Study to Evaluate the Safety of Cronus® - Cobalt Chromium Coronary Stent

NCT01090609 | Completed Phase 4 DMC

• 1 other identifier: Scitech 002
• Study Type: interventional
• Target: 263
• Locations: 1 country
• Sites: 13

Brief Summary

The objective this study is evaluate the performance and safety of Chronus® cobalt-chromium coronary stent in patients with "de novo" native coronary artery lesions treated with 19-mm-long stents in long-term 9 months.

Conditions

Coronary Artery Disease

Keywords

Coronary Stent; Cobalt-Chromium coronary stent

Outcome Measures

Primary Outcomes (1)

• Clinical Follow-up

  All patients are invited to return for a clinical visit at 30 days post-procedure to evaluate possible adverse events and on the continuity of cardiac medication.

  30 days after the procedure

Study Arms (1)

Stent implantation

EXPERIMENTAL

Cronus Stent implantation

Device: Stent implantation

Interventions

Stent implantation DEVICE

Stent implantation

Also known as: Angioplasty

Stent implantation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years and ≤75 years;
• Symptomatic cardiac ischemic disease and/or documented evidence of myocardial ischemia;
• Types B1 and B2 coronary lesions (according to the ACC/AHA classification modified by Ellis);
• Target lesion located in a native coronary artery;
• Target lesion in vessel with diameter ranging from 2.5 to 3.5 mm (by visual estimate) amenable to treatment (coverage) with a 19-mm-long stent;
• Target lesion with \>50% diameter stenosis (by visual estimate);
• Acceptable candidate to myocardial revascularization surgery (coronary artery bypass graft surgery);
• The subject has been fully informed of the nature of the study, is willing to comply with all study requirements and will provide written informed consent as approved by the Ethics Committee of the respective clinical site.

You may not qualify if:

• Female patients of childbearing potential;
• Recent Q-wave myocardial infarction occurred within 48 hours prior to the index procedure. Recent Q-wave or non-Q-wave myocardial infarction with still elevated levels of cardiac markers;
• Documented left ventricular ejection fraction \<30%;
• Renal dysfunction (creatinine \> 2.0 mg/dL or 177 µmol/L);
• Platelet count \<100,000 cells/mm³ or \>700,000 cells/mm³.;
• White blood cell count \<3,000 cells/mm3;
• Suspected or documented hepatic disease (including laboratorial evidence of hepatitis);
• Heart transplant receptor;
• Known hypersensitivity to cobalt-chromium or to medications such as aspirin, clopidogrel bisulfate (Plavix or ISCOVER), ticlopidine (Ticlid) or heparin.
• Concurrent medical condition with a life expectancy of less than 12 months;
• Any major medical condition that, in the Investigator's opinion, may interfere with the optimal participation of the patient in this study;
• Subject is currently participating in an investigational drug or another device study, including planned participation in an investigational drug or another device study during the course of the present investigation;
• Coronary angioplasty (with or without stenting) less than 9 months before the index procedure at any site of the target vessel;
• Previous coronary angioplasty (with or without stenting) at any time (\>9 months) in a vessel segment less than 5 mm proximal or distal to the target lesion.
• Planned coronary angioplasty (with or without stenting) in the first 12 months after the index procedure in any segment of the target vessel;

Sponsors & Collaborators

• Scitech Produtos Medicos Ltda: lead

Study Sites (13)

Hospital São Salvador Goiânia

Goiânia, Goiás, 74110-020, Brazil

Location

Hospital Santa Genoveva

Goiânia, Goiás, 74670-430, Brazil

Location

Irmandade Santa Casa de Misericórdia de Belo Horizonte

Belo Horizonte, Minas Gerais, Brazil

Location

Hospital Santa Isabel

Blumenau, Santa Catarina, 89010-906, Brazil

Location

Instituto Dante Pazzanese de Cardiologia

São Paulo, São Paulo, 04012-909, Brazil

Location

Instituto de Assistência Médica ao Servidor Público Estadual - Iamspe

São Paulo, São Paulo, 04029-000, Brazil

Location

Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP

São Paulo, São Paulo, 05403-000, Brazil

Location

Hospital São Paulo - UNIFESP

São Paulo, São Paulo, Brazil

Location

São Bernardo Apart Hospital

Colatina - ES, 29700-790, Brazil

Location

Santa Casa de Franca

Franca - SP, 14400-730, Brazil

Location

Hospital Vera Cruz

Patos de Minas - MG, 38700-160, Brazil

Location

Instituto de Medicina Integral Professor Fernando Figueira - IMIP

Recife - PE, 50070-050, Brazil

Location

Santa Casa de Misericórdia de São José do Rio Preto

São José Do Rio Preto - SP, Brazil

Location

Related Links

• Sponsor site
• National Information System on Ethics in Research involving Human

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Angioplasty

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Fausto Feres, Medicine

  Instituto Dante Pazzanese de Cardiologia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2010
• First Posted: March 22, 2010
• Study Start: May 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: November 1, 2014
• Last Updated: November 14, 2014

Record last verified: 2014-11

Locations

BR (13)