NCT00322569

A Randomized, Multi-Center Study of the Pimecrolimus-Eluting and Pimecrolimus/Paclitaxel-Eluting Coronary Stent Systems (GENESIS)

A Randomized, Multi-Center Study of the Pimecrolimus-Eluting (Corio™) and Pimecrolimus/Paclitaxel-Eluting Coronary Stent System (SymBio™) in Patients With De Novo Lesions of the Native Coronary Arteries

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 246 (actual)
• Sponsor: Cordis US Corp. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To demonstrate non-inferiority in 6-month angiographic in-stent late lumen loss of the pimecrolimus-eluting coronary stent (Corio) compared to the CoStar coronary stent control arm and the dual pimecrolimus/paclitaxel-eluting (Symbio) coronary stent compared to the CoStar coronary stent control arm for the treatment of single de novo lesions \<25 mm in length in native coronary arteries 2.5 - 3.5 mm in diameter.

Detailed description

This study is designed to evaluate 6 month in-stent late lumen loss of the 1) Corio™ pimecrolimus-eluting coronary stent system and the 2) SymBio™ dual pimecrolimus/paclitaxel-eluting coronary stent system compared to the CoStar™ Paclitaxel-Eluting Coronary Stent System control arm.

Conditions

• Coronary Disease

Interventions

Type	Name	Description
DEVICE	Corio™ Pimecrolimus-Eluting Coronary Stent System	Drug-eluting stent
DEVICE	SymBio™ Pimecrolimus/Paclitaxel-Eluting Coronary Stent System	Drug-eluting stent
DEVICE	Costar ™ Paclitaxel-Eluting Coronary Stent System	Drug-eluting Stent

Timeline

• Start date: 2006-07-01
• Primary completion: 2007-10-01
• Completion: 2012-05-01
• First posted: 2006-05-08
• Last updated: 2013-03-06

Locations

1 site across 1 country: United Kingdom