A Placebo-controlled Trial of Chronic Total Occlusion Percutaneous Coronary Intervention for the Relief of Stable Angina

Launched by MID AND SOUTH ESSEX NHS FOUNDATION TRUST · Nov 19, 2021

Keywords

ClinConnect Summary

The ORBITA-CTO Pilot is a clinical trial designed to explore whether a specific heart procedure, called chronic total occlusion percutaneous coronary intervention (CTO PCI), can help relieve symptoms of stable angina—chest pain or discomfort caused by reduced blood flow to the heart. In this trial, some participants will receive the actual procedure while others will receive a placebo, which means they won't get the procedure but will continue their usual heart medications. This trial is currently looking for participants who are between the ages of 65 and 74 and have been experiencing angina symptoms for at least three months due to a blockage in one of their coronary arteries.

To be eligible for the trial, participants must have been approved for the CTO PCI procedure by a specialist and show signs of reduced blood flow to the affected area of the heart. They should also not have any other significant blockages in their heart arteries that could complicate the procedure. If someone joins the study, they can expect to be closely monitored for changes in their angina symptoms and overall heart health. Importantly, this trial is not open to individuals with certain medical conditions, such as severe lung disease or those who have recently experienced a heart attack, to ensure the safety and well-being of all participants.

Gender

ALL

Eligibility criteria

• 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.