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

NCT01122719 | Terminated DMC

• 1 other identifier: C21002
• Study Type: interventional
• Target: 16
• Locations: 2 countries
• Sites: 2

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.

Conditions

Stable Coronary Disease; Unstable Coronary Disease; Documented Silent Ischemia

Keywords

Optima; Tacrolimus; Drug eluting stent

Outcome Measures

Primary Outcomes (1)

• In-stent late lumen loss

  8-month

Secondary Outcomes (10)

• 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

Interventions

Drug Eluting Stent DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• CID - Carbostent & Implantable Devices: lead
• Contract research Organization: Cardiovascular Research Center - Sao Paulo, Brazil: collaborator

Study Sites (2)

Istituto Dante Pazzanesw

São Paulo, Brazil

Location

Azienda Ospedaliera Universitaria di Ferrara

Ferrara, Italy

Location

MeSH Terms

Interventions

Drug-Eluting Stents

Intervention Hierarchy (Ancestors)

Stents; Prostheses and Implants; Equipment and Supplies

Study Officials

• Marco Valgimigli, Dr

  Azienda Ospedaliero Universitaria di Ferrara - Italy

  PRINCIPAL INVESTIGATOR

• Alexandre Abizaid, Dr

  Instituto Dante Pazzanese de Cardiologia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2010
• First Posted: May 13, 2010
• Study Start: October 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: March 1, 2013
• Last Updated: May 7, 2018

Record last verified: 2018-05

Locations

IT (1); BR (1)