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Clinical Trials/NCT05142215
NCT05142215CompletedNot Applicable

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

Mid and South Essex NHS Foundation Trust3 sites in 1 country50 target enrollmentStarted: October 19, 2021Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
50
Locations
3
Primary Endpoint
Change in angina symptom ordinal scale score between groups
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.
  • •Age <18years.
  • •Inability to consent.

Arms & Interventions

Percutaneous coronary intervention

Active Comparator

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

Intervention: Percutaneous coronary intervention (Procedure)

Placebo percutaneous coronary intervention

Placebo Comparator

Placebo procedure for chronic total occlusion (CTO).

Intervention: Placebo percutaneous coronary intervention (Procedure)

Outcomes

Primary Outcomes

Change in angina symptom ordinal scale score between groups

Time Frame: 24 & 26 weeks

Change in angina symptom ordinal scale score between groups

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (3)

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