Condition: Ischemic Heart Disease · Chronic Total Occlusion of Coronary Artery · Sponsor: Aarhus University Hospital Skejby
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 …
This description comes directly from the study's public registry record.
Evald Christiansen, MD PhD · +45 78452028 · evald.christiansen@dadlnet.dk
Emil N Holck, MD · +45 31419472 · eh@clin.au.dk
Always discuss trial participation with your own doctor first.
| Aarhus University Hospital | Aarhus N, Denmark | Recruiting |
| Rigshospitalet | Copenhagen, Denmark | Recruiting |
| Gentofte Hospital | Hellerup, Denmark | Recruiting |
| Odense University Hospital | Odense, Denmark | Recruiting |
| Zealand University Hospital | Roskilde, Denmark | Recruiting |
| North-Estonia Medical Centre | Tallinn, Estonia | Recruiting |
| Helsinki University Central Hospital | Helsinki, Finland | Active Not Recruiting |
| Kuopio University Hospital | Kuopio, Finland | Active Not Recruiting |
| Heart Hospital Tampere | Tampere, Finland | Recruiting |
| Turku University Hospital | Turku, Finland | Recruiting |
| Clinique Louis Pasteur | Essey-lès-Nancy, France | Active Not Recruiting |
| Cardiovascular Institute, Groupe Hospitalier Mutualiste | Grenoble, France | Recruiting |
+ 15 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT03563417