NCT01239953

RIBS V (Restenosis Intra-stent of Bare Metal Stents: Paclitaxel-eluting Balloon vs Everolimus-eluting Stent)

RIBS V (Restenosis Intra-stent of Bare Metal Stents: Paclitaxel-eluting Balloon vs Everolimus-eluting Stent). A Prospective, Multicenter and Randomized Clinical Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 190 (actual)
• Sponsor: Fundación Médica para la Investigación y Desarrollo en el Area Cardiovascular · Academic / Other
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Treatment of patients with bare metal stent restenosis remains a challenge. This study will assess which interventional strategy (paclitaxel-eluting balloon vs everolimus-eluting stent) is superior in the treatment of patients suffering from bare metal stent restenosis.

Detailed description

Treatment of patients with bare metal stent restenosis remains a major clinical and technical challenge. Currently, drug-eluting stents are widely used in the management of these patients. Recently, the value of the paclitaxel-eluting balloon in this clinical setting has been suggested. However, there is only scarce observational data on the value of this new balloon in patients with bare metal stent restenosis. This prospective, multicenter, randomized clinical trial will compare two different interventional strategies (namely, paclitaxel-eluting balloon vs everolimus-eluting stent) in the treatment of patients with bare metal stent restenosis.

Conditions

• In-Stent Restenosis

Interventions

Type	Name	Description
DEVICE	Coronary angioplasty using the paclitaxel-eluting balloon	Balloon angioplasty
DEVICE	Coronary angioplasty using the everolimus-eluting stent	Stent implantation

Timeline

• Start date: 2010-01-01
• Primary completion: 2012-07-01
• First posted: 2010-11-15
• Last updated: 2012-02-27

Locations

25 sites across 1 country: Spain