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Coronary Artery DiseaseDISCOVERY123NCT01844843

Optical Frequency Domain Imaging (OFDI) Assessed Strut Coverage of New Terumo DES

A study testing TCD-10023 drug eluting stent in people with Coronary Artery Disease, run by Terumo Europe N.V. at 6 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

Purpose of this study is to evaluate, after implantation of a drug eluting stent (DES), coverage of the stent struts by new tissue. The evaluation will be performed by means of intravascular imaging technology (optical frequency domain imaging, OFDI). 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?
TCD-10023 drug eluting stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
6 sitesin 3 countries
Study dates
Jan 2014to 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

  • Patient is at least 18 years old
  • Patients is a suitable candidate for Percutaneous Coronary Intervention (PCI)
  • Patient has multi-vessel disease with ≥2 de-novo lesions in native coronary arteries suitable for treatment with TCD-10023 DES
  • Target lesions are suitable for OFDI examination;
  • Patient requires staged procedure between 3-5 weeks after baseline procedure, according to investigator's judgement
  • Target vessel reference diameter is between 2.5 - 4.0 mm (visual assessment)
  • Patient has provided written informed consent
  • Patient is affiliated to social security or equivalent system (France only)

Who cannot join

  • - Patient has known allergy to sirolimus, cobalt, chromium, nickel, or contrast agent (that cannot be adequately premedicated)
  • Patient is not a suitable candidate for use of Dual Anti-Platelet Therapy (DAPT) because of active or recent bleedings or for use of vitamin K antagonist, like warfarin, dabigatran, rivaroxaban or acenocoumarol;
  • Patient is presenting with ST-segment elevated MI (STEMI) at baseline procedure
  • Patient has Killip-class > 1 at admission
  • Patient is in cardiogenic shock
  • Patient is a female of childbearing potential
Show all 17Show fewer
  • Patient has life expectancy of less then 1 year
  • Patient is expected to undergo major surgery within 3 months
  • Patient has Left Main disease ≥ 50%
  • Target lesion at bifurcation requiring 2 stents technique
  • Target lesions are severely calcified
  • Target lesion is located within 3 mm of aorta-ostium
  • Patient has renal failure defined as estimated Glomerular Filtration Rate (eGFR) <50 mL/min/1.73m²
  • Target lesions require preparation other than balloon pre-dilatation
  • Patient is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints; Note: Trials requiring extended follow-up for products that were investigational, but have become commercially available since then, are not considered investigational trials
  • In the Investigator's opinion patient has (a) co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study
  • Patient is under judicial protection (France only)

Trial locations and contacts

6 sites in 3 countries.

6 sites in 3 countries

Netherlands3 sites

  • MCL

    Leeuwarden, 8934 ad

  • Erasmus

    Rotterdam, 3015 CE

  • Maasstadziekenhuis

    Rotterdam

Other trials in Netherlands

France2 sites

  • Cardiovascular Institute Paris Sud (ICPS)

    Massy, 91300

  • CHU Rangueil

    Toulouse, 31059

Other trials in France

Germany1 site

  • LMU

    München, 81377

Other trials in Germany

About this study

Official title: Evaluation With OFDI of Strut Coverage of Terumo New Drug Eluting Stent (Development Code TCD-10023) With Biodegradable Polymer at 1, 2 and 3 Months

Purpose of this study is to evaluate, after implantation of a drug eluting stent (DES), coverage of the stent struts by new tissue. The evaluation will be performed by means of intravascular imaging technology (optical frequency domain imaging, OFDI). Renewed tissue coverage over the implanted stent struts prevents direct contact between blood and metal/polymer, which could lead to adverse events: patients need to take blood-thinning drugs to prevent these events. Ous new stent has drug and polymer only on the outside of the stent, and the polymer is degraded by the body leaving a bare metal stent after 3-4 months. This should allow fast coverage of the struts, and might allow to reduce duration of the supportive medical treatment. Our hypothesis is that <20% of the struts remain uncovered at 3 months after implantation, as assessed by OFDI.

Read the detailed description

We will enroll patients with multiple coronary lesions, which, as is routine practice, will be treated with the new DES in 2 sessions (second one approximately 3-5 weeks after the first one). We will assess lesions by OFDI after the implantation and at the time of 3 months follow-up, when we will ask patients to undergo a coronary angiography. Patients will then have a follow-up contact at 1 year after initial implantation.

Being tested
TCD-10023 drug eluting stent
Keywords
Drug eluting stents, coronary artery disease, Percutaneous Coronary Intervention, Tomography, Optical Coherence
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.

  • TCD-10023 drug eluting stentDevice

    Implantation of new drug eluting stent in coronary artery lesions

Study groups in NCT01844843
Study groupRoleWhat they receive
TCD-10023 drug eluting stentExperimentalAll patients will be treated with the new Drug eluting stent TCD-10023
Receives: Device: TCD-10023 drug eluting stent

What is being measured

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

  1. OFDI assessed percent stent strut coverage

    Measured: 3 months post procedure.

Secondary outcomes (14)

  1. % stent strut coverage

    Measured: at 1 and 2 months

  2. % stented lesions with >10% uncovered struts

    Measured: at 1, 2, 3 months

  3. % of stented lesions with >20% uncovered stent struts

    Measured: at 1, 2, 3 months

  4. % of acquired mal-apposed stent struts

    Measured: at 1, 2, 3 months

  5. amount (mm³) of in-stent intimal hyperplasia

    Measured: at 1, 2, 3 months

  6. amount (mm³)of in-segment hyperplasia

    Measured: at 1, 2, 3 months

  7. neo-intimal thickness (µm)

    Measured: at 1, 2, 3 months

  8. in-stent late lumen loss (mm) assessed by Quantitative Coronary Angiography (QCA)

    Measured: at 3 months

  9. In-segment late lumen loss (mm) assessed by QCA

    Measured: at 3 months

  10. Target Lesion revascularization (TLR)

    Measured: at 1, 3, 12 months

  11. Target Lesion Failure (TLF - composite of cardiac death, Myocardial infarction, TLR

    Measured: at 1, 3, 12 months

  12. Target Vessel Revascularization (TVR)

    Measured: at 1, 3, 12 months

  13. Major Cardiac Adverse Events (MACE) defined as cardiac death, Q wave and non-Q wave Myocardial Infarction (MI) , emergent coronary artery bypass surgery, or target vessel revascularization (TVR)

    Measured: at 1, 3, 12 months

  14. Stent thrombosis

    Measured: at 1, 3 and 12 months

Timeline

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

  1. First posted1 May 2013 (estimated)
  2. Study startJan 2014
  3. Primary completionJun 2016
  4. Study completionJun 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
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01844843
Sponsor's protocol ID
T121E4
Acronym
DISCOVERY123
Status last verified
Oct 2019
First submitted
29 Apr 2013
Last updated
8 Oct 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Chevalier B, Smits PC, Carrie D, Mehilli J, Van Boven AJ, Regar E, Sawaya FJ, Chamie D, Kraaijeveld AO, Hovasse T, Vlachojannis GJ. Serial Assessment of Strut Coverage of Biodegradable Polymer Drug-Eluting Stent at 1, 2, and 3 Months After Stent Implantation by Optical Frequency Domain Imaging: The DISCOVERY 1TO3 Study (Evaluation With OFDI of Strut Coverage of Terumo New Drug Eluting Stent With Biodegradable Polymer at 1, 2, and 3 Months). Circ Cardiovasc Interv. 2017 Dec;10(12):e004801. doi: 10.1161/CIRCINTERVENTIONS.116.004801.

    PubMed 29246909

Questions about this trial

What is this clinical trial studying?

A study testing TCD-10023 drug eluting stent in people with Coronary Artery Disease, run by Terumo Europe N.V. at 6 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 8 inclusion and 17 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 8 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Netherlands, France, Germany. 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?

OFDI assessed percent stent strut coverage (time frame: 3 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 NCT01844843, which also lists 1 linked publication.

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 8 Oct 2019.

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