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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-19

Study Completion Date

2025-10-21

Brief Summary

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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.

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Detailed Description

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Conditions

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Stable Angina Chronic Total Occlusion of Coronary Artery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Percutaneous coronary intervention

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

Group Type ACTIVE_COMPARATOR

Percutaneous coronary intervention

Intervention Type PROCEDURE

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

Placebo percutaneous coronary intervention

Placebo procedure for chronic total occlusion (CTO).

Group Type PLACEBO_COMPARATOR

Placebo percutaneous coronary intervention

Intervention Type PROCEDURE

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

Interventions

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Percutaneous coronary intervention

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

Intervention Type PROCEDURE

Placebo percutaneous coronary intervention

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

Intervention Type PROCEDURE

Other Intervention Names

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Coronary angioplasty

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No