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

NCT ID: NCT01122719

Last Updated: 2018-05-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2013-03-31

Brief 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.

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.

Conditions

Stable Coronary Disease; Unstable Coronary Disease; Documented Silent Ischemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Drug Eluting Stent

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Contract research Organization: Cardiovascular Research Center - Sao Paulo, Brazil

UNKNOWN

Sponsor Role: collaborator

CID - Carbostent & Implantable Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marco Valgimigli, Dr

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliero Universitaria di Ferrara - Italy

Alexandre Abizaid, Dr

Role: PRINCIPAL_INVESTIGATOR

Instituto Dante Pazzanese de Cardiologia

Locations

Istituto Dante Pazzanesw

São Paulo, , Brazil

Azienda Ospedaliera Universitaria di Ferrara

Ferrara, , Italy

Countries

Brazil; Italy

Other Identifiers

C21002

Identifier Type: -

Identifier Source: org_study_id