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

June 22, 2017 updated by: Maarit Venermo, Helsinki University Central Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Any dialysis access w/ native vessels warranting intervention

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Drug-eluting balloon
Device: Angioplasty with drug-eluting balloon
Angioplasty with drug-eluting balloon
Other Names:
  • DEB
Active Comparator: Conventional angioplasty
Device: Conventional angioplasty
Angioplasty with conventional balloon
Other Names:
  • PTA

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death
Time Frame: 12 months
12 months
Primary assisted patency
Time Frame: 12 months
Patency after endovascular reintervention due to restenosis or thrombosis
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Investigators

  • Principal Investigator: Maarit Venermo, Prof, Helsinki University Hospital, dept of vascular surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2013

Primary Completion (Actual)

February 28, 2017

Study Completion (Actual)

February 28, 2017

Study Registration Dates

First Submitted

January 19, 2017

First Submitted That Met QC Criteria

January 26, 2017

First Posted (Estimate)

January 30, 2017

Study Record Updates

Last Update Posted (Actual)

June 23, 2017

Last Update Submitted That Met QC Criteria

June 22, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DRECOREST2 - 23rd Jan 2013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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