at AT | Change in peak VO2 and VO2 at AT | 24 weeks |
| Fidelity of blinding using Bang's blinding index (BI) | Fidelity of blinding using Bang's blinding index (BI) | 24 weeks |
| Protocol adherence | Proportion of participants adherent to allocated randomised treatment | 26 weeks |
| Bournemouth |
| BH7 7DW |
| United Kingdom |
| St. George's University Hospitals NHS Foundation Trust | London | United Kingdom |
| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| D000787 | Angina Pectoris |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| D000800 | Angioplasty, Balloon |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D017130 | Angioplasty |
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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