Tests stent opening of blocked heart arteries versus medicine alone
Compares stent treatment with medicine alone in adults with blocked heart arteries and ischemia.
Plain-language title generated from the registry record
Registry title: ISCHEMIA-CTO Trial - Revascularisation or Optimal Medical Therapy of CTO
Key facts
- Where
- Badalona, Barcelona, Galdakao, Madrid, and Tarragona, SpainSee the 8 sites
Where in Spain
- Hospital Germans Trias i PujolBadalona, SpainNo longer taking part
- Hospital ClinicBarcelona, SpainTaking people
- Hospital De BellvitgeBarcelona, SpainNo longer taking part
- Hospital Vall de HebronBarcelona, SpainNo longer taking part
- Hospital GaldakaoGaldakao, SpainTaking people
- Hospital Universitario Clínico San CarlosMadrid, SpainTaking people
- Hospital La PazMadrid, SpainNo longer taking part
- Hospital Universitari de Tarragona Joan XXIIITarragona, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Aarhus University Hospital Skejby
- Trial code
- NCT03563417
- Record updated
- 2 January 2026
- Original description
Study designRead full original descriptionShow less
International Randomized Trial on the Effect of Revascularization or Optimal Medical Therapy of Chronic Total Coronary Occlusions With Myocardial Ischemia - ISCHEMIA-CTO Trial
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
Inclusion: 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: Coronary disease involving the left main/three vessel disease with indication for CABG following heart team conference; Severe chronic pulmonary disease (FEV1 < 30 % of predicted value); In multi-vessel disease: if it is deemed unsafe to treat the non-CTO lesion first; Severe valvular heart disease; Contraindication to dual anti-platelet therapy; eGFR < 30 mL/min/1.73 m2; Life expectancy < 2 years; NSTEMI or STEMI within 1 month; Coronary anatomy not suitable for CTO-procedure; Pregnancy.