A Trial of Bare Metal Stent - Cobalt Chromium Versus Stent Coating With Sirolimus

Phase 3

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: DRUG ELUTING STENT; Device: BARE METAL STENT

• Registration Number: NCT01093391
• Lead Sponsor: Scitech Produtos Medicos Ltda

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.

Study Timeline

• Study First Submitted: 2010-03-18
• Study First Submitted QC: 2010-03-24
• Study First Posted: 2010-03-25
• Study Start: 2010-11
• Status Verified: 2015-07
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Last Update Submitted: 2015-07-20
• Last Update Posted: 2015-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DRUG ELUTING STENT	DRUG ELUTING STENT	STENT INSPIRON WITH SIROLIMUS
BARE METAL STENT	BARE METAL STENT	BARE METAL STENT - STENT CRONUS

Primary Outcome Measures

Name	Time	Method
Lumen Loss	6 months after the procedure	For an accurate assessment of the stent conditions 6 months after implantation, a follow-up catheterization will be performed at the 6-month visit in order to measure the diameter of the artery at the stented site. The objective is the lumen loss in-segment (including the portion in-stent and edges of 5 mm proximal and distal) at 6 months.

Secondary Outcome Measures

Name	Time	Method
Adverse Cardiac Events	30 days, 6, 12 and 60 months after the procedure	The clinical follow-up should be performed during the index procedure at 30 days, 6, 12 and 60 months post-procedure, and should consist of an assessment of the angina status (according to the Canadian Cardiovascular Society Classification and the Braunwald Classification for unstable angina) and major adverse cardiac events and any interventional treatment (e.g.: repeated target lesion revascularization or recurrent ischemia).

Trial Locations

Locations (4)

Hospital Ibiapaba de Barbacena; 🇧🇷 Barbacena, MG, Brazil

Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP; 🇧🇷 São Paulo, SP, Brazil

Instituto de Assistêcia Médica ao Servidor Publico Estadual; 🇧🇷 São Paulo, SP, Brazil

Hospital Santa Marcelina; 🇧🇷 São Paulo, SP, Brazil