Prospective multicEntric NonranDomized Registry (ExPEND)
Primary Purpose
Coronary Artery Disease
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
eucaLimus
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring PTCA, stenosis, sirolimus, stent
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.
- 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
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.
- 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).
- Subject has life expectancy of < 1 year.
- Subject is participating in another investigational (medical device or drug) clinical study. Subjects may be concurrently enrolled in a study, as long as the study device, drug or protocol does not interfere with the investigational treatment or protocol of this study.
- In the investigator's opinion, subject will not be able to comply with the follow-up requirements.
Subjects will be excluded from the trial if any of the target lesions/vessels meets any of the following angiographic criteria:
- Target lesion is located within a saphenous vein graft or arterial graft.
- Target lesion involves a side branch of > 2.0 mm in diameter. Note: Lesions within 3 mm of the origin of the right coronary artery may be treated.
- Target vessel/lesion is excessively tortuous / angulated or is severely calcified, that would prevent complete inflation of an angioplasty balloon. This assessment should be based on visual estimation.
- Target vessel has angiographic evidence of thrombus.
- Target vessel was treated with brachytherapy any time prior to the index procedure.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
eucaLimus
Arm Description
Percutaneous Coronary Intervention (PCI)
Outcomes
Primary Outcome Measures
Target Lumen Revascularisation (TLR)
Clinical driven TLR
Secondary Outcome Measures
Target Lumen Revascularisation (TLR)
Clinical driven TLR
Composite of cardiac death
MI attributed to the target vessel and clinically driven target lesion revascularization
Composite of all-cause mortality
any MI and any revascularization, target vessel revascularization or revascularization of nontarget vessels
Stent thrombosis
Full Information
NCT ID
NCT02496169
First Posted
July 2, 2015
Last Updated
July 9, 2015
Sponsor
Eucatech AG
Collaborators
CERES GmbH
1. Study Identification
Unique Protocol Identification Number
NCT02496169
Brief Title
Prospective multicEntric NonranDomized Registry
Acronym
ExPEND
Official Title
A Prospective, Multi-centric, Nonrandomised Interventional Study of a Sirolimus-eluting Stent With a Biodegradable Polymer for Percutaneous Coronary Revascularization
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eucatech AG
Collaborators
CERES GmbH
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
PTCA, stenosis, sirolimus, stent
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
eucaLimus
Arm Type
Experimental
Arm Description
Percutaneous Coronary Intervention (PCI)
Intervention Type
Device
Intervention Name(s)
eucaLimus
Intervention Description
Percutaneous Coronary Intervention (PCI)
Primary Outcome Measure Information:
Title
Target Lumen Revascularisation (TLR)
Description
Clinical driven TLR
Time Frame
12 months post procedure
Secondary Outcome Measure Information:
Title
Target Lumen Revascularisation (TLR)
Description
Clinical driven TLR
Time Frame
1 month, 6 months, 24 months post procedure
Title
Composite of cardiac death
Description
MI attributed to the target vessel and clinically driven target lesion revascularization
Time Frame
1 month, 6 months, 12 months, 24 months post procedure
Title
Composite of all-cause mortality
Description
any MI and any revascularization, target vessel revascularization or revascularization of nontarget vessels
Time Frame
24 months post procedure
Title
Stent thrombosis
Time Frame
1 month, 6 months, 12 months, 24 months post procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
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
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.
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).
Subject has life expectancy of < 1 year.
Subject is participating in another investigational (medical device or drug) clinical study. Subjects may be concurrently enrolled in a study, as long as the study device, drug or protocol does not interfere with the investigational treatment or protocol of this study.
In the investigator's opinion, subject will not be able to comply with the follow-up requirements.
Subjects will be excluded from the trial if any of the target lesions/vessels meets any of the following angiographic criteria:
Target lesion is located within a saphenous vein graft or arterial graft.
Target lesion involves a side branch of > 2.0 mm in diameter. Note: Lesions within 3 mm of the origin of the right coronary artery may be treated.
Target vessel/lesion is excessively tortuous / angulated or is severely calcified, that would prevent complete inflation of an angioplasty balloon. This assessment should be based on visual estimation.
Target vessel has angiographic evidence of thrombus.
Target vessel was treated with brachytherapy any time prior to the index procedure.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Giese, Dr.
Phone
+49 7623 7177
Ext
103
Email
clinicaltrial@eucatech.de
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Karl, Dipl.-Ing.
Phone
+49 7623 7177
Ext
140
Email
clinicaltrial@eucatech.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Marc Pernes, Dr.
Organizational Affiliation
Hôpital privé d' Antony 1 rue Velpeau 92160 Antony, France
Official's Role
Principal Investigator
12. IPD Sharing Statement
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Prospective multicEntric NonranDomized Registry
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