Focal In-stent Restenosis After Drug-Eluting Stent — FOCUS  

In Stent Restenosis Clinical Trial

Official title: FOcal Type In-stent Restenosis After Drug-Eluting Stent Implantation Treated by CUtting Balloon Angioplasty Versus Sirolimus-Eluting Stent

Status Completed

Clinical Trial Summary

To evaluate the optimal management of focal in-stent restenosis after drug-eluting stent implantation with sirolimus-eluting implantation versus cutting balloon angioplasty

Clinical Trial Description

Following angiography, patients with focal DES restenosis (lesion length ≤ 10mm) with diameter stenosis >50% by visual estimation have documented myocardial ischemia or symptoms of angina, and eligible for PCI without any exclusion criteria will be randomized 1:1 to: a) Cypher stent vs. b) Cutting balloon angioplasty. All patients will be followed for 1 year. Angiographic follow-up at 9-months is mandatory. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• In Stent Restenosis

• NCT number: NCT00485004
• Study type: Interventional
• Source: CardioVascular Research Foundation, Korea
• Status: Completed
• Phase: Phase 4
• Start date: March 2007
• Completion date: March 2011