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

This study has been terminated.
(slow inclusion, due to difficulties in obtaining the patients consent for the 2 months invasive follow-up, as required by protocol design.)
Sponsor:
Collaborator:
Contract research Organization: Cardiovascular Research Center - Sao Paulo, Brazil
Information provided by:
CID - Carbostent & Implantable Devices
ClinicalTrials.gov Identifier:
NCT01122719
First received: May 11, 2010
Last updated: June 13, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Stable Coronary Disease
Unstable Coronary Disease
Documented Silent Ischemia
Device: Drug Eluting Stent
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Best Trial - Brazilian and Italian Evaluation of Safety Using Tacrolimus-eluting Stent With Short-term Dual Antiplatelet Regimen

Resource links provided by NLM:


Further study details as provided by CID - Carbostent & Implantable Devices:

Primary Outcome Measures:
  • In-stent late lumen loss [ Time Frame: 8-month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All-cause and cardiac mortality; [ Time Frame: up to 24 months ] [ Designated as safety issue: Yes ]
  • Myocardial infarction (MI): Q-wave and non-Q-wave, cumulative and individual [ Time Frame: up to 24 months ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: up to 24 months ] [ Designated as safety issue: Yes ]
  • Rate of stent thrombosis using ARC definition of definite and probable stent thrombosis and categorized as early, late or very late [ Time Frame: up to 24 months ] [ Designated as safety issue: Yes ]
  • Stent strut coverage assessed by OCT [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
  • Late acquired incomplete stent apposition by IVUS [ Time Frame: 8-month ] [ Designated as safety issue: Yes ]
  • In stent & In segment angiographic parameters [ Time Frame: 8-month ] [ Designated as safety issue: No ]
  • Clinically Driven TLR [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
  • Clinically Driven TVR [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
  • Target Lesion Failure (TLF) defined as cardiac death, MI and ischemic Target Lesion Revascularization (TLR) [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: October 2010
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01122719

Locations
Brazil
Istituto Dante Pazzanesw
Sao Paulo, Brazil
Italy
Azienda Ospedaliera Universitaria di Ferrara
Ferrara, Italy
Sponsors and Collaborators
CID - Carbostent & Implantable Devices
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
  More Information

No publications provided

Responsible Party: Cristina Isaia - Clinical Affairs Director, CID srl
ClinicalTrials.gov Identifier: NCT01122719     History of Changes
Other Study ID Numbers: C21002
Study First Received: May 11, 2010
Last Updated: June 13, 2011
Health Authority: Italy: Ethics Committee
Brazil: National Committee of Ethics in Research

Keywords provided by CID - Carbostent & Implantable Devices:
Optima
Tacrolimus
Drug eluting stent

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Ischemia
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014