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Drug-eluting Balloon vs. Conventional Balloon in the Treatment of (re)Stenosis - a Randomized Prospective Study (DRECOREST1)

Primary Purpose

Peripheral Artery Occlusive Disease, Peripheral Artery Restenosis, Peripheral Artery Stenosis

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Conventional PTA
Drug-eluting balloon
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Artery Occlusive Disease focused on measuring Restenosis, Drug-eluting balloon, Vein graft

Eligibility Criteria

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

Inclusion Criteria:

  • Any venous bypass with stenosis warranting intervention

Exclusion Criteria:

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

Sites / Locations

  • Helsinki University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Drug-eluting balloon

Conventional PTA

Arm Description

Outcomes

Primary Outcome Measures

TLR (Target lesion revascularization)
Any reintervention to the same lesion.
Graft occlusion
Occlusion of the bypass graft

Secondary Outcome Measures

Major amputation
Above or below knee amputation of the treated leg
Death

Full Information

First Posted
January 12, 2017
Last Updated
January 13, 2017
Sponsor
Helsinki University Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03023098
Brief Title
Drug-eluting Balloon vs. Conventional Balloon in the Treatment of (re)Stenosis - a Randomized Prospective Study
Acronym
DRECOREST1
Official Title
Drug-eluting Balloon vs. Conventional Balloon in the Treatment of (re)Stenosis - a Randomized Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital

4. Oversight

Data Monitoring Committee
No

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 bypass vein grafts.
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 bypass vein grafts, 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
Peripheral Artery Occlusive Disease, Peripheral Artery Restenosis, Peripheral Artery Stenosis
Keywords
Restenosis, Drug-eluting balloon, Vein graft

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drug-eluting balloon
Arm Type
Experimental
Arm Title
Conventional PTA
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Conventional PTA
Other Intervention Name(s)
PTA (percutaneous transluminal angioplasty), Balloon angioplasty
Intervention Description
After passing the stenosis it is dilated with a conventional balloon. The patient is randomized to a second dilatation with a conventional balloon
Intervention Type
Device
Intervention Name(s)
Drug-eluting balloon
Other Intervention Name(s)
DEB
Intervention Description
After passing the stenosis it is dilated with a conventional balloon. The patient is randomized to a second dilatation with a drug-eluting balloon
Primary Outcome Measure Information:
Title
TLR (Target lesion revascularization)
Description
Any reintervention to the same lesion.
Time Frame
12 months
Title
Graft occlusion
Description
Occlusion of the bypass graft
Time Frame
0-12 months
Secondary Outcome Measure Information:
Title
Major amputation
Description
Above or below knee amputation of the treated leg
Time Frame
0-12 months
Title
Death
Time Frame
0-12 months
Other Pre-specified Outcome Measures:
Title
Primary assisted patency
Description
Patency of the graft after TLR
Time Frame
0-12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Any venous bypass with stenosis warranting intervention Exclusion Criteria: Previous PTA with drug-eluting balloon, thrombolysis, coagulopathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maarit Venermo, M.D., Ph.D.
Organizational Affiliation
Helsinki University Hospital, Dept. of Vascular Surgery
Official's Role
Study Director
Facility Information:
Facility Name
Helsinki University Hospital
City
Helsinki
ZIP/Postal Code
00029
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30092443
Citation
Bjorkman P, Kokkonen T, Alback A, Venermo M. Drug-Coated versus Plain Balloon Angioplasty in Bypass Vein Grafts (the DRECOREST I-Study). Ann Vasc Surg. 2019 Feb;55:36-44. doi: 10.1016/j.avsg.2018.04.042. Epub 2018 Aug 6.
Results Reference
derived

Learn more about this trial

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

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