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

NCT ID: NCT03036241

Last Updated: 2017-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-23
• Study Completion Date: 2017-02-28

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 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 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.

Conditions

Vascular Access Complication; Restenosis, Vascular Graft; Dialysis Related Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Drug-eluting balloon

Group Type: EXPERIMENTAL

Angioplasty with drug-eluting balloon

Intervention Type: DEVICE

Angioplasty with drug-eluting balloon

Conventional angioplasty

Group Type: ACTIVE_COMPARATOR

Conventional angioplasty

Intervention Type: DEVICE

Angioplasty with conventional balloon

Interventions

Conventional angioplasty

Angioplasty with conventional balloon

Intervention Type: DEVICE

Angioplasty with drug-eluting balloon

Angioplasty with drug-eluting balloon

Intervention Type: DEVICE

Other Intervention Names

PTA; DEB

Eligibility Criteria

Inclusion Criteria

• Any dialysis access w/ native vessels warranting intervention

Exclusion Criteria

• Previous PTA with drug-eluting balloon, thrombolysis, coagulopathy

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helsinki University Central Hospital

OTHER

Sponsor Role: lead

Responsible Party

Maarit Venermo

Professor of Vascular Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maarit Venermo, Prof

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Hospital, dept of vascular surgery

References

Bjorkman P, Weselius EM, Kokkonen T, Rauta V, Alback A, Venermo M. Drug-Coated Versus Plain Balloon Angioplasty In Arteriovenous Fistulas: A Randomized, Controlled Study With 1-Year Follow-Up (The Drecorest Ii-Study). Scand J Surg. 2019 Mar;108(1):61-66. doi: 10.1177/1457496918798206. Epub 2018 Sep 5.

Reference Type: DERIVED

PMID: 30182815 (View on PubMed)

Other Identifiers

DRECOREST2 - 23rd Jan 2013

Identifier Type: -

Identifier Source: org_study_id