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 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
NCT ID:
NCT04192760
Eligibility Criteria:
Inclusion Criteria:
1. Clinical indication, evidenced by angina / angina-equivalent symptoms or documented ischemia (non-invasive imaging such as scintigraphy, stress-MRI or stress-echo; FFR or iwFR) or patients with acute coronary syndromes (NSTE-ACS).
2. Clinical indication to perform double stenting only with Synergy™ stents for a clinically significant bifurcation stenosis as judged by the operator.
3. De-novo non-Ieft main coronary bifurcation lesions - 1,1,1 or 0,1,1 according to the Medina classification - of a native coronary artery with the following reference vessel diameters: main branch \> 2,5 mm; side branch \> 2,25 mm. The difference between vessel diameter of the main and side branch is ≤ 1 mm.
4. The target lesion has not been previously treated with any interventional procedure.
5. The target vessel (main branch and side branch) must appear feasible for stent implantation.
6. Patient has no other coronary intervention planned within 30 days of the procedure.
7. Patient has been informed of the nature of the study and agrees to its provisions and has written informed consent as approved by the Ethics Committee.
8. Patient is willing to comply with all required post-procedure follow-up.
Exclusion Criteria:
1. Patient had an acute ST-elevation myocardial infarction within 72 h preceding the index procedure or target vessel contains intraluminal thrombus.
2. Use of any other coronary stent than Synergy™ and Synergy Megatron™ except for baiI-out situations.
3. Patient with a known hypersensitivity or contraindication to the needed antithrombotic therapy, stent type or contrast media that cannot be adequately pre-medicated.
4. Non successful treatment of other lesion during the same procedure.
5. Patient with a severe bleeding diathesis, history of recent major bleeding or stroke (≤ 6 months), coagulopathy or severe liver disease.
6. Patient has a co-morbidity (i.e. cancer) that may cause the patient to be noncompliant with the protocol, or is associated with limited life-expectancy (Iess than 1 year).
7. Patient is participating in any other clinical study with an investigational product.
8. Patient is known to be pregnant or lactating at time of inclusion.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04192760
Study Brief:
Protocol Section:
NCT04192760