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ISCHEMIA-CTO Trial - Revascularisation or Optimal Medical Therapy of CTO

NCT03563417 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1560

Last updated 2026-01-02

No results posted yet for this study

Summary

Study design

Prospective randomized open labeled multicenter study

Hypotheses

1. In asymptomatic patients with ≥ 10% of myocardial ischemia: PCI (Percutaneous Coronary Intervention) with latest generation of drug eluting stents is superior to optimal medical therapy in terms of relative reduction in MACCE (Major Adverse Cardiovascular and Cerebrovascular events).
2. In symptomatic patients with ≥ 5% of myocardial ischemia: PCI with latest generation of drug eluting stents is superior to optimal medical therapy (OMT) in terms of improved life quality measured as an increase of SAQ (Self Assessment Questionnaire) score of 8 points after 6 months.

Inclusion Criteria

* CTO in native coronary artery
* Myocardial ischemia in a territory supplied by CTO assessed by nuclear imaging.
* Age ≥18 yrs.
* Able to provide written Informed consent and willing to comply with the specified follow-up contacts
* Target artery ≥ 2.5 mm

Prior to randomization all patients undergo 3 months of OMT. Subsequently the population will be divided into:

Cohort A: Asymptomatic (CCS \< 2 and SAQ QoL \> 60) patients with myocardial ischemia (≥ 10% of LV) in a territory supplied by CTO

Cohort B: Symptomatic patients (CCS class ≥ 2 and/or SAQ QoL score ≤ 60 after treating non CTO lesions and after OMT) with Myocardial ischemia (5% of LV) in a territory supplied a CTO

Cohort C: patients enrolled but not randomized in cohort A or B

Exclusion criteria (for both cohort A and B)

* NSTEMI or STEMI within 1 month
* Coronary anatomy not suitable for CTO-procedure
* Coronary artery disease involving the left main/three-vessel disease with indication for CABG following heart team conference
* Life expectancy \< 2 years
* Severe chronic pulmonary disease (FEV1 \< 30 % of predicted value)
* Contraindication to dual anti-platelet therapy
* Pregnancy
* eGFR \< 30 mL/min/1.73 m2
* In multi-vessel disease: if it is deemed unsafe to treat the non-CTO lesion first.
* Severe valvular heart disease

Primary endpoint

Cohort A: Composite endpoint of MACCE (all-cause mortality, stroke, any myocardial infarction, clinically driven revascularization\*), hospitalization for heart failure or incidence of malignant arrhythmias.

\*CCS class ≥ 2 and/or QoL score \< 60. Same criteria used as for allocation to Cohort B

Cohort B: SAQ Quality of Life Assessment after 6 months.

Number of patients

1,560 (1200 in cohort A/360 in cohort B

Follow up time

Cohort A: 5 years Cohort B: 6 months

Conditions

  • Ischemic Heart Disease
  • Chronic Total Occlusion of Coronary Artery

Interventions

PROCEDURE

Percuteneous Coronary Intervention

PCI of Chronic Total Occlusions

OTHER

Optimal Medical Therapy

Initiation and titration of optimal medical therapy in the control arm.

Sponsors & Collaborators

  • Aarhus University Hospital Skejby

    lead OTHER

Principal Investigators

  • Evald Christiansen, MD PhD · Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-06
Primary Completion
2028-11-01
Completion
2032-11-01

Countries

  • Denmark
  • Estonia
  • Finland
  • France
  • Spain
  • Sweden
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03563417 on ClinicalTrials.gov