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

NCT01093391 | Completed Phase 3 DMC

• 1 other identifier: Scitech 001
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 4

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.

Conditions

Coronary Artery Disease

Keywords

coronary artery; thrombosis; stent

Outcome Measures

Primary Outcomes (1)

• Lumen Loss

  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.

  6 months after the procedure

Secondary Outcomes (1)

• Adverse Cardiac Events

  30 days, 6, 12 and 60 months after the procedure

Study Arms (2)

BARE METAL STENT

PLACEBO COMPARATOR

BARE METAL STENT - STENT CRONUS

Device: BARE METAL STENT

DRUG ELUTING STENT

EXPERIMENTAL

STENT INSPIRON WITH SIROLIMUS

Device: DRUG ELUTING STENT

Interventions

DRUG ELUTING STENT DEVICE

Site preparation and percutaneous access should be performed as per standard hospital procedures.It is recommended to cross the target lesion with 0.014-inch exchange-length guide wire. The involved lesion should be predilated with appropriately sized balloons using standard techniques. It is strongly encouraged that the Investigators use similar materials and techniques throughout the study to maintain consistency and standardization of care.A stent consists of an endovascular prosthesis with a metallic mesh structure that is implanted at the site of the artery blockage via catheterization procedure. The objective of stenting is to obtain an angiographic appearance of the expanded stent only outside the limits of the target vessel filled with contrast medium.

Also known as: Angiography, Stenting

DRUG ELUTING STENT

BARE METAL STENT DEVICE

Site preparation and percutaneous access should be performed as per standard hospital procedures.It is recommended to cross the target lesion with 0.014-inch exchange-length guide wire. The involved lesion should be predilated with appropriately sized balloons using standard techniques. It is strongly encouraged that the Investigators use similar materials and techniques throughout the study to maintain consistency and standardization of care.A stent consists of an endovascular prosthesis with a metallic mesh structure that is implanted at the site of the artery blockage via catheterization procedure. The objective of stenting is to obtain an angiographic appearance of the expanded stent only outside the limits of the target vessel filled with contrast medium.

BARE METAL STENT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• 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 16- 19mm-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 (4)

Hospital Ibiapaba de Barbacena

Barbacena, Minas Gerais, 36201-356, Brazil

Location

Instituto de Assistêcia Médica ao Servidor Publico Estadual

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 Santa Marcelina

São Paulo, São Paulo, 08270-070, Brazil

Location

Related Publications (3)

• 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

  RESULT

• 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.

  PMID: 26331110 DERIVED

• 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.

  PMID: 24755382 DERIVED

Related Links

• Sponsor site
• Site about the location that will be done the study. Location where the principal investigator works.
• National Information System on Ethics in Research involving Human

MeSH Terms

Conditions

Coronary Artery Disease; Thrombosis

Interventions

Drug-Eluting Stents; Angiography; Stents

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Cardiovascular

Study Officials

• Expedito E. Ribeiro da Silva, Medicine

  Instituto do Coração do Hospital das Clínicas da Fac. de Medicina da USP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• 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 25, 2010
• Study Start: November 1, 2010
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: July 22, 2015

Record last verified: 2015-07

Locations

BR (4)