NCT01239940

RIBS IV (Restenosis Intra-stent of Drug-eluting Stents: Paclitaxel-eluting Balloon vs Everolimus-eluting Stent)

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 310 (estimated)
• 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 drug-eluting 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 drug-eluting stent restenosis.

Detailed description

Treatment of patients with drug-eluting 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 drug-eluting 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 drug-eluting 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: 2011-06-27

Locations

25 sites across 1 country: Spain