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

Primary Purpose

Stable Angina, Chronic Total Occlusion of Coronary Artery

Status

Recruiting

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Percutaneous coronary intervention

Placebo percutaneous coronary intervention

About this trial

This is an interventional treatment trial for Stable Angina focused on measuring Angina, Chronic total occlusion, Angioplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

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

Sites / Locations

Essex Cardiothoracic CentreRecruiting
Royal Bournemouth HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Percutaneous coronary intervention

Placebo percutaneous coronary intervention

Arm Description

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

Placebo procedure for chronic total occlusion (CTO).

Outcomes

Primary Outcome Measures

Change in angina symptom ordinal scale score between groups

Secondary Outcome Measures

Physical limitation, angina frequency, angina stability, treatment satisfaction and quality of life scores as measured by the Seattle Angina Questionnaire (SAQ)

SAQ summary score

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

Change in Rose dyspnea scale

Change in peak VO2 and VO2 at AT

Fidelity of blinding using Bang's blinding index (BI)

Protocol adherence

Proportion of participants adherent to allocated randomised treatment

Full Information

NCT ID

NCT05142215

First Posted

November 9, 2021

Last Updated

August 3, 2023

Sponsor

Mid and South Essex NHS Foundation Trust

Collaborators

Imperial College London

1. Study Identification

Unique Protocol Identification Number

NCT05142215

Brief Title

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

Acronym

ORBITA-CTO

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 19, 2021 (Actual)

Primary Completion Date

June 1, 2024 (Anticipated)

Study Completion Date

December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mid and South Essex NHS Foundation Trust

Collaborators

Imperial College London

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stable Angina, Chronic Total Occlusion of Coronary Artery

Keywords

Angina, Chronic total occlusion, Angioplasty

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Percutaneous coronary intervention

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo percutaneous coronary intervention

Arm Type

Placebo Comparator

Arm Description

Placebo procedure for chronic total occlusion (CTO).

Intervention Type

Procedure

Intervention Name(s)

Percutaneous coronary intervention

Other Intervention Name(s)

Coronary angioplasty

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Placebo percutaneous coronary intervention

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in angina symptom ordinal scale score between groups

Description

Change in angina symptom ordinal scale score between groups

Time Frame

24 & 26 weeks

Secondary Outcome Measure Information:

Title

Physical limitation, angina frequency, angina stability, treatment satisfaction and quality of life scores as measured by the Seattle Angina Questionnaire (SAQ)

Description

Physical limitation, angina frequency, angina stability, treatment satisfaction and quality of life scores as measured by the Seattle Angina Questionnaire (SAQ)

Time Frame

24 & 26 weeks

Title

SAQ summary score

Description

SAQ summary score

Time Frame

24 & 26 weeks

Title

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

Description

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

Time Frame

24 & 26 weeks

Title

Change in Rose dyspnea scale

Description

Change in Rose dyspnea scale

Time Frame

24 & 26 weeks

Title

Change in peak VO2 and VO2 at AT

Description

Change in peak VO2 and VO2 at AT

Time Frame

24 weeks

Title

Fidelity of blinding using Bang's blinding index (BI)

Description

Fidelity of blinding using Bang's blinding index (BI)

Time Frame

24 weeks

Title

Protocol adherence

Description

Proportion of participants adherent to allocated randomised treatment

Time Frame

26 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

John Davies, MRCP PhD

Phone

01268 524900

john.davies32@nhs.net

First Name & Middle Initial & Last Name or Official Title & Degree

Sarosh Khan, MRCP

Phone

01268 524900

Ext

4211

sarosh.khan2@nhs.net

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John Davies, MRCP PhD

Organizational Affiliation

Essex Cardiothoracic Centre, UK

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sarosh Khan, MRCP

Organizational Affiliation

Essex Cardiothoracic Centre, UK

Official's Role

Study Director

Facility Information:

Facility Name

Essex Cardiothoracic Centre

City

Basildon

State/Province

Essex

ZIP/Postal Code

SS16 5NL

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

John Davies, MRCP PhD

Phone

01268 524900

john.davies32@nhs.net

First Name & Middle Initial & Last Name & Degree

Sarosh Khan, MRCP

Phone

01268 524900

Ext

4211

sarosh.khan2@nhs.net

Facility Name

Royal Bournemouth Hospital

City

Bournemouth

ZIP/Postal Code

BH7 7DW

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Peter O'Kane, MRCP MD

peter.o'kane@uhd.nhs.uk

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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