Stable AnginaORBITA-CTONCT05142215
A Placebo-controlled Trial of Chronic Total Occlusion Percutaneous Coronary Intervention for the Relief of Stable Angina
A study testing Percutaneous coronary intervention in people with Stable Angina and Chronic Total Occlusion of Coronary Artery, run by Mid and South Essex NHS Foundation Trust at 3 sites in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stable Angina, Chronic Total Occlusion of Coronary Artery
- What is being tested?
- Percutaneous coronary intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 19 Oct 2021to 21 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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).
- Shortness of breath on exertion considered to be angina equivalent.
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- 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.
Who cannot join
- Acute coronary syndrome within 4 weeks.
- PCI to non-CTO lesion in prior 4 weeks as part of ACS or elective PCI.
- Non-revascularised clinically important non-CTO vessel.
- Proven ischaemia (invasive or non-invasive) in non-culprit territory.
- Contraindications to PCI or drug-eluting stent (DES) implantation.
- Inability to tolerate or contraindication to DAPT.
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- Severe valvular heart disease.
- Severe chronic pulmonary disease (FEV1 <30% of predicted value).
- Severe musculoskeletal disease resulting in immobility.
- Life expectancy <2years.
- Pregnancy.
- Age <18years.
- Inability to consent.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Essex Cardiothoracic Centre
Basildon, Essex, SS16 5NL
Royal Bournemouth Hospital
Bournemouth, BH7 7DW
St. George's University Hospitals NHS Foundation Trust
London
About this study
Official 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
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.
- Being tested
- Percutaneous coronary intervention, Placebo percutaneous coronary intervention
- Keywords
- Angina, Chronic total occlusion, Angioplasty
- Medical subject headings
- Angina, Stable, Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary interventionProcedure or surgery
Also called Coronary angioplasty
Percutaneous coronary intervention using drug eluting stents and contemporary CTO PCI techniques on background of optimal medical therapy.
Placebo percutaneous coronary interventionProcedure or surgery
Placebo percutaneous coronary intervention procedure on background of optimal medical therapy.
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous coronary intervention | Active comparator | Percutaneous coronary intervention (PCI) for chronic total occlusion (CTO). Receives: Procedure: Percutaneous coronary intervention |
| Placebo percutaneous coronary intervention | Placebo comparator | Placebo procedure for chronic total occlusion (CTO). Receives: Procedure: Placebo percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in angina symptom ordinal scale score between groups
Change in angina symptom ordinal scale score between groups
Measured: 24 & 26 weeks
Secondary outcomes (7)
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)
Measured: 24 & 26 weeks
SAQ summary score
SAQ summary score
Measured: 24 & 26 weeks
Quality of life as measured by EQ-5D-5L
Quality of life as measured by EQ-5D-5L
Measured: 24 & 26 weeks
Change in Rose dyspnea scale
Change in Rose dyspnea scale
Measured: 24 & 26 weeks
Change in peak VO2 and VO2 at AT
Change in peak VO2 and VO2 at AT
Measured: 24 weeks
Fidelity of blinding using Bang's blinding index (BI)
Fidelity of blinding using Bang's blinding index (BI)
Measured: 24 weeks
Protocol adherence
Proportion of participants adherent to allocated randomised treatment
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start19 Oct 2021
- Primary completion21 Oct 2025
- Study completion21 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stable AnginaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mid and South Essex NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College London
- Responsible party
- Sponsor
- Investigators
- John Davies, MRCP PhD, Principal investigator, Essex Cardiothoracic Centre, UKSarosh Khan, MRCP, Study director, Essex Cardiothoracic Centre, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05142215
- Sponsor's protocol ID
- 299940
- Acronym
- ORBITA-CTO
- Status last verified
- Nov 2025
- First submitted
- 9 Nov 2021
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 Jul 7;88(1):4-18. doi: 10.1016/j.jacc.2026.03.027. Epub 2026 Mar 29.
PubMed 41999379
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05142215
- Acronym / sponsor ID
- ORBITA-CTO / 299940
- Keywords
- Angina, Chronic total occlusion, Angioplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mid and South Essex NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Imperial College London
- Study start
- 19 Oct 2021 (actual)
- Primary completion
- 21 Oct 2025 (actual)
- Study completion
- 21 Oct 2025 (actual)
- First posted
- 2 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Percutaneous coronary intervention | Active comparator | Procedure: Percutaneous coronary interventionPercutaneous coronary intervention (PCI) for chronic total occlusion (CTO). |
| Placebo percutaneous coronary intervention | Placebo comparator | Procedure: Placebo percutaneous coronary interventionPlacebo procedure for chronic total occlusion (CTO). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- 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.
Key exclusion criteria (13 listed)
- Acute coronary syndrome within 4 weeks.
- PCI to non-CTO lesion in prior 4 weeks as part of ACS or elective PCI.
- Non-revascularised clinically important non-CTO vessel.
- Proven ischaemia (invasive or non-invasive) in non-culprit territory.
- Contraindications to PCI or drug-eluting stent (DES) implantation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous coronary interventionAlso: Coronary angioplastyPercutaneous coronary intervention using drug eluting stents and contemporary CTO PCI techniques on background of optimal medical therapy. | Procedure or surgery | Percutaneous coronary intervention |
| Placebo percutaneous coronary interventionPlacebo percutaneous coronary intervention procedure on background of optimal medical therapy. | Procedure or surgery | Placebo percutaneous coronary intervention |
Primary outcome
Change in angina symptom ordinal scale score between groups
Time frame: 24 & 26 weeks
Change in angina symptom ordinal scale score between groups
7 secondary outcomes
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
Time frame: 24 & 26 weeks
Quality of life as measured by EQ-5D-5L
Time frame: 24 & 26 weeks
Change in Rose dyspnea scale
Time frame: 24 & 26 weeks
Change in peak VO2 and VO2 at AT
Time frame: 24 weeks
Fidelity of blinding using Bang's blinding index (BI)
Time frame: 24 weeks
Protocol adherence
Time frame: 26 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Derived from this study: PubMed 41999379Khan 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 Jul 7;88(1):4-18. doi: 10.1016/j.jacc.2026.03.027. Epub 2026 Mar 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Davies, MRCP PhD principal investigator
Essex Cardiothoracic Centre, UK
Sarosh Khan, MRCP study director
Essex Cardiothoracic Centre, UK
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous coronary intervention in people with Stable Angina and Chronic Total Occlusion of Coronary Artery, run by Mid and South Essex NHS Foundation Trust at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in angina symptom ordinal scale score between groups (time frame: 24 & 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05142215, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.