Percutaneous Coronary Intervention for Chronic Total Occlusion
ISCHEMIA-CTO Trial - Revascularisation or Optimal Medical Therapy of CTO
Recruiting
N/AInterventional Study
Ischemic Heart DiseaseChronic Total Occlusion of Coronary Artery
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
1,560 (estimated)
Sponsor
Aarhus University Hospital Skejby · Other
Who this trial is looking for
This trial is looking for patients with a blockage in their coronary artery who may benefit from a procedure called PCI or medication. Participants will first receive medical therapy for three months before being assigned to either the PCI treatment or continue with medication management.
Are You a Good Fit for This Trial?
Rules you outSevere valvular heart disease
You may be able to join if
I have a complete blockage in a coronary artery
I have been assessed for heart issues using nuclear imaging
I am at least 18 years old
I can provide written consent and attend follow-up visits
My target artery is at least 2.5 mm in size
You may not be able to join if
I have had a heart attack in the last month
My coronary anatomy is not suitable for the procedure
I have severe heart disease that requires surgery
I have a life expectancy of less than 2 years
I have severe chronic lung disease
I cannot take blood-thinning medications
I am pregnant
My kidney function is severely impaired
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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…
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
Trial Locations
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City
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Status
Eligibility Criteria
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 randomizati…
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
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