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Coronary Artery DiseaseNCT02009956

EXCELLA Post-Approval Study

A study testing Subjects receiving DESyne Novolimus Eluting CSS in people with Coronary Artery Disease, run by Elixir Medical Corporation at 4 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To evaluate long-term safety and performance of the DESyne Novolimus Eluting Coronary Stent System and the DESyne BD Novolimus Eluting Coronary Stent System 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?
Subjects receiving DESyne Novolimus Eluting CSS
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
4 sitesin 3 countries
Study dates
26 Feb 2014to 1 Jun 2016
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

  • The patient must be ≥18 years of age.
  • The patient must have angina pectoris as defined by the Canadian Cardiovascular Society Classification, documented silent ischemia, or a positive functional study.
  • The patient has a planned intervention of up to two lesions each coverable by a single stent located in separate major epicardial territories. Each lesion/vessel must meet the following criteria:
  • De novo lesion
  • The target lesion reference site must be visually estimated to be ≥ 2.5 mm and ≤ 4.0 mm in diameter.
  • The target vessel must be a major coronary artery or major branch with a visually estimated stenosis of ≥ 50% and <100%.
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  • The visually estimated target lesion length must be ≤ 34 mm (DESyne Novolimus Eluting CSS) (Arm A)*.
  • The visually estimated target lesion length must be ≤ 34 mm (DESyne BD Novolimus Eluting CSS) (Arm B)*
  • ≥ TIMI 1 coronary flow.
  • Subject to commercial availability of product sizes in the specific region/country.
  • The patient must be an acceptable candidate for coronary artery bypass surgery.
  • Female subjects of childbearing potential must have a negative pregnancy test within seven (7) days before the procedure and must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure.
  • The patient and the patient's physician agree to the follow-up schedule.
  • The patient or guardian who has been informed of the nature of the study agrees to its provisions and has provided written informed consent, approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Who cannot join

  • The patient has a known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, mTOR inhibitor class drugs, cobalt chromium alloy, methacrylate or polylactide polymer, or sensitivity to contrast which cannot be adequately premedicated.
  • The patient is a female, intending to get pregnant within the next year.
  • Target vessel(s) require a staged procedure post index hospitalization discharge through 9 months of this index procedure.
  • There will be an untreated significant lesion of > 40% diameter stenosis remaining proximal or distal to the target site after the planned intervention.
  • Previous placement of a stent within 10 mm of the target lesion.
  • Total occlusion or TIMI 0 coronary flow in the target vessel.
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  • Restenosis lesion
  • The proximal target vessel or target lesion is severely calcified by visual assessment.
  • Aorto-ostial location, unprotected left main lesion location, or a lesion within 5 mm of the origin of the LAD or LCX.
  • Lesion involvement of a significant side branch (branch diameter > 2 mm) that would be covered by stenting.
  • High probability that treatment other than PTCA or stenting will be required for treatment of the same lesion.
  • The patient has suffered a myocardial infarction within the past 72 hours and the CK or CK-MB has not returned to normal at the time of the index procedure.
  • The patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
  • The patient suffered a stroke, transient ischemic neurological attack (TIA) or significant gastrointestinal (GI) bleed within the past six months.
  • The patient has renal insufficiency as determined by a creatinine of > 2.0 mg/dl.
  • The target lesion, or the target vessel proximal to the target lesion, contains thrombus.
  • Documented left ventricular ejection fraction of ≤ 25%.
  • The patient is a recipient of a heart transplant.
  • The patient has extensive peripheral vascular disease that precludes safe sheath insertion or extreme anti-coagulation.
  • The patient has other medical illness (i.e., cancer or congestive heart failure) that may cause the patient to be non-compliant with the protocol, confound the data interpretation or is associated withlimited life expectancy (i.e., less than one year).
  • The patient is simultaneously participating in another investigational device or drug study. Patient must have completed the primary follow-up phase of any previous study. Trials with extended follow-up phases of now commercially available products are not considered investigational studies. Patients may be enrolled one time only in this trial.
  • Patients who are unable or unwilling to cooperate with study procedures.

Trial locations and contacts

4 sites in 3 countries.

4 sites in 3 countries

Jordan2 sites

  • Jordan Hospital

    Amman, 11152

  • King Abdullah University Hospital

    Irbid, 22110

Other trials in Jordan

Germany1 site

  • Krankenhaus der Barmherzigen Brüder

    Trier, 54292

Other trials in Germany

Spain1 site

  • Santiago de Compostela University Hospital Complex

    Santiago de Compostela, 15706

Other trials in Spain

About this study

Official title: POST MARKETING STUDY OF THE ELIXIR DESyne® NOVOLIMUS ELUTING CORONARY STENT SYSTEM AND THE DESyne® BD NOVOLIMUS ELUTING CORONARY STENT SYSTEM IN THE TREATMENT OF PATIENTS WITH DE NOVO NATIVE CORONARY ARTERY LESIONS

To evaluate long-term safety and performance of the DESyne Novolimus Eluting Coronary Stent System and the DESyne BD Novolimus Eluting Coronary Stent System

Read the detailed description

DESyne and DESyne BD are not currently approved for sale in the United States.

Being tested
Subjects receiving DESyne Novolimus Eluting CSS
Medical subject headings
Coronary Artery Disease

What participants receive

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

  • Subjects receiving DESyne Novolimus Eluting CSSDevice

Study groups in NCT02009956
Study groupRoleWhat they receive
DESyne Novolimus Eluting CSSOtherEnrollment of up to 50 patients with up to two de novo native coronary artery lesions measuring between 2.5 and 4.0 mm in diameter and </= 34 mm in length receiving the DESyne Novolimus Eluting CSS.
Receives: Device: Subjects receiving DESyne Novolimus Eluting CSS

What is being measured

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

  1. Device-oriented Composite Endpoint (DoCE)

    Device-oriented Composite Endpoint (DoCE) at 1, 9, 12, and 24 months. DoCE is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization.

    Measured: 1, 9, 12, and 24 months

Timeline

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

  1. First posted12 Dec 2013 (estimated)
  2. Study start26 Feb 2014
  3. Primary completion2 Mar 2015
  4. Study completion1 Jun 2016

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02009956
Sponsor's protocol ID
ELX-CL-1004
Status last verified
Apr 2021
First submitted
6 Dec 2013
Last updated
26 Apr 2021
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Subjects receiving DESyne Novolimus Eluting CSS in people with Coronary Artery Disease, run by Elixir Medical Corporation at 4 sites in 3 countries.

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 14 inclusion and 22 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: finished, as of the sponsor's last update on 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Jordan, Germany, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Device-oriented Composite Endpoint (DoCE) (time frame: 1, 9, 12, and 24 months). 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 NCT02009956.

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 26 Apr 2021.

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