Clinical Trial: Drug-eluting Balloon vs. Conventional Balloon in the Treatment of (re)Stenosis (Dialysis Fistulae)

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

Brief 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 dialysis fistulae.

Detailed Summary:

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 dialysis fistulae 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.

Sponsor: Helsinki University Central Hospital

Current Primary Outcome:

• TLR [ Time Frame: 12 months ]
  Target lesion revascularization, ie. re-intervention to the same lesion
• Occlusion of access [ Time Frame: 12 months ]
  Any loss of dialysis access due to thrombosis

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Primary assisted patency [ Time Frame: 12 months ]
  Patency after endovascular reintervention due to restenosis or thrombosis
• Death [ Time Frame: 12 months ]

Original Secondary Outcome: Same as current

Information By: Helsinki University Central Hospital

Dates:
Date Received: January 19, 2017
Date Started: January 23, 2013
Date Completion: February 28, 2017
Last Updated: January 26, 2017
Last Verified: January 2017