Heart procedure put to the test: placebo surgery reveals true benefits for chest pain
NCT ID NCT05142215
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether a procedure to open a fully blocked heart artery (CTO PCI) actually reduces chest pain in people with stable angina. Fifty patients received either the real procedure or a placebo procedure, while all continued their usual heart medications. The goal was to see if the procedure offers any extra symptom relief beyond what patients already get from drugs.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Percutaneous coronary intervention (coronary angioplasty with drug-eluting stents)
- What this could lead to
- If it works, this could show that opening a fully blocked artery with a stent reduces chest pain better than a placebo procedure in people already on heart medications.
- What could go wrong
- This is a small pilot study with only 50 participants, so results may not apply to everyone. The procedure carries risks like bleeding, heart attack, or stroke, and the placebo effect can be strong for symptom relief.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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50 people
The number who actually took part.
- Started
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Oct 2021
- Finished
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Oct 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: ORBITA CTO will enrol patients who meet all 5 of the following criteria: 1. Accepted for CTO PCI procedure by a specialist CTO operator. 2. 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. 3. Clinical evidence of ischaemia in CTO territory on dobutamine stress echocardiography, nuclear myocardial perfusion scan, stress perfusion CMR or PET). 4. Evidence of viability: If left ventricular angiogram or echocardiogram demonstrates LV impairment or RWMA then viability must be demonstrated. 5. J-CTO score ≤ 3. Exclusion Criteria: 1. Acute coronary syndrome within 4 weeks. 2. PCI to non-CTO lesion in prior 4 weeks as part of ACS or elective PCI. 3. Non-revascularised clinically important non-CTO vessel. 4. Proven ischaemia (invasive or non-invasive) in non-culprit territory. 5. Contraindications to PCI or drug-eluting stent (DES) implantation. 6. Inability to tolerate or contraindication to DAPT. 7. Severe valvular heart disease. 8. Severe chronic pulmonary disease (FEV1 \<30% of predicted value). 9. Severe musculoskeletal disease resulting in immobility. 10. Life expectancy \<2years. 11. Pregnancy. 12. Age \<18years. 13. Inability to consent.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Essex Cardiothoracic Centre
Basildon, Essex, SS16 5NL, United Kingdom
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Royal Bournemouth Hospital
Bournemouth, BH7 7DW, United Kingdom
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St. George's University Hospitals NHS Foundation Trust
London, United Kingdom
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