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

A Randomized Trial of Bare Metal Stent (Cronus®) - Cobalt Chromium Versus Stent Coating With Sirolimus (DES)

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: BARE METAL STENT; Device: DRUG ELUTING STENT

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 Type: Interventional
• Enrollment (Actual): 63
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • MG
    • Barbacena, MG, Brazil, 36201-356
      • Hospital Ibiapaba de Barbacena
  • SP
    • São Paulo, SP, Brazil, 04029-000
      • Instituto de Assistêcia Médica ao Servidor Publico Estadual
    • São Paulo, SP, Brazil, 05403-000
      • Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP
    • São Paulo, SP, Brazil, 08270-070
      • Hospital Santa Marcelina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: BARE METAL STENT; BARE METAL STENT - STENT CRONUS	Device: BARE METAL STENT; 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.
Experimental: DRUG ELUTING STENT; STENT INSPIRON WITH SIROLIMUS	Device: DRUG ELUTING STENT; 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.; Other Names: Angiography, Stenting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Cardiac Events	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).	30 days, 6, 12 and 60 months after the procedure

Collaborators and Investigators

• Sponsor: Scitech Produtos Medicos Ltda
• Investigators: Principal Investigator: Expedito E. Ribeiro da Silva, Medicine, Instituto do Coração do Hospital das Clínicas da Fac. de Medicina da USP

Publications and helpful links

General Publications

• 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
• 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.
• 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.

Helpful 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

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: March 18, 2010
• First Submitted That Met QC Criteria: March 24, 2010
• First Posted (Estimate): March 25, 2010

Study Record Updates

• Last Update Posted (Estimate): July 22, 2015
• Last Update Submitted That Met QC Criteria: July 20, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: stent; thrombosis; coronary artery
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: Scitech 001