Reducing Ischemia With CTO PCI: Good News, But Questions Remain.
Stéphane Rinfret, Pratik B Sandesara
https://pubmed.ncbi.nlm.nih.gov/34238552Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID03563417
International Randomized Trial on Revascularization versus Optimal Medical Therapy for Chronic Total Coronary Occlusions with Myocardial Ischemia - ISCHEMIA-CTO Trial
Led by Aarhus University Hospital Skejby · Updated on 2026-01-02
1560
Participants Needed
27
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the outcomes of treating chronic total occlusion (CTO) in coronary arteries, a condition linked to worse heart health compared to other coronary artery diseases. The study investigates whether using the latest drug-eluting stents in a procedure called Percutaneous Coronary Intervention (PCI) is better than optimal medical therapy (OMT) alone. It focuses on two groups: asymptomatic patients with significant myocardial ischemia and symptomatic patients with moderate ischemia, to understand effects on major cardiovascular events and quality of life. All participants will begin with three months of optimal medical therapy. After this, they will be assigned to one of two groups based on symptoms and ischemia level: Cohort A includes asymptomatic patients with at least 10% ischemia, randomized to PCI or continued OMT; Cohort B includes symptomatic patients with at least 5% ischemia, also randomized to PCI or OMT, with the option for PCI after six months if symptoms persist. An additional Cohort C includes patients who do not meet criteria for randomization but will be followed in a registry. Participants will undergo regular follow-ups for up to five years in Cohort A and six months in Cohort B. Researchers will assess major adverse cardiovascular and cerebrovascular events (MACCE) and quality of life using the Seattle Angina Questionnaire. Before randomization, patients will be monitored for symptom class and ischemia levels using nuclear imaging. Safety and health status will be tracked through clinical visits, with the study aiming to provide clearer evidence on CTO treatment benefits and risks over time.
CONDITIONS
Brief Title
ISCHEMIA-CTO Trial - Revascularisation or Optimal Medical Therapy of CTO
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Chronic total occlusion (CTO) in a native coronary artery
- Myocardial ischemia in the area supplied by the CTO assessed by nuclear imaging
- Age 18 years or older
- Able to provide written informed consent and willing to comply with follow-up
- Target artery diameter of 2.5 mm or larger
- Completion of 3 months of optimal medical therapy before randomization
- Asymptomatic patients with CCS class less than 2 and SAQ quality of life score above 60 with myocardial ischemia of 10% or more (Cohort A)
- Symptomatic patients with CCS class 2 or higher and/or SAQ quality of life score 60 or less with myocardial ischemia of 5% or more (Cohort B)
You will not qualify if you...
- Heart attack (NSTEMI or STEMI) within the past month
- Coronary anatomy unsuitable for CTO procedure
- Coronary artery disease requiring bypass surgery after heart team evaluation
- Life expectancy less than 2 years
- Severe chronic pulmonary disease with FEV1 less than 30% predicted
- Contraindication to dual anti-platelet therapy
- Pregnancy
- Severe kidney impairment with eGFR less than 30 mL/min/1.73 m²
- In multi-vessel disease, unsafe to treat non-CTO lesion first
- Severe valvular heart disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Run-in Period
Duration - 3 months
Participants undergo a 3-month period of optimal medical therapy to stabilize their condition before randomization.
Treatment
Duration - Up to 6 months or as per assigned treatment plan
Participants are randomized to receive either Percutaneous Coronary Intervention (PCI) or continue with optimal medical therapy (OMT) to manage chronic total occlusion.
1 baseline visit and follow-up visits depending on assigned treatment
Follow-up
Duration - Up to 10 years
Participants are followed to assess long-term outcomes including major adverse cardiovascular events and quality of life.
Periodic visits depending on cohort assignment
Trial Site Locations
Total: 27 locations
1
Aarhus University Hospital
Aarhus N, Denmark, 8200
Actively Recruiting
2
Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
3
Gentofte Hospital
Hellerup, Denmark, 2900
Actively Recruiting
4
Odense University Hospital
Odense, Denmark, 5000
Actively Recruiting
5
Zealand University Hospital
Roskilde, Denmark, 4000
Actively Recruiting
6
North-Estonia Medical Centre
Tallinn, Estonia, 13419
Actively Recruiting
7
Helsinki University Central Hospital
Helsinki, Finland, 00029
Active, Not Recruiting
8
Kuopio University Hospital
Kuopio, Finland, 70210
Active, Not Recruiting
9
Heart Hospital Tampere
Tampere, Finland, 33520
Actively Recruiting
10
Turku University Hospital
Turku, Finland, 20521
Actively Recruiting
11
Clinique Louis Pasteur
Essey-lès-Nancy, France, 54270
Active, Not Recruiting
12
Cardiovascular Institute, Groupe Hospitalier Mutualiste
Grenoble, France, 38000
Actively Recruiting
13
Hospital Germans Trias I Pujol
Badalona, Barcelona, Spain, 08916
Active, Not Recruiting
14
Hospital Galdakao
Galdakao, Bizkaia, Spain, 48960
Actively Recruiting
15
Hospital Vall de Hebron
Barcelona, Spain, 08035
Active, Not Recruiting
16
Hospital Clinic
Barcelona, Spain, 08036
Actively Recruiting
17
Hospital de Bellvitge
Barcelona, Spain, 08907
Active, Not Recruiting
18
Hospital Universitario Clinico San Carlos
Madrid, Spain, 28040
Actively Recruiting
19
Hospital la Paz
Madrid, Spain, 28046
Active, Not Recruiting
20
Hospital Universitari de Tarragona Joan XXIII
Tarragona, Spain, 43005
Actively Recruiting
21
Sahlgrenska University Hospital
Gothenburg, Sweden, 41345
Actively Recruiting
22
Skaane University Hospital (Lund)
Lund, Sweden, 22185
Active, Not Recruiting
23
Stockholm South Central Hospital (Södersjukhuset)
Stockholm, Sweden, 11883
Active, Not Recruiting
24
Belfast Health and Social Care Trust, Department of Cardiology
Belfast, United Kingdom, BT9 7AB
Active, Not Recruiting
25
University Hospital Bristol
Bristol, United Kingdom, BS1 3NU
Active, Not Recruiting
26
Barts Health NHS
London, United Kingdom, SW17 0QT
Active, Not Recruiting
27
St George's University Hospital
London, United Kingdom, SW17 0QT
Active, Not Recruiting
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Research Team
E
Evald Christiansen, MD PhD
E
Emil N Holck, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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