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

NCT05142215 | Completed

• 1 other identifier: 299940
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

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.

Conditions

Stable Angina; Chronic Total Occlusion of Coronary Artery

Keywords

Angina; Chronic total occlusion; Angioplasty

Outcome Measures

Primary Outcomes (1)

• Change in angina symptom ordinal scale score between groups

  Change in angina symptom ordinal scale score between groups

  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)

  24 & 26 weeks

• SAQ summary score

  24 & 26 weeks

• Quality of life as measured by EQ-5D-5L

  24 & 26 weeks

• Change in Rose dyspnea scale

  24 & 26 weeks

• Change in peak VO2 and VO2 at AT

  24 weeks

Study Arms (2)

Percutaneous coronary intervention

ACTIVE COMPARATOR

Percutaneous coronary intervention (PCI) for chronic total occlusion (CTO).

Procedure: Percutaneous coronary intervention

Placebo percutaneous coronary intervention

PLACEBO COMPARATOR

Placebo procedure for chronic total occlusion (CTO).

Procedure: Placebo percutaneous coronary intervention

Interventions

Percutaneous coronary intervention PROCEDURE

Percutaneous coronary intervention using drug eluting stents and contemporary CTO PCI techniques on background of optimal medical therapy.

Also known as: Coronary angioplasty

Percutaneous coronary intervention

Placebo percutaneous coronary intervention PROCEDURE

Placebo percutaneous coronary intervention procedure on background of optimal medical therapy.

Placebo percutaneous coronary intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.
• 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.

You may not qualify if:

• 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.
• Severe chronic pulmonary disease (FEV1 \<30% of predicted value).
• Severe musculoskeletal disease resulting in immobility.
• Life expectancy \<2years.
• Pregnancy.
• Age \<18years.
• Inability to consent.

Sponsors & Collaborators

• Mid and South Essex NHS Foundation Trust: lead
• Imperial College London: collaborator

Study Sites (3)

Essex Cardiothoracic Centre

Basildon, Essex, SS16 5NL, United Kingdom

Location

Royal Bournemouth Hospital

Bournemouth, BH7 7DW, United Kingdom

Location

St. George's University Hospitals NHS Foundation Trust

London, United Kingdom

Location

MeSH Terms

Conditions

Angina, Stable; Angina Pectoris

Interventions

Percutaneous Coronary Intervention; Angioplasty, Balloon

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Angioplasty; Catheterization; Therapeutics; Investigative Techniques

Study Officials

• John Davies, MRCP PhD

  Essex Cardiothoracic Centre, UK

  PRINCIPAL INVESTIGATOR

• Sarosh Khan, MRCP

  Essex Cardiothoracic Centre, UK

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: December 2, 2021
• Study Start: October 19, 2021
• Primary Completion: October 21, 2025
• Study Completion: October 21, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)