- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01090609
Study to Evaluate the Safety of Cronus® - Cobalt Chromium Coronary Stent (CRONUS)
Multicenter, Prospective, Non-randomized Study to Evaluate the Safety of Cronus® Cobalt Chromium Coronary Stent - Study After 9 Months
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The use of coronary stents has optimized the results of coronary balloon angioplasty for two reasons:
- reduced acute complications, such as acute and subacute occlusion, as well as the need of urgent myocardial revascularization;
- reduced coronary restenosis. STRESS and BENESTENT 1 pivotal clinical trials7,9 laid the foundations for approval and confirmation of the efficacy of coronary stents. These studies showed a reduction in the binary angiographic restenosis rates from 42.1% to 31.6% (p<0.05) and from 32% to 22% (p=0.02), respectively. The efficacy of coronary stents is due to the fact that these devices reduce the acute elastic recoil and late negative remodeling of coronary arteries because of their capacity to maintain the vessel adequately open without reducing vessel diameter.
Cronus® stent is fabricated in cobalt-chromium. This alloy is currently used cardiovascular stents and permanent implants in orthopedic (hips, knees), dental and maxillofacial surgeries. Guidant and Medtronic have conducted clinical evaluations of stents fabricated with a similar cobalt-chromium alloy and demonstrated safety and efficacy of the investigational devices. Both stents are currently available in the European market.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Colatina - ES, Brazil, 29700-790
- São Bernardo Apart Hospital
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Franca - SP, Brazil, 14400-730
- Santa Casa de Franca
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Patos de Minas - MG, Brazil, 38700-160
- Hospital Vera Cruz
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Recife - PE, Brazil, 50070-050
- Instituto de Medicina Integral Professor Fernando Figueira - IMIP
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São José do Rio Preto - SP, Brazil
- Santa Casa de Misericórdia de São José do Rio Preto
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GO
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Goiânia, GO, Brazil, 74110-020
- Hospital São Salvador Goiânia
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Goiânia, GO, Brazil, 74670-430
- Hospital Santa Genoveva
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MG
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Belo Horizonte, MG, Brazil
- Irmandade Santa Casa de Misericórdia de Belo Horizonte
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SC
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Blumenau, SC, Brazil, 89010-906
- Hospital Santa Isabel
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SP
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São Paulo, SP, Brazil, 05403-000
- Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP
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São Paulo, SP, Brazil, 04012-909
- Instituto Dante Pazzanese de Cardiologia
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São Paulo, SP, Brazil, 04029-000
- Instituto de Assistencia Medica ao Servidor Publico Estadual - IAMSPE
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São Paulo, SP, Brazil
- Hospital Sao Paulo - UNIFESP
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
Angiography Exclusion Criteria:
- Restenotic target lesion;
- More than one lesion requiring treatment in the same vessel;
- Target vessel diameter <2.5 mm or >3.5 mm (by visual estimation);
- Long target lesion not amenable to treatment (coverage) with a 19-mm-long stent;
- Unprotected coronary artery branch lesion (≥50% diameter stenosis)
- Target lesion is located in a surgical bypass graft;
- Total vessel occlusion (TIMI flow grade 0-1);
- Target lesion with ostial location;
- Target lesion located in a lateral branch bifurcation >2.5mm or requiring lateral branch stenting;
- Calcified target lesion that anticipates unsuccessful/impracticable predilation;
- Target vessel with excessive tortuosity
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Stent implantation
Cronus Stent implantation
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Stent implantation
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Follow-up
Time Frame: 30 days after the procedure
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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.
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30 days after the procedure
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Fausto Feres, Medicine, Instituto Dante Pazzanese de Cardiologia
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Scitech 002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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