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Drug-eluting Balloon vs. Conventional Balloon in the Treatment of (re)Stenosis (Dialysis Fistulae) (DRECOREST2)

Primary Purpose

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

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Conventional angioplasty

Angioplasty with drug-eluting balloon

About this trial

This is an interventional treatment trial for Vascular Access Complication focused on measuring drug-eluting balloon,, target lesion revascularization (TLR), restenosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Any dialysis access w/ native vessels warranting intervention

Exclusion Criteria:

Previous PTA with drug-eluting balloon, thrombolysis, coagulopathy

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Drug-eluting balloon

Conventional angioplasty

Arm Description

Outcomes

Primary Outcome Measures

TLR

Target lesion revascularization, ie. re-intervention to the same lesion

Occlusion of access

Any loss of dialysis access due to thrombosis

Secondary Outcome Measures

Primary assisted patency

Patency after endovascular reintervention due to restenosis or thrombosis

Death

Full Information

NCT ID

NCT03036241

First Posted

January 19, 2017

Last Updated

June 22, 2017

Sponsor

Helsinki University Central Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03036241

Brief Title

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

Acronym

DRECOREST2

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

January 23, 2013 (Actual)

Primary Completion Date

February 28, 2017 (Actual)

Study Completion Date

February 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Helsinki University Central Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

drug-eluting balloon,, target lesion revascularization (TLR), restenosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

39 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Drug-eluting balloon

Arm Type

Experimental

Arm Title

Conventional angioplasty

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

Conventional angioplasty

Other Intervention Name(s)

PTA

Intervention Description

Angioplasty with conventional balloon

Intervention Type

Device

Intervention Name(s)

Angioplasty with drug-eluting balloon

Other Intervention Name(s)

DEB

Intervention Description

Angioplasty with drug-eluting balloon

Primary Outcome Measure Information:

Title

TLR

Description

Target lesion revascularization, ie. re-intervention to the same lesion

Time Frame

12 months

Title

Occlusion of access

Description

Any loss of dialysis access due to thrombosis

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Primary assisted patency

Description

Patency after endovascular reintervention due to restenosis or thrombosis

Time Frame

12 months

Title

Death

Time Frame

12 months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Any dialysis access w/ native vessels warranting intervention Exclusion Criteria: Previous PTA with drug-eluting balloon, thrombolysis, coagulopathy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maarit Venermo, Prof

Organizational Affiliation

Helsinki University Hospital, dept of vascular surgery

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30182815

Citation

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.

Results Reference

derived

Learn more about this trial

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

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