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:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
NCT ID:
NCT04500912
Eligibility Criteria:
Inclusion criteria:
Patients are eligible for inclusion into the study if the following criteria are met.
* Patients of 18 years and above
* Written or witnessed oral consent to participate in the study
* Native coronary artery lesions eligible for PCI with stents with no restrictions in number of lesions and stents, vessel size or lesion complexity, apart from stent thrombosis.
* Patients at high risk for bleeding according to the HBR ARC criteria: Patients meet the HBR ARC criteria if ≥1 major or ≥2 minor criteria are met.
Major HBR criteria are the following:
* Clinical indication for treatment with oral anticoagulants (OAC/NOAC) for at least 12 months
* Severe or end-stage chronic kidney failure (GFR ≤ 30 ml/min)
* Hemoglobin (Hb) level at screening \< 11g/dl or \< 6.8 mmol/l
* Spontaneous bleeding requiring hospitalization or transfusion in the past 6 months or at any time, if recurrent
* Moderate or severe baseline true thrombocytopenia (platelet count \<100 \*10\^9/L)
* History of chronic bleeding diathesis, like: leukemia, haemophilia, vitamin K deficiency, Factor V or VII deficiency etc.
* Liver cirrhosis with portal hypertension
* Active malignancy (other than skin) within the past 12 months
* Spontaneous intracranial haemorrhage ICH (at any time)
* Traumatic intracranial haemorrhage ICH within 12 months
* Presence of a brain arterio-venous malformation (AVM)
* Moderate or severe ischemic stroke within the past 6 months
* Nondeferrable major surgery on DAPT after PCI
* Recent major surgery or major trauma within 30 d before PCI
Minor HBR criteria are the following:
* Age ≥ 75 years
* Moderate chronic kidney disease (GFR \>30 and \<60 ml/min)
* Hemoglobin (Hb) 11-12.9 g/dL / 6.8-8.0 mmol/l for men and 11-11.9 g/dL / 6.8-7.4 mmol/l for women
* Any ischemic stroke at any time not meeting the major criterion
* Spontaneous bleeding requiring hospitalization or transfusion within the past 12 months
* Need for chronic treatment with steroids or non-steroidal anti-inflammatory drugs
Exclusion criteria:
Patients are not eligible if any of the following applies:
* Treated with stents other than Supraflex Cruz or Ultimaster within 6 months prior to index procedure
* Treatment of lesions with stent thrombosis
* Treatment of venous or arterial coronary grafts
* Treated for stent thrombosis in 12 months prior to index PCI procedure
* Treated with a bioresorbable scaffold 3 years before index PCI procedure
* Cardiogenic shock at index procedure
* Active SARS-CoV-2 infection or suspicion of SARS-CoV-2 infection
* Cannot provide written informed consent
* Under judicial protection, tutorship or curatorship
* Unable to understand and follow study-related instructions or unable to comply with study protocol
* Active bleeding requiring medical attention (BARC≥2) at index PCI
* Life expectancy less than one year
* Known hypersensitivity or allergy for aspirin, clopidogrel, ticagrelor, prasugrel, cobalt chromium or sirolimus
* Any anticipated PCI after index PCI, unless planned and scheduled at index PCI
* Participation in another stent or drug trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04500912
Study Brief:
Protocol Section:
NCT04500912