Prospective multicEntric NonranDomized Registry

NCT02496169 | Unknown DMC

• 1 other identifier: eucaLimus2015
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Artery Disease

Keywords

PTCA; stenosis; sirolimus; stent

Outcome Measures

Primary Outcomes (1)

• Target Lumen Revascularisation (TLR)

  Clinical driven TLR

  12 months post procedure

Secondary Outcomes (4)

• Target Lumen Revascularisation (TLR)

  1 month, 6 months, 24 months post procedure

• Composite of cardiac death

  1 month, 6 months, 12 months, 24 months post procedure

• Composite of all-cause mortality

  24 months post procedure

• Stent thrombosis

  1 month, 6 months, 12 months, 24 months post procedure

Study Arms (1)

eucaLimus

EXPERIMENTAL

Percutaneous Coronary Intervention (PCI)

Device: eucaLimus

Interventions

eucaLimus DEVICE

Percutaneous Coronary Intervention (PCI)

eucaLimus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Target lesion must be in major coronary artery or branch (target vessel).
• Target lesion must have angiographic evidence of ≥ 50% and \< 100% stenosis (by operator visual estimate)
• Target lesion must be ≤ 35 mm in length by operator visual estimate.
• Target vessel Reference Vessel Diameter (RVD) of 2.25mm - 4.00mm by operator visual estimate.
• Target lesion must be treatable with a maximum of 1 stents

You may not qualify if:

• 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 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.
• Subject has documented left ventricular ejection fraction (LVEF) \< 30% within 90 days prior to the index procedure.
• Subject is dialysis-dependent.
• Subject has impaired renal function (i.e., blood creatinine \> 2.5 mg/dL or 221 μmol/L determined within 7 days prior to the index procedure).
• Subject has leukopenia (i.e. \< 3,000 white blood cells/mm3), thrombocytopenia (i.e. \< 100,000 platelets/mm3) or thrombocytosis (i.e. \> 700,000 platelet/mm3).
• Subject is receiving oral or intravenous immunosuppressive therapy (inhaled steroids are permitted), or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus; diabetes mellitus is permitted).
• Subject is receiving chronic anticoagulation (e.g. coumadin, dabigatran, apixaban, rivaroxaban or any other agent).

Sponsors & Collaborators

• Eucatech AG: lead
• CERES GmbH: collaborator

MeSH Terms

Conditions

Coronary Artery Disease; Constriction, Pathologic

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean-Marc Pernes, Dr.

  Hôpital privé d' Antony 1 rue Velpeau 92160 Antony, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Giese, Dr.

CONTACT

+49 7623 7177; clinicaltrial@eucatech.de

Alexander Karl, Dipl.-Ing.

CONTACT

+49 7623 7177; clinicaltrial@eucatech.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2015
• First Posted: July 14, 2015
• Study Start: July 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: July 14, 2015

Record last verified: 2015-07