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

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centro de estudios en Cardiologia Intervencionista
• Treatments: Everolimus; Paclitaxel; Sirolimus

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