AzTrials
AzTrials

Stable Coronary DiseaseBESTNCT01122719

Brazilian and Italian Evaluation of Safety Using Tacrolimus-eluting Stent With Short-term Dual Antiplatelet Regimen

A study testing Drug Eluting Stent in people with Stable Coronary Disease and Unstable Coronary Disease, run by CID - Carbostent & Implantable Devices at 2 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

To evaluate the safety and efficacy of the Janus OPTIMA Tacrolimus-Eluting Stent (Optima TES, CID) for the treatment of de novo coronary lesions when associated with short-term (two months) dual antiplatelet (aspirin + clopidogrel) regimen. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Drug Eluting Stent
Type of treatment
Medical device
How many people
16 participants
Where
2 sitesin 2 countries
Study dates
Oct 2010to Mar 2013
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 with >18 years of age;
  • Symptoms of stable or unstable angina and/or presence of a positive functional test for ischemia;
  • Presence of a single de novo target lesion located in a native coronary vessel suitable for percutaneous treatment with the study stents;
  • Acceptable candidate for coronary artery bypass graft(CABG)surgery;
  • The subject is willing to sign a written informed consent prior to procedure, and is willing to undergo ALL study protocol follow-ups,including angiographic, IVUS and OCT assessments.
  • Single, de novo lesion
Show all 10Show fewer
  • Target lesion located in a major epicardial coronary vessel with reference of 2.5-3.5mm in diameter (by on-line QCA)
  • Target lesions ≤19mm in length (by visual estimation) that can be treated (covered) by one single study stent (19 or 24mm in length);
  • ≥50% and <100% diameter stenosis;
  • TIMI (Thrombolysis In Myocardial Infarction) flow grade ≥2.

Who cannot join

  • Known hypersensitivity or contraindication to tacrolimus, heparin,any required medications including thienopyridines, and contrast media which cannot be adequately pre medicated;
  • Patient is a female with childbearing potential;
  • Pre-treatment of the target lesion with any devices other than balloon angioplasty;
  • Previous brachytherapy in the target vessel;
  • Presence of non-target vessel lesions which require staged procedure(s) <30 days of the index procedure;
  • Prior CABG surgery to target vessel;
Show all 37Show fewer
  • Previous percutaneous coronary intervention (PCI) or CABG surgery <30 days to the index procedure date;
  • Acute myocardial infarction <3 days, with cardiac enzyme elevation including total creatine kinase (CK) >2 times the upper normal limit value and/or CK-MB above the upper normal limit value within the past 72 hours;
  • CK and/or CK-MB levels elevated above the upper normal limit value at the time of the index procedure;
  • Documented left ventricular ejection fraction <30%;
  • Renal insufficiency determined by a baseline serum creatinine >2.0 mg/dl;
  • Thrombocytopenia with a baseline platelet count <100,000 cells/mm3;
  • Anemia with baseline hemoglobin <10g/dL;
  • Extensive peripheral vascular disease or extreme anticoagulation that precludes safe >5 French sheath insertion;
  • History of bleeding diathesis, coagulopathy, or refusal of blood transfusions;
  • Patients has suffered a stroke, transient ischemic attack (TIA),or cerebrovascular accident (CVA) within the past 6 months;
  • Significant gastrointestinal or genitourinary bleed within the past 6 months;
  • Patient is a recipient of a heart transplant;
  • Any elective surgical procedure is planned within 12 months of the index procedure;
  • Known illness or any serious clinical condition with life expectancy <2 years;
  • Participation in the active or follow-up phase of any other clinicaltrial within 6 months;
  • Impossibility to comply with anti-platelet therapy during the study clinical follow-up;
  • Any impossibility to comply with all protocol follow-ups.
  • Target lesion or vessel with angiographic evidence of moderate or severe calcification;
  • Presence of severe tortuosity;
  • Presence of severe angulation (>60o);
  • Presence of intraluminal thrombus;
  • Target lesion involving a bifurcation (side branch ≥2.0mm);
  • Target lesion located in the left main stem;
  • Aorto-ostial lesion location;
  • Target lesion involving a side branch with reference diameter≥2.0mm;
  • Presence of a significant stenosis (>40%) in the target vessel either proximal or distal to the target lesion that will be untreated;
  • Previous placement of a stent within 10mm of the target lesion;
  • Total occlusion (TIMI flow grade 0 or 1);
  • Target lesion located in an arterial or vein graft;
  • Target lesion due to in-stent restenosis;
  • Coronary anatomy unsuitable for percutaneous treatment with implantation of the available study stents.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Brazil1 site

  • Istituto Dante Pazzanesw

    São Paulo

Other trials in Brazil

Italy1 site

  • Azienda Ospedaliera Universitaria di Ferrara

    Ferrara

Other trials in Italy

About this study

Official title: The Best Trial - Brazilian and Italian Evaluation of Safety Using Tacrolimus-eluting Stent With Short-term Dual Antiplatelet Regimen

To evaluate the safety and efficacy of the Janus OPTIMA Tacrolimus-Eluting Stent (Optima TES, CID) for the treatment of de novo coronary lesions when associated with short-term (two months) dual antiplatelet (aspirin + clopidogrel) regimen.

Read the detailed description

The present study is a post-market, prospective, international, two-center, single arm study involving 60 patients with single, de novo non-complex coronary lesions.

Enrolled patients will be asked to return for follow-up clinical evaluation at 1, 6, 12 and 24 months. At 3 months there will be an additional follow-up by phone contact.

Furthermore, the first 15 patients should undergo angiographic and OCT follow-up at two months. The remaining 45 patients should undergo angiographic and IVUS follow-up at 8 months.

Being tested
Drug Eluting Stent
Keywords
Optima, Tacrolimus, Drug eluting stent

What participants receive

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

  • Drug Eluting StentDevice

What is being measured

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

  1. In-stent late lumen loss

    Measured: 8-month

Secondary outcomes (10)

  1. All-cause and cardiac mortality;

    Measured: up to 24 months

  2. Myocardial infarction (MI): Q-wave and non-Q-wave, cumulative and individual

    Measured: up to 24 months

  3. Major Adverse Cardiac Event (MACE) defined as a composite of cardiac death, MI (Q wave or non-Q wave), emergent coronary artery bypass surgery (CABG), or target lesion revascularization (TLR) by repeat PTCA or CABG

    Measured: up to 24 months

  4. Rate of stent thrombosis using ARC definition of definite and probable stent thrombosis and categorized as early, late or very late

    Measured: up to 24 months

  5. Stent strut coverage assessed by OCT

    Measured: 2 months

  6. Late acquired incomplete stent apposition by IVUS

    Measured: 8-month

  7. In stent & In segment angiographic parameters

    Measured: 8-month

  8. Clinically Driven TLR

    Measured: up to 24 months

  9. Clinically Driven TVR

    Measured: up to 24 months

  10. Target Lesion Failure (TLF) defined as cardiac death, MI and ischemic Target Lesion Revascularization (TLR)

    Measured: up to 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 posted13 May 2010 (estimated)
  2. Study startOct 2010
  3. Primary completionNov 2011
  4. Study completionMar 2013

Why it stopped: slow inclusion, due to difficulties in obtaining the patients consent for the 2 months invasive follow-up, as required by protocol design.

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
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01122719
Sponsor's protocol ID
C21002
Acronym
BEST
Status last verified
May 2018
First submitted
11 May 2010
Last updated
7 May 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Drug Eluting Stent in people with Stable Coronary Disease and Unstable Coronary Disease, run by CID - Carbostent & Implantable Devices at 2 sites in 2 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 37 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: stopped early, as of the sponsor's last update on 7 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Brazil, Italy. 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 was stopped early (reason given: slow inclusion, due to difficulties in obtaining the patients consent for the 2 months invasive follow-up, as required by protocol design.). Results are not available in the source record.

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?

In-stent late lumen loss (time frame: 8-month). 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 NCT01122719.

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 7 May 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in