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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03036241
Recruitment Status : Completed
First Posted : January 30, 2017
Last Update Posted : June 23, 2017
Sponsor:
Information provided by (Responsible Party):
Maarit Venermo, Helsinki University Central Hospital

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
Vascular Access Complication Restenosis, Vascular Graft Dialysis Related Complications Device: Conventional angioplasty Device: Angioplasty with drug-eluting balloon Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
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 : January 23, 2013
Actual Primary Completion Date : February 28, 2017
Actual Study Completion Date : February 28, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Drug-eluting balloon Device: Angioplasty with drug-eluting balloon
Angioplasty with drug-eluting balloon
Other Name: DEB

Active Comparator: Conventional angioplasty Device: Conventional angioplasty
Angioplasty with conventional balloon
Other Name: PTA




Primary Outcome Measures :
  1. TLR [ Time Frame: 12 months ]
    Target lesion revascularization, ie. re-intervention to the same lesion

  2. Occlusion of access [ Time Frame: 12 months ]
    Any loss of dialysis access due to thrombosis


Secondary Outcome Measures :
  1. Primary assisted patency [ Time Frame: 12 months ]
    Patency after endovascular reintervention due to restenosis or thrombosis

  2. Death [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any dialysis access w/ native vessels warranting intervention

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03036241


Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
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Principal Investigator: Maarit Venermo, Prof Helsinki University Hospital, dept of vascular surgery

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Maarit Venermo, Professor of Vascular Surgery, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT03036241     History of Changes
Other Study ID Numbers: DRECOREST2 - 23rd Jan 2013
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: June 23, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Maarit Venermo, Helsinki University Central Hospital:
drug-eluting balloon,
target lesion revascularization (TLR)
restenosis

Additional relevant MeSH terms:
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Fistula
Graft Occlusion, Vascular
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes