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

CID Carbostent & Implantable Devices

Status

Terminated

Conditions

Unstable Coronary Disease

Stable Coronary Disease

Documented Silent Ischemia

Treatments

Device: Drug Eluting Stent

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT01122719

C21002

Details and patient eligibility

About

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.

Full 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.

Enrollment

16 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.