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

Stable Coronary Disease Clinical Trial

— BEST  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01122719
• Other study ID #: C21002
• Status: Terminated
• Phase: N/A
• Start date: October 2010
• Est. completion date: March 2013

Study information

• Verified date: May 2018
• Source: CID - Carbostent & Implantable Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: March 2013
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Documented Silent Ischemia
• Ischemia
• Stable Coronary Disease
• Unstable Coronary Disease

Intervention

Device:
• Drug Eluting Stent

Locations

Country	Name	City	State
Brazil	Istituto Dante Pazzanesw	Sao Paulo
Italy	Azienda Ospedaliera Universitaria di Ferrara	Ferrara

Sponsors (2)

Lead Sponsor	Collaborator
CID - Carbostent & Implantable Devices	Contract research Organization: Cardiovascular Research Center - Sao Paulo, Brazil

Countries where clinical trial is conducted

Brazil,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-stent late lumen loss		8-month
Secondary	All-cause and cardiac mortality;		up to 24 months
Secondary	Myocardial infarction (MI): Q-wave and non-Q-wave, cumulative and individual		up to 24 months
Secondary	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
Secondary	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
Secondary	Stent strut coverage assessed by OCT		2 months
Secondary	Late acquired incomplete stent apposition by IVUS		8-month
Secondary	In stent & In segment angiographic parameters		8-month
Secondary	Clinically Driven TLR		up to 24 months
Secondary	Clinically Driven TVR		up to 24 months
Secondary	Target Lesion Failure (TLF) defined as cardiac death, MI and ischemic Target Lesion Revascularization (TLR)		up to 24 months