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Study of Oral Rapamycin Plus Bare Metal Stents vs Drug Eltuting Stents

Information source: Centro de estudios en Cardiologia Intervencionista
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Coronary Heart Disease; Coronary Restenosis

Intervention: Oral sirolimus (Drug); Drug Eluting stent (Device)

Phase: Phase 4

Status: Completed

Sponsored by: Centro de estudios en Cardiologia Intervencionista

Official(s) and/or principal investigator(s):
Alfredo E Rodriguez, MD PhD FACC, Study Chair, Affiliation: Departamento de Cardiologia Intervencionista, Sanatorio Otamendi
Carlos Fernandez Pereira, MD, Study Director, Affiliation: Departamento de Cardiologia Intervencionista, Sanatorio Otamendi

Summary

In a previous randomized comparison oral sirolimus plus bare metal stent compared to bare metal stent implantation alone demonstrated at one year of follow up a significant reduction of angiographic and clinical parameters of restenosis (ANMAT resolution number 3366 from June 2004 and Rodriguez A et al JACC,2006,47,1522-1529). In addition previous reported registries from our group with Drug Eluting Stents showed similar amount of reduction in clinical parameters (not angiographic)of restenosis (ERACI III, Rodriguez A et al EuroIntervention 2006,2: 53-60). Taking in account that 8. 3% of patients treated with oral rapamycin plus Bare Metal Stents(ORAR II Trial JACC 2006)and 8. 8% of patients treated with DES developed clinical restenosis (ERACI III Registry, EuroIntervention 2006) the investigators sought to compare differences in overall cost with both revascularization strategies at 1, 2, 3 and 5 years of follow up assuming that safety and efficacy clinical end points would be similar.

Clinical Details

Official title: Phase 4 Study of Randomized Comparison Among Oral Rapamycin Plus Bare Metal Stents Versus Drug Eluting Stents in de Novo Coronary Lesions.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Primary outcome: Differences in Costs Between Two Revascularization Strategies for de Novo Coronary Lesions.

Secondary outcome:

Major Adverse Cardiovascular Events (MACCE)

Target Vessel Revascularization (TVR)

Detailed description: Patients with de novo lesions treated in different Institutions in Buenos Aires Argentina were randomized to treat with oral sirolimus plus bare metal stent implantation (100 patients) or DES(100 patients).

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Indication of revascularization

- De novo lesions

- Native vessels

- Suitable for stent placement

Exclusion Criteria:

- Acute myocardial infarction within the last 24 hours

- In stent restenosis

- Previous percutaneous coronary intervention within the last 6 months

Locations and Contacts

Sanatorio Otamendi y Miroli, Buenos Aires 1115, Argentina

Clinica IMA, Adrogue, Buenos Aires 1846, Argentina

Sanatorio Las Lomas, San Isidro, Buenos Aires 1354, Argentina

Additional Information

Circulation

Pubmed abstract of the latest published results.

Related publications:

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Starting date: January 2006
Last updated: May 27, 2010

Page last updated: August 23, 2015

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