Drug-eluting Balloon vs. Conventional Balloon in the Treatment of (re)Stenosis - a Randomized Prospective Study — DRECOREST1  

Peripheral Artery Occlusive Disease Clinical Trial

Official title: Drug-eluting Balloon vs. Conventional Balloon in the Treatment of (re)Stenosis - a Randomized Prospective Study

Status Completed

Clinical Trial Summary

The purpose of this study is to determine whether the use of drug-eluting balloons is effective in the treatment of (re)stenosis in bypass vein grafts.

Clinical Trial Description

Drug-eluting devices have proved beneficial in the treatment of stenosis in native coronary and lower limb arteries. Stenosis and restenosis is a known problem in bypass vein grafts, and drug-eluting devices might be beneficial in this field as well.

In the procedure a conventional balloon is passed through the stenosis which is then dilated. After this patients are randomized before a second dilatation with either a conventional balloon or a drug-coated balloon.

The stenosis is evaluated preoperatively and followed up by means of ultrasound by a vascular technician. Follow-up will end at 12 months. ;

Related Conditions & MeSH terms

• Constriction, Pathologic
• Peripheral Arterial Disease
• Peripheral Artery Occlusive Disease
• Peripheral Artery Restenosis
• Peripheral Artery Stenosis

• NCT number: NCT03023098
• Study type: Interventional
• Source: Helsinki University Central Hospital
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Completion date: November 2016