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

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.

Study Overview

• Status: Terminated
• Conditions: Stable Coronary Disease; Unstable Coronary Disease; Documented Silent Ischemia
• Intervention / Treatment: Device: Drug Eluting Stent

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil
    • Istituto Dante Pazzanesw
• Italy
  • Ferrara, Italy
    • Azienda Ospedaliera Universitaria di Ferrara

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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
• 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.

Exclusion Criteria:

• 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;
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
In-stent late lumen loss	8-month

Secondary Outcome Measures

Outcome Measure	Time Frame
All-cause and cardiac mortality;	up to 24 months
Myocardial infarction (MI): Q-wave and non-Q-wave, cumulative and individual	up to 24 months
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	up to 24 months
Rate of stent thrombosis using ARC definition of definite and probable stent thrombosis and categorized as early, late or very late	up to 24 months
Stent strut coverage assessed by OCT	2 months
Late acquired incomplete stent apposition by IVUS	8-month
In stent & In segment angiographic parameters	8-month
Clinically Driven TLR	up to 24 months
Clinically Driven TVR	up to 24 months
Target Lesion Failure (TLF) defined as cardiac death, MI and ischemic Target Lesion Revascularization (TLR)	up to 24 months

Collaborators and Investigators

• Sponsor: CID - Carbostent & Implantable Devices
• Collaborators: Contract research Organization: Cardiovascular Research Center - Sao Paulo, Brazil
• Investigators: Principal Investigator: Marco Valgimigli, Dr, Azienda Ospedaliero Universitaria di Ferrara - Italy; Principal Investigator: Alexandre Abizaid, Dr, Instituto Dante Pazzanese de Cardiologia

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2010
• Primary Completion (ACTUAL): November 1, 2011
• Study Completion (ACTUAL): March 1, 2013

Study Registration Dates

• First Submitted: May 11, 2010
• First Submitted That Met QC Criteria: May 11, 2010
• First Posted (ESTIMATE): May 13, 2010

Study Record Updates

• Last Update Posted (ACTUAL): May 7, 2018
• Last Update Submitted That Met QC Criteria: May 2, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Drug eluting stent; Tacrolimus; Optima
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Coronary Disease; Ischemia
• Other Study ID Numbers: C21002