A Prospective, Multi-centric, Nonrandomised Interventional Study of a Sirolimus-eluting Stent With a Biodegradable Polymer for Percutaneous Coronary Revascularization

Eucatech AG0 sites400 target enrollmentJuly 2015

ConditionsCoronary Artery Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Eucatech AG
Enrollment: 400
Primary Endpoint: Target Lumen Revascularisation (TLR)
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of the eucaLimus Sirolimus Eluting stent system in patients with de novo coronary lesions.

Registry

clinicaltrials.gov

Start Date

July 2015

End Date

December 2017

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Eucatech AG

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject is ≥18 years or the minimum age required for legal adult consent in the country of enrollment.
•Subject is an acceptable candidate for Percutaneous Coronary Intervention (PCI).
•Subject is an acceptable candidate for Emergent Coronary Artery Bypass Grafting (CABG).
•Subject has clinical evidence of ischemic heart disease, stable or unstable angina pectoris or documented silent ischemia.
•Subject is eligible for dual anti-platelet therapy treatment with aspirin plus either clopidogrel, prasugrel, ticagrelor or ticlopidine.
•Subject has provided written informed consent.
•Subject is willing to comply with study follow-up requirements.
•Each target lesion/vessel must meet all of the following angiographic criteria for the subject to be eligible for the trial:
•Subject has up to 3 target lesions in up to 3 separate target vessels Subject has up to 3 target lesions in in up 2 separate target vessels (2 target lesions in 1 vessel and 1 target lesion in a separate vessel). Subject has 1 target lesions in 1 vessel.
•Target lesion must be de novo.

Exclusion Criteria

•Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation myocardial infarction (STEMI) within 72 hours prior to the index procedure. Hemodynamically stable non-STEMI (NSTEMI) subjects are eligible for study enrollment.
•Subject is presenting cardiogenic shock.
•Subject is pregnant and/or breastfeeding or intends to become pregnant during the duration of the study.
•Subject has a known allergy to contrast medium that cannot be adequately pre-medicated, or any known allergy to thienopyridine, aspirin, both heparin and bivalirudin, L-605 cobalt-chromium (Co-Cr) alloy or one of its major elements (cobalt, chromium, tungsten and nickel), Polylactic-Co-Glycolic Acid (PLGA), sirolimus
•Revascularization of any target vessel within 9 months prior to the index procedure or previous PCI of any non-target vessel within 30 days prior to the index procedure.
•Planned treatment of a lesion not meeting angiographic inclusion and exclusion criteria during the index procedure or after the index procedure.
•Planned surgery within 6 months of index procedure unless dual antiplatelet therapy can be maintained throughout the peri-surgical period.
•History of a stroke or transient ischemic attack (TIA) within 6 months prior to the index procedure.
•Subjects with active bleeding disorders, active coagulopathy, or any other reason, who are ineligible for Dual Antiplatelet Therapy (DAPT).
•Subject will refuse blood transfusions.

Outcomes

Primary Outcomes

Target Lumen Revascularisation (TLR)

Time Frame: 12 months post procedure

Clinical driven TLR

Secondary Outcomes

Stent thrombosis(1 month, 6 months, 12 months, 24 months post procedure)
Target Lumen Revascularisation (TLR)(1 month, 6 months, 24 months post procedure)
Composite of all-cause mortality(24 months post procedure)
Composite of cardiac death(1 month, 6 months, 12 months, 24 months post procedure)