🌐 EnglishEN

AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

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

RecruitingNAAges 18 Years - anyAllAarhus University Hospital Skejby
NCT03563417 on ClinicalTrials.gov ↗
💬

In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

Sign in
📋 Eligibility rules (as published)
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 assess by nuclear imaging. Cohort C: Screening population not eligible for randomization in cohort A or B Exclusion Criteria: * NSTEMI or STEMI within 1 month * Coronary anatomy not suitable for CTO-procedure * Coronary 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
💊

What it tests

  • Percuteneous Coronary Intervention
  • Optimal Medical Therapy
📍

Where

27 sites
Aarhus University Hospital
Aarhus N, Denmark
Rigshospitalet
Copenhagen, Denmark
Gentofte Hospital
Hellerup, Denmark
Odense University Hospital
Odense, Denmark
Zealand University Hospital
Roskilde, Denmark
North-Estonia Medical Centre
Tallinn, Estonia
Helsinki University Central Hospital
Helsinki, Finland
Kuopio University Hospital
Kuopio, Finland

…and 19 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy