Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-25 @ 2:12 AM
NCT ID:
NCT04542460
Eligibility Criteria:
Inclusion Criteria:
* ≥1 CTO lesion amenable to PCI.
* Stable or stabilized coronary artery disease.
* Angiographic/echocardiographic signs of reversible perfusion.
* CTO lesion in a coronary vessel supplying a significant myocardial territory (vessel diameter usually ≥3mm).
Exclusion Criteria:
* Expected survival \<1 year.
* Patients with an indication of ICD due to EF \< 35 or previous ventricular tachycardia.
* Patients with a cardiac device i.e. ICD, pacemaker or cardiac resynchronizing treatment device.
* Renal failure on dialysis.
* Lesions treated with PCI within one month.
* Indication for coronary artery bypass grafting (CABG). I.e. Two-or three vessel disease or left main disease and a syntax score \>22.
* Significant valvular heart disease.
* Declined informed consent.
* Regarding CMRI: allergy to contrast medium, severe obesity, claustrophobia and certain metallic implants.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04542460
Study Brief:
Protocol Section:
NCT04542460