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 @ 7:36 PM
Ignite Modification Date:
2025-12-24 @ 7:36 PM
NCT ID:
NCT01465503
Eligibility Criteria:
Inclusion Criteria:
* • Male or female able to understand and sign a witnessed informed consent
* Age ≥ 18 ys
* Patients with stable (CCS 1-4) or unstable angina pectoris (but with the most recent anginal episode occurring \>48 hours before the procedure) or documented silent ischemia
* Stable Hemodynamic conditions (systolic BP \> 100 HR \> 40 \< 100).
* No clinical and ECG changes suggestive of ongoing acute or recent (\<48 hours) myocardial infarction.
* Bleeding risk score ≥ 10
* Procedure planned via femoral approach
* Double antiplatelet therapy.
4.2.2 Angiographic inclusion criteria
• Angiographic evidence of a de novo lesion \> 50% requiring intervention
Exclusion Criteria:
* • Female sex with childbearing potential
* Age \<18 years
* Ongoing or recent episode (\<48 hours) of unstable coronary artery disease (including both ST-elevation and non-ST-elevation acute coronary syndromes)
* Chronic kidney disease (estimated glomerular filtration rate \<30mL/min/1.73 m2).
* Ongoing serious bleeding or bleeding diathesis
* Previous stroke in the last 6 months
* Platelet count ≤100,00 per mm3
* History of heparin- induced-thrombocytopenia
* Known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, or sensitivity to contrast which cannot be adequately pre-medicated.
* Hemodynamic instability (systolic blood pressure \< 100 mm Hg; heart rate \< 40 bpm or \>100 bpm; complex ventricular arrhythmias; AV block) requiring balloon counterpulsation or inotropic support.
* The patient is simultaneously participating in another device or drug study. Patient must have completed the follow-up phase of any previous study at least 30 days prior to enrolment in this study.
* Positive clinical history for intracranial neoplasia, AV malformation, aneurysm.
* INR ≥ 2.0 or prothrombin time 1.2 times upper limit of normality
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01465503
Study Brief:
Protocol Section:
NCT01465503