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:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2025-12-24 @ 6:56 PM
NCT ID:
NCT02060357
Eligibility Criteria:
Inclusion Criteria:
* Known to have diabetes
* Scheduled for percutaneous coronary intervention (PCI) with a stenosis suitable for DES implantation and OCT imaging
* Reference vessel diameter over 2.5mm by operator assessment.
* Able to understand and sign the written Informed Consent Form.
* Able and willing to follow the Protocol requirements.
Exclusion Criteria:
* Inability to consent
* Cardiogenic shock
* Planned use of a bare metal stent
* LMS coronary artery disease
* Congestive cardiac failure or low ejection fraction (LVEF \<35%)
* Lesions unsuitable for OCT
* Total length of stented lesion greater than 55mm (total combination of stent lengths)
* Age less than 18 years or age greater than 80 years
* Planned surgical procedure ≤ 12 months post PCI procedure
* Patient demonstrates evidence of thrombocytopenia (platelet count \< 100,000/mm3)
* Patients with contraindications to ASA, clopidogrel, or prasogrel
* Patient is currently on warfarin, or possibility of treatment with warfarin during the following 12 months post index procedure
* Allergy to contrast
* Patients enrolled in another active clinical trial.
* Potential for non-compliance towards the requirements in the study protocol.
* Serious known concomitant disease with a life expectancy of less than one year
* Follow-up impossible (no fixed abode, etc)
* Patients with renal impairment (Creatinine \>200mmol/L)
* Subjects of childbearing potential
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02060357
Study Brief:
Protocol Section:
NCT02060357