Clinical trial NCT01090609: Study to Evaluate the Safety of Cronus® - Cobalt Chromium Coronary Stent
Official title: Multicenter, Prospective, Non-randomized Study to Evaluate the Safety of Cronus® Cobalt Chromium Coronary Stent - Study After 9 Months
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: Coronary Stent
Cobalt-Chromium coronary stent
Lead sponsor: Scitech Produtos Medicos Ltda
Sponsor class: INDUSTRY
First posted: 2010-03-22
Enrollment: 263
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: The use of coronary stents has optimized the results of coronary balloon angioplasty for two reasons:

1. reduced acute complications, such as acute and subacute occlusion, as well as the need of urgent myocardial revascularization;
2. 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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years and ≤75 years;
2. Symptomatic cardiac ischemic disease and/or documented evidence of myocardial ischemia;
3. Types B1 and B2 coronary lesions (according to the ACC/AHA classification modified by Ellis);
4. Target lesion located in a native coronary artery;
5. 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;
6. Target lesion with \>50% diameter stenosis (by visual estimate);
7. Acceptable candidate to myocardial revascularization surgery (coronary artery bypass graft surgery);
8. 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:

1. Female patients of childbearing potential;
2. 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;
3. Documented left ventricular ejection fraction \<30%;
4. Renal dysfunction (creatinine \> 2.0 mg/dL or 177 µmol/L);
5. Platelet count \<100,000 cells/mm³ or \>700,000 cells/mm³.;
6. White blood cell count \<3,000 cells/mm3;
7. Suspected or documented hepatic disease (including laboratorial evidence of hepatitis);
8. Heart transplant receptor;
9. Known hypersensitivity to cobalt-chromium or to medications such as aspirin, clopidogrel bisulfate (Plavix or ISCOVER), ticlopidine (Ticlid) or heparin.
10. Concurrent medical condition with a life expectancy of less than 12 months;
11. Any major medical condition that, in the Investigator's opinion, may interfere with the optimal participation of the patient in this study;
12. 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;
13. Coronary angioplasty (with or without stenting) less than 9 months before the index procedure at any site of the target vessel;
14. 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.
15. 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:

1. Restenotic target lesion;
2. More than one lesion requiring treatment in the same vessel;
3. Target vessel diameter \<2.5 mm or \>3.5 mm (by visual estimation);
4. Long target lesion not amenable to treatment (coverage) with a 19-mm-long stent;
5. Unprotected coronary artery branch lesion (≥50% diameter stenosis)
6. Target lesion is located in a surgical bypass graft;
7. Total vessel occlusion (TIMI flow grade 0-1);
8. Target lesion with ostial location;
9. Target lesion located in a lateral branch bifurcation \>2.5mm or requiring lateral branch stenting;
10. Calcified target lesion that anticipates unsuccessful/impracticable predilation;
11. Target vessel with excessive tortuosity

Primary outcomes:
measure: Clinical Follow-up
timeFrame: 30 days after the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Goiânia
country: Brazil
facility: Hospital São Salvador Goiânia
state: GO
city: Goiânia
country: Brazil
facility: Hospital Santa Genoveva
state: GO
city: Belo Horizonte
country: Brazil
facility: Irmandade Santa Casa de Misericórdia de Belo Horizonte
state: MG
city: Blumenau
country: Brazil
facility: Hospital Santa Isabel
state: SC
city: São Paulo
country: Brazil
facility: Instituto Dante Pazzanese de Cardiologia
state: SP
city: São Paulo
country: Brazil
facility: Instituto de Assistência Médica ao Servidor Público Estadual - Iamspe
state: SP
city: São Paulo
country: Brazil
facility: Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP
state: SP
city: São Paulo
country: Brazil
facility: Hospital São Paulo - UNIFESP
state: SP
city: Colatina - ES
country: Brazil
facility: São Bernardo Apart Hospital
city: Franca - SP
country: Brazil
facility: Santa Casa de Franca
city: Patos de Minas - MG
country: Brazil
facility: Hospital Vera Cruz
city: Recife - PE
country: Brazil
facility: Instituto de Medicina Integral Professor Fernando Figueira - IMIP
city: São José do Rio Preto - SP
country: Brazil
facility: Santa Casa de Misericórdia de São José do Rio Preto
Study officials:
affiliation: Instituto Dante Pazzanese de Cardiologia
name: Fausto Feres, Medicine
role: PRINCIPAL_INVESTIGATOR
References: