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Coronary Artery DiseaseExPENDNCT02496169

Prospective multicEntric NonranDomized Registry

A study testing eucaLimus in people with Coronary Artery Disease, run by Eucatech AG.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
eucaLimus
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
No sites listed yet
Study dates
Jul 2015to Dec 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

No sites are listed yet.

Michael Giese, Dr. contact

+49 7623 7177 ext. 103

clinicaltrial@eucatech.de

Alexander Karl, Dipl.-Ing. contact

+49 7623 7177 ext. 140

clinicaltrial@eucatech.de

About this study

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

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.

Being tested
eucaLimus
Keywords
PTCA, stenosis, sirolimus, stent
Medical subject headings
Coronary Artery Disease, Constriction, Pathologic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • eucaLimusDevice

    Percutaneous Coronary Intervention (PCI)

Study groups in NCT02496169
Study groupRoleWhat they receive
eucaLimusExperimentalPercutaneous Coronary Intervention (PCI)
Receives: Device: eucaLimus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Target Lumen Revascularisation (TLR)

    Clinical driven TLR

    Measured: 12 months post procedure

Secondary outcomes (4)

  1. Target Lumen Revascularisation (TLR)

    Clinical driven TLR

    Measured: 1 month, 6 months, 24 months post procedure

  2. Composite of cardiac death

    MI attributed to the target vessel and clinically driven target lesion revascularization

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

  3. Composite of all-cause mortality

    any MI and any revascularization, target vessel revascularization or revascularization of nontarget vessels

    Measured: 24 months post procedure

  4. Stent thrombosis

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2015 (estimated)
  2. Study startJul 2015
  3. Primary completionDec 2016 (estimated)
  4. Study completionDec 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02496169
Sponsor's protocol ID
eucaLimus2015
Acronym
ExPEND
Status last verified
Jul 2015
First submitted
2 Jul 2015
Last updated
14 Jul 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing eucaLimus in people with Coronary Artery Disease, run by Eucatech AG.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Michael Giese, Dr. (+49 7623 7177 ext. 103, clinicaltrial@eucatech.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Target Lumen Revascularisation (TLR) (time frame: 12 months post procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02496169.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2015.

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Prospective multicEntric NonranDomized Registry | AzTrials