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Coronary Artery DiseasePhase 3PILOT-SECRETNCT02076516

Pilot Evaluation Of CORACTO® (THE PILOT-SECRET TRIAL)

A Phase 3 study testing Drug-eluting stent: CORACTO® in people with Coronary Artery Disease, run by Alvimedica at 5 sites in 4 countries.

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 The sponsor has not verified this record for over two years, so it may be out of date.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 effectiveness of the CORACTO® (Rapamycin®-Eluting coronary stent delivery system) for the treatment of up to two de novo lesions or restenotic post-PTCA (non-stented) lesions located in up to two epicardial native coronary arteries (maximum one lesion per vessel)… 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?
Drug-eluting stent: CORACTO®
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
5 sitesin 4 countries
Study dates
Oct 2013to May 2015
Phase
Phase 3
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 ≥ 18 years old.
  • Patient is eligible for percutaneous coronary intervention (PCI) and acceptable candidate for coronary artery bypass grafting (CABG).
  • Clinical evidence of ischemic heart disease and/or a positive functional study, stable angina pectoris (Canadian Cardiovascular Society Classification (CCS) 1, 2, 3 or 4) or unstable angina pectoris (Braunwald Class IB-C, IIB-C, or IIIB-C), or silent ischemia.
  • The target lesion(s) or target vessel(s) meet(s) all the following criteria:
  • The target lesion is a single de novo lesion in a native coronary artery.
  • The stenosis of target lesion(s) is ≥ 50% and < 100% (by visual estimation).
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  • The target lesion length must be ≤ 15 mm. In case that a second stent should be required for successful treatment, it should be a CORACTO® stent.
  • The target reference vessel diameter must be (by visual estimation) suitable for treatment with stents between 2.5 and 4.0 mm.
  • Patient has been informed of the nature of the study, understands the study requirements, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site.
  • The patient is willing and able to comply with all specified follow-up evaluations.

Who cannot join

  • Most recent left ventricular ejection fraction (LVEF) of the patient is < 25%.
  • Known allergies to the following: aspirin, Clopidogrel bisulfate (Plavix®), Prasugrel (Effient®) or Ticlopidine (Ticlid®), heparin, Rapamycin, stainless steel, Poly Lactic - co- glycolic acid or contrast agent (that cannot be adequately premedicated).
  • Platelet count is less than 100,000 cells/mm3 or more than 700,000 cells/mm3.
  • White Blood Cell count is less than 3,500 cells/mm3.
  • Evidence of an ST-segment elevation acute myocardial infarction (MI) or non-ST segment elevation MI with positive Troponin within 72 hours before the intended treatment.
  • ANY previous PCI
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  • Planned staged procedures (patient with 2-vessel disease should be treated during the same procedure). Presence of any other significant lesion of > 50% stenosis (by visual estimation) anywhere within the target vessel
  • Significant lesions in any non-target vessel that will require interventional treatment within 30 days post-procedure
  • Planned future interventional procedure in the target vessel .
  • The target lesion(s) require(s) treatment with a device other than PTCA balloon prior to stent placement. (e.g. but not limited to directional coronary atherectomy, excimer laser, rotational atherectomy, thrombus aspiration etc.).
  • Previous stenting anywhere within the target vessel(s)
  • Target vessel has evidence of thrombus
  • Excessive tortuosity (> 60°) of the target vessel proximal to the target lesion (by visual estimation).
  • The target lesion(s) has any of the following characteristics (by visual estimation):
  • Ostial or bifurcation lesion (within 3mm from region of origin of target vessel, by visual estimation).
  • Target lesion involves a side branch > 2mm in diameter.
  • Moderate to severely calcified lesion which cannot be successfully predilated.
  • Target lesion is located in or supplied by an arterial or venous bypass graft.
  • A complete occlusion (TIMI flow 0 or 1).
  • Target lesion is located in left main trunk.
  • Stroke or transient ischemic attack within 180 days prior to the baseline procedure.
  • Active peptic ulcer or upper GI bleeding within 180 days prior to the baseline procedure.
  • The patient has bleeding haemorrhagic diathesis or coagulopathy.
  • The patient will refuse a blood transfusion.
  • The patient has a widespread peripheral vascular disease.
  • Acute or chronic renal dysfunction (creatinine clearance below 40ml/m2).
  • The patient requires multiple stent implantations for a tandem lesion.
  • Life expectancy less than 1 year.
  • 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.
  • 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.
  • Female of childbearing potential, pregnant and breastfeeding women.

Trial locations and contacts

5 sites in 4 countries.

Javier Escaned, MD contact

escaned@secardiologia.es

5 sites in 4 countries

France2 sites, 2 recruiting

  • Groupe Hospitalier Mutualiste de Grenoble

    Grenoble, 38028

    Benjamin Faurie, MD, faurieb@gmail.com

    Benjamin Faurie, MD

    Recruiting

  • Hospital Prive Jacques Cartier

    Massy, 91300

    Yves Louvard, MD, y.louvard@icps.fr

    Yves Louvard

    Recruiting

Other trials in France

Belgium1 site, 1 recruiting

  • ZNA Middleheim

    Antwerp, 2020

    Stefan Verheye, MD, stefan.verheye@gmail.com

    Stefan Verheye, MD

    Recruiting

Other trials in Belgium

Spain1 site, 1 recruiting

  • Hospital Clínico San Carlos

    Madrid, 28040

    Sara Fernández, BSc/MSc, javier.escaned@salud.madrid.org

    Javier Escaned

    Recruiting

Other trials in Spain

Turkey (Türkiye)1 site, 1 recruiting

  • Bezmialem University Hospital

    Istanbul, 34093

    Omer Goktekin, Prof Dr, ogoktekin@ogu.edu.tr

    Omer Goktekin, Prof Dr

    Not yet recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Pilot Evaluation Of CORACTO® (Rapamycin-Eluting Coronary Stent Delivery System) in The Treatment Of Patients With Coronary Artery Disease

The purpose of this study is to evaluate the safety and effectiveness of the CORACTO® (Rapamycin®-Eluting coronary stent delivery system) for the treatment of up to two de novo lesions or restenotic post-PTCA (non-stented) lesions located in up to two epicardial native coronary arteries (maximum one lesion per vessel) suitable for treatment with stents from 2.5 to 4.0 mm in diameter < than 15 mm suitable for treatment with a single CORACTO® stent in a population of 100 patients.

Being tested
Drug-eluting stent: CORACTO®
Keywords
Drug-eluting Stent,Coronary Artery Disease
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.

  • Drug-eluting stent: CORACTO®Device

Study groups in NCT02076516
Study groupRoleWhat they receive
Drug-eluting stent: CORACTO®ExperimentalSingle arrm
Receives: Device: Drug-eluting stent: CORACTO®

What is being measured

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

  1. In-stent late loss (LL) in patients implanted with a CORACTO® stent (per protocol analysis)

    Measured: at 6 months

Secondary outcomes (1)

  1. Stent Thrombosis ( Definite and probable)

    Measured: at 30 days, 6 months 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 posted3 Mar 2014 (estimated)
  2. Study startOct 2013
  3. Primary completionOct 2014 (estimated)
  4. Study completionMay 2015 (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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02076516
Sponsor's protocol ID
ALV-01
Acronym
PILOT-SECRET
Status last verified
Feb 2014
First submitted
28 Feb 2014
Last updated
3 Mar 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Drug-eluting stent: CORACTO® in people with Coronary Artery Disease, run by Alvimedica at 5 sites in 4 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 10 inclusion and 31 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 3 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in France, Belgium, Spain, Turkey (Türkiye). 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Javier Escaned, MD (escaned@secardiologia.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In-stent late loss (LL) in patients implanted with a CORACTO® stent (per protocol analysis) (time frame: at 6 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 NCT02076516.

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 3 Mar 2014; AzTrials last refreshed its copy on 6 Nov 2026.

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