Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE January 19, 2017
First Posted Date  ICMJE January 30, 2017
Last Update Posted Date June 23, 2017
Actual Study Start Date  ICMJE January 23, 2013
Actual Primary Completion Date February 28, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2017)
  • TLR [ Time Frame: 12 months ]
    Target lesion revascularization, ie. re-intervention to the same lesion
  • Occlusion of access [ Time Frame: 12 months ]
    Any loss of dialysis access due to thrombosis
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2017)
  • Primary assisted patency [ Time Frame: 12 months ]
    Patency after endovascular reintervention due to restenosis or thrombosis
  • Death [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Drug-eluting Balloon vs. Conventional Balloon in the Treatment of (re)Stenosis (Dialysis Fistulae)
Official Title  ICMJE Drug-eluting Balloon vs. Conventional Balloon in the Treatment of (re)Stenosis - a Randomized Prospective Study (Dialysis Fistulae)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Vascular Access Complication
  • Restenosis, Vascular Graft
  • Dialysis Related Complications
Intervention  ICMJE
  • Device: Conventional angioplasty
    Angioplasty with conventional balloon
    Other Name: PTA
  • Device: Angioplasty with drug-eluting balloon
    Angioplasty with drug-eluting balloon
    Other Name: DEB
Study Arms  ICMJE
  • Experimental: Drug-eluting balloon
    Intervention: Device: Angioplasty with drug-eluting balloon
  • Active Comparator: Conventional angioplasty
    Intervention: Device: Conventional angioplasty
Publications * Björkman P, Weselius EM, Kokkonen T, Rauta V, Albäck 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 22, 2017)
39
Original Estimated Enrollment  ICMJE
 (submitted: January 26, 2017)
70
Actual Study Completion Date  ICMJE February 28, 2017
Actual Primary Completion Date February 28, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Any dialysis access w/ native vessels warranting intervention

Exclusion Criteria:

  • Previous PTA with drug-eluting balloon, thrombolysis, coagulopathy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03036241
Other Study ID Numbers  ICMJE DRECOREST2 - 23rd Jan 2013
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Maarit Venermo, Helsinki University Central Hospital
Study Sponsor  ICMJE Helsinki University Central Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Maarit Venermo, Prof Helsinki University Hospital, dept of vascular surgery
PRS Account Helsinki University Central Hospital
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP