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

Not Applicable

Recruiting

• Conditions: Chronic Total Occlusion of Coronary Artery; Stable Angina
• Interventions: Procedure: Percutaneous coronary intervention; Procedure: Placebo percutaneous coronary intervention

• Registration Number: NCT05142215
• Lead Sponsor: Mid and South Essex NHS Foundation Trust

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-19
• Study First Submitted: 2021-11-09
• Study First Submitted QC: 2021-11-19
• Study First Posted: 2021-12-02
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-20
• Primary Completion: 2025-10-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Percutaneous coronary intervention	Percutaneous coronary intervention	Percutaneous coronary intervention (PCI) for chronic total occlusion (CTO).
Placebo percutaneous coronary intervention	Placebo percutaneous coronary intervention	Placebo procedure for chronic total occlusion (CTO).

Primary Outcome Measures

Name	Time	Method
Change in angina symptom ordinal scale score between groups	24 & 26 weeks	Change in angina symptom ordinal scale score between groups

Secondary Outcome Measures

Name	Time	Method
Change in Rose dyspnea scale	24 & 26 weeks	Change in Rose dyspnea scale
Change in peak VO2 and VO2 at AT	24 weeks	Change in peak VO2 and VO2 at AT
Quality of life as measured by EQ-5D-5L	24 & 26 weeks	Quality of life as measured by EQ-5D-5L
Physical limitation, angina frequency, angina stability, treatment satisfaction and quality of life scores as measured by the Seattle Angina Questionnaire (SAQ)	24 & 26 weeks	Physical limitation, angina frequency, angina stability, treatment satisfaction and quality of life scores as measured by the Seattle Angina Questionnaire (SAQ)
SAQ summary score	24 & 26 weeks	SAQ summary score
Fidelity of blinding using Bang's blinding index (BI)	24 weeks	Fidelity of blinding using Bang's blinding index (BI)
Protocol adherence	26 weeks	Proportion of participants adherent to allocated randomised treatment

Trial Locations

Locations (2)

Essex Cardiothoracic Centre; 🇬🇧 Basildon, Essex, United Kingdom

Royal Bournemouth Hospital; 🇬🇧 Bournemouth, United Kingdom