Status:
COMPLETED
Registry of RESOLUTE-ONYX™ Zotarolimus-eluting Stent Utilization in Percutaneous Small Vessel Coronary Interventionism.
Lead Sponsor:
Fundación Investigación Sanitaria en León
Conditions:
Coronary Disease
Angina, Stable
Eligibility:
All Genders
18+ years
Brief Summary
DESIGN: Prospective, single-arm, multicenter, observational, prospective registry of the use of the RESOLUTE-ONYX™ zotarolimus-eluting stent in percutaneous coronary intervention in small vessels. Cl...
Detailed Description
1.1 STUDY TITLE: Prospective, single-arm, multicenter, observational, prospective registry of use of the RESOLUTE-ONYX™ zotarolimus-eluting stent in percutaneous small vessel coronary intervention (D...
Eligibility Criteria
Inclusion
- Signature of the Informed Consent in writing.
- Patients over 18 years of age.
- Males or post-menopausal women or women under contraceptive treatment. Women of childbearing age must have a negative pregnancy test.
- Diagnosis of stable angina, silent ischemia or non-ST-segment elevation acute coronary syndrome (unstable angina or non-Q infarction).
- De novo coronary artery disease, single-vessel or multivessel, with stenosis \>70% according to visual estimation, susceptible to treatment with intracoronary stenting.
- Coronary stenosis involving a vessel with diameter ≥2 mm and ≤2.5 mm.
- Implantation of the RESOLUTE-ONYX™ zotarolimus-eluting stent used according to the indications for use in routine clinical practice at the center.
Exclusion
- Acute myocardial infarction with ST-segment elevation during the hospitalization in which the patient is included.
- Significant stenosis of the left coronary artery trunk.
- In-stent restenosis.
- Chronic total occlusion.
- Stenosis in aorto-coronary grafts of saphenous vein or mammary or radial artery.
- Hemorrhagic diathesis or high risk of bleeding.
- Treatment with oral anticoagulants.
- Allergy to aspirin, clopidogrel, prasugrel or ticagrelor.
- Known allergy to zotarolimus, nickel, chromium, or cobalt.
- Women who are pregnant, breastfeeding or expect to become pregnant within the next year.
- Participation in another clinical study.
- Limited life expectancy (\< 1 year).
- Planned major elective surgery
- Unable to complete follow-up.
Key Trial Info
Start Date :
October 18 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 17 2020
Estimated Enrollment :
307 Patients enrolled
Trial Details
Trial ID
NCT04785846
Start Date
October 18 2017
End Date
February 17 2020
Last Update
March 10 2021
Active Locations (15)
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1
University Hospital of Santiago de Compostela
Santiago de Compostela, A Coruña, Spain, 15706
2
University Hospital of Cruces
Barakaldo, Bizkaia, Spain, 48903
3
University Hospital Marqués de Valdecilla
Santander, Cantabria, Spain, 39008
4
University Hospital San Pedro
Logroño, La Rioja, Spain, 26006