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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Scitech Produtos Medicos Ltda
ClinicalTrials.gov Identifier:
NCT01093391
First received: March 18, 2010
Last updated: July 2, 2012
Last verified: July 2010
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Device: Cobalt- Chromium Coronary Stent coating with Sirolimus - Inspiron® (Angioplasty)
Device: Cronus®
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Trial of Bare Metal Stent (Cronus®) - Cobalt Chromium Versus Stent Coating With Sirolimus (DES)

Resource links provided by NLM:


Further study details as provided by Scitech Produtos Medicos Ltda:

Primary Outcome Measures:
  • Lumen Loss [ Time Frame: 6 months after the procedure ] [ Designated as safety issue: Yes ]
    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:
  • Adverse Cardiac Events [ Time Frame: 30 days, 6, 12 and 60 months after the procedure ] [ Designated as safety issue: Yes ]
    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).


Estimated Enrollment: 57
Study Start Date: November 2010
Estimated Study Completion Date: December 2015
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: BARE METAL STENT
BARE METAL STENT STENT CRONUS
Device: Cronus®
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: Cobalt- Chromium Coronary Stent coating with Sirolimus - Inspiron® (Angioplasty)
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 Name: Angiography, Stenting

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01093391

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

Additional Information:
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

Responsible Party: Scitech Produtos Medicos Ltda
ClinicalTrials.gov Identifier: NCT01093391     History of Changes
Other Study ID Numbers: Scitech 001
Study First Received: March 18, 2010
Last Updated: July 2, 2012
Health Authority: United States: Food and Drug Administration
Brazil: Ministry of Health

Keywords provided by Scitech Produtos Medicos Ltda:
coronary artery
thrombosis
stent

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Everolimus
Chromium
Cobalt
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Trace Elements
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on September 16, 2014