Phase
Condition
Coronary Artery Disease
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Clinical indication, evidenced by angina / angina-equivalent symptoms or documentedischemia (non-invasive imaging such as scintigraphy, stress-MRI or stress-echo; FFR oriwFR) or patients with acute coronary syndromes (NSTE-ACS).
- Clinical indication to perform double stenting only with Synergy™ stents for aclinically significant bifurcation stenosis as judged by the operator.
- De-novo non-Ieft main coronary bifurcation lesions - 1,1,1 or 0,1,1 according to theMedina classification - of a native coronary artery with the following referencevessel diameters: main branch > 2,5 mm; side branch > 2,25 mm. The difference betweenvessel diameter of the main and side branch is ≤ 1 mm.
- The target lesion has not been previously treated with any interventional procedure.
- The target vessel (main branch and side branch) must appear feasible for stentimplantation.
- Patient has no other coronary intervention planned within 30 days of the procedure.
- Patient has been informed of the nature of the study and agrees to its provisions andhas written informed consent as approved by the Ethics Committee.
- Patient is willing to comply with all required post-procedure follow-up.
Exclusion
Exclusion Criteria:
- Patient had an acute ST-elevation myocardial infarction within 72 h preceding theindex procedure or target vessel contains intraluminal thrombus.
- Use of any other coronary stent than Synergy™ and Synergy Megatron™ except forbaiI-out situations.
- Patient with a known hypersensitivity or contraindication to the needed antithrombotictherapy, stent type or contrast media that cannot be adequately pre-medicated.
- Non successful treatment of other lesion during the same procedure.
- Patient with a severe bleeding diathesis, history of recent major bleeding or stroke (≤ 6 months), coagulopathy or severe liver disease.
- Patient has a co-morbidity (i.e. cancer) that may cause the patient to be noncompliantwith the protocol, or is associated with limited life-expectancy (Iess than 1 year).
- Patient is participating in any other clinical study with an investigational product.
- Patient is known to be pregnant or lactating at time of inclusion.
Study Design
Study Description
Connect with a study center
University Heart Center Freiburg • Bad Krozingen
Bad Krozingen, Suedring 15 79189
GermanyActive - Recruiting
Herz-u. Diabeteszentrum
Bad Oeynhausen, 32545
GermanyActive - Recruiting
Herz-und Gefäßzentrum
Bad Segeberg, 23795
GermanyActive - Recruiting
St. Johannes-Hospital
Dortmund, 44137
GermanyActive - Recruiting
Herzzentrum Dresden an der Technischen Universität
Dresden, 01307
GermanyActive - Recruiting
Elisabeth Krankenhaus
Essen, 45138
GermanyActive - Recruiting
Universitätsklinikum Freiburg/UHZ
Freiburg, 79110
GermanySite Not Available
Universitätsklinikum Gießen
Gießen, 35392
GermanyActive - Recruiting
Universitätsklinikum Leipzig
Leipzig, 04103
GermanyActive - Recruiting
Universitätsklinik Mannheim
Mannheim, 68167
GermanyActive - Recruiting
Deutsches Herzzentrum
München, 80636
GermanyActive - Recruiting
Klinikum Oldenburg
Oldenburg, 26133
GermanyActive - Recruiting
Herzzentrum Trier
Trier, 54292
GermanyActive - Recruiting
Universitätsklinikum Ulm
Ulm, 89070
GermanyActive - Recruiting

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