Clinical trial NCT01093391: A Trial of Bare Metal Stent - Cobalt Chromium Versus Stent Coating With Sirolimus
Official title: A Randomized Trial of Bare Metal Stent (Cronus®) - Cobalt Chromium Versus Stent Coating With Sirolimus (DES)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Disease
Keywords: coronary artery
thrombosis
stent
Lead sponsor: Scitech Produtos Medicos Ltda
Sponsor class: INDUSTRY
First posted: 2010-03-25
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the security issues and efficacy of coronary stenting Cobalt Chrome covered with sirolimus-eluting Cobalt Chrome platform in patients with coronary artery lesion.

Detailed description: Patients will be treated in compliance with the eligibility criteria, with stent study of 16-19mm. All patients are clinically followed for 60 months after the procedure and will undergo a control angiography 6 months. Can be treated multiple lesions, measuring between 2.5-3.5mm (by visual estimate). Patients enrolled will be randomized in a 1:2 propose in one of the groups with or without stent coating, respectively. And a randomized clinical trial, prospective study in 5 centers including 60 patients.

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 16- 19mm-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;

4.3. ANGIOGRAPHIC 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 16-19mm 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: Lumen Loss
timeFrame: 6 months after the procedure
Secondary outcomes:
measure: Adverse Cardiac Events
timeFrame: 30 days, 6, 12 and 60 months after the procedure
Other outcomes:
Locations:
city: Barbacena
country: Brazil
facility: Hospital Ibiapaba de Barbacena
state: MG
city: São Paulo
country: Brazil
facility: Instituto de Assistêcia Médica ao Servidor Publico Estadual
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 Santa Marcelina
state: SP
Study officials:
affiliation: Instituto do Coração do Hospital das Clínicas da Fac. de Medicina da USP
name: Expedito E. Ribeiro da Silva, Medicine
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carlos Augusto Homem de Magalhães Campos; Celso K. Takimura; Guilherme B. Gregores; Carlos A. Sarmento; Emerson T. Fioretto; Fracisco R. M. Laurindo; Expedito E. Ribeiro; Eulógio E. Martinez; Thiago F.C.C. Borges; Pedro A. Lemos. Redução neointimal com Stent com polímero biodegradável e Sirolimus desenvolvido no Brasil: Resultados preliminares em Suínos. Rev. Soc. Cardiol. Estado de São Paulo - Supl. B - Vol. 19
citation: Oliveira MD, Ribeiro EE, Campos CM, Ribeiro HB, Faillace BL, Lopes AC, Esper RB, Meirelles GX, Perin MA, Abizaid A, Lemos PA. Four-year clinical follow-up of the first-in-man randomized comparison of a novel sirolimus eluting stent with abluminal biodegradable polymer and ultra-thin strut cobalt-chromium alloy: the INSPIRON-I trial. Cardiovasc Diagn Ther. 2015 Aug;5(4):264-70. doi: 10.3978/j.issn.2223-3652.2015.07.05.
citation: Ribeiro EE, Campos CM, Ribeiro HB, Lopes AC, Esper RB, Meirelles GX, Perin MA, Abizaid A, Lemos PA. First-in-man randomised comparison of a novel sirolimus-eluting stent with abluminal biodegradable polymer and thin-strut cobalt-chromium alloy: INSPIRON-I trial. EuroIntervention. 2014;9(12):1380-4. doi: 10.4244/EIJV9I12A234.