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

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.

Study Overview

• Status: Recruiting
• Conditions: Stable Angina; Chronic Total Occlusion of Coronary Artery
• Intervention / Treatment: Procedure: Percutaneous coronary intervention; Procedure: Placebo percutaneous coronary intervention

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: John Davies, MRCP PhD; Phone Number: 01268 524900; Email: john.davies32@nhs.net
• Study Contact Backup: Name: Sarosh Khan, MRCP; Phone Number: 4211 01268 524900; Email: sarosh.khan2@nhs.net

Study Locations

• United Kingdom
  • Bournemouth, United Kingdom, BH7 7DW
    • Recruiting
    • Royal Bournemouth Hospital
    • Contact: Peter O'Kane, MRCP MD; Email: peter.o'kane@uhd.nhs.uk
  • Essex
    • Basildon, Essex, United Kingdom, SS16 5NL
      • Recruiting
      • Essex Cardiothoracic Centre
      • Contact: John Davies, MRCP PhD; Phone Number: 01268 524900; Email: john.davies32@nhs.net
      • Contact: Sarosh Khan, MRCP; Phone Number: 4211 01268 524900; Email: sarosh.khan2@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Percutaneous coronary intervention; Percutaneous coronary intervention (PCI) for chronic total occlusion (CTO).	Procedure: Percutaneous coronary intervention; Percutaneous coronary intervention using drug eluting stents and contemporary CTO PCI techniques on background of optimal medical therapy.; Other Names: Coronary angioplasty
Placebo Comparator: Placebo percutaneous coronary intervention; Placebo procedure for chronic total occlusion (CTO).	Procedure: Placebo percutaneous coronary intervention; Placebo percutaneous coronary intervention procedure on background of optimal medical therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in angina symptom ordinal scale score between groups	Change in angina symptom ordinal scale score between groups	24 & 26 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	24 & 26 weeks
SAQ summary score	SAQ summary score	24 & 26 weeks
Quality of life as measured by EQ-5D-5L	Quality of life as measured by EQ-5D-5L	24 & 26 weeks
Change in Rose dyspnea scale	Change in Rose dyspnea scale	24 & 26 weeks
Change in peak VO2 and VO2 at AT	Change in peak VO2 and VO2 at AT	24 weeks
Fidelity of blinding using Bang's blinding index (BI)	Fidelity of blinding using Bang's blinding index (BI)	24 weeks
Protocol adherence	Proportion of participants adherent to allocated randomised treatment	26 weeks

Collaborators and Investigators

• Sponsor: Mid and South Essex NHS Foundation Trust
• Collaborators: Imperial College London
• Investigators: Principal Investigator: John Davies, MRCP PhD, Essex Cardiothoracic Centre, UK; Study Director: Sarosh Khan, MRCP, Essex Cardiothoracic Centre, UK

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2021
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: November 9, 2021
• First Submitted That Met QC Criteria: November 19, 2021
• First Posted (Actual): December 2, 2021

Study Record Updates

• Last Update Posted (Actual): August 4, 2023
• Last Update Submitted That Met QC Criteria: August 3, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Angina; Angioplasty; Chronic total occlusion
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris; Angina, Stable
• Other Study ID Numbers: 299940

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No