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

Sponsor
Helsinki University Central Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03036241
Collaborator
(none)
39
Enrollment
2
Arms
49.2
Actual Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Conventional angioplasty
  • Device: Angioplasty with drug-eluting balloon
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
39 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Drug-eluting Balloon vs. Conventional Balloon in the Treatment of (re)Stenosis - a Randomized Prospective Study (Dialysis Fistulae)
Actual Study Start Date :
Jan 23, 2013
Actual Primary Completion Date :
Feb 28, 2017
Actual Study Completion Date :
Feb 28, 2017

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. TLR [12 months]

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

    2. Occlusion of access [12 months]

      Any loss of dialysis access due to thrombosis

    Secondary Outcome Measures

    1. Primary assisted patency [12 months]

      Patency after endovascular reintervention due to restenosis or thrombosis

    2. Death [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Any dialysis access w/ native vessels warranting intervention
    Exclusion Criteria:
    • Previous PTA with drug-eluting balloon, thrombolysis, coagulopathy

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Helsinki University Central Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Maarit Venermo, Professor of Vascular Surgery, Helsinki University Central Hospital
    ClinicalTrials.gov Identifier:
    NCT03036241
    Other Study ID Numbers:
    • DRECOREST2 - 23rd Jan 2013
    First Posted:
    Jan 30, 2017
    Last Update Posted:
    Jun 23, 2017
    Last Verified:
    Jun 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Maarit Venermo, Professor of Vascular Surgery, Helsinki University Central Hospital
    drug-eluting balloon,
    target lesion revascularization (TLR)
    restenosis
    Additional relevant MeSH terms:
    Fistula
    Graft Occlusion, Vascular

    Study Results

    No Results Posted as of Jun 23, 2017