A Placebo-controlled Trial of Chronic Total Occlusion Percutaneous Coronary Intervention for the … (NCT05142215) | Clinical Trial Compass
CompletedNot Applicable
A Placebo-controlled Trial of Chronic Total Occlusion Percutaneous Coronary Intervention for the Relief of Stable Angina
United Kingdom50 participantsStarted 2021-10-19
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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.
✓. 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
✕. 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.
✕. Severe valvular heart disease.
What they're measuring
1
Change in angina symptom ordinal scale score between groups