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DEB ( Drug Eluting Balloon) in Crural Arteries and Critical Limb Ischemia

Primary Purpose

Peripheral Vascular Diseases

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
DEB
POBA
Sponsored by
Skane University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Vascular Diseases

Eligibility Criteria

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

Inclusion Criteria:

  • Critical limb ischemia. Rutherford class 4-6
  • Crural disease, long lesions, more than 2 cm.
  • Life expectancy > 1year
  • > 18 years

Exclusion Criteria:

  • Pregnancy
  • Patients disapproval
  • Allergy to drug or contrast

Sites / Locations

  • Vascular center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Drug eluting balloon angioplasty

Plain old balloon angioplasty

Arm Description

Intervention with DEB angioplasty in long lesions of crural arteries

Intervention with plain old balloon angioplasty POBA in long lesions of crural arteries

Outcomes

Primary Outcome Measures

Primary patency of treated crural vessels
Evaluation with MRA (Magnetic Resonans Angiography) at 12 months, regarding binary restenosis or occlusion in the treated arterial segment. Proportion of treated segments that remains open.
Clinical driven target lesion revascularization (TLR)
Porportion of patients that needs retreatment in in the monitored arterial segment

Secondary Outcome Measures

Full Information

First Posted
January 19, 2016
Last Updated
December 29, 2022
Sponsor
Skane University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02750605
Brief Title
DEB ( Drug Eluting Balloon) in Crural Arteries and Critical Limb Ischemia
Official Title
Randomized Trial Comparing Drug Coated Balloon vs Plain Balloon Angioplasty in Critical Limb Ischemia and Treatment of Long Lesions in Crural Arteries
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
August 30, 2022 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this trial is to compare short- medium long-term results in treatment of PAD (peripheral arterial disease) in the crural arteries with either drug coated balloon or conventional balloons in a prospective , randomized, single center study Results will be defined as: Limb salvage, Event-free survival, Freedom from TLR (target lesion revascularization), Primary patency, Clinical success, Serious adverse events, and the patients will be followed-up for 1 years. Primary endpoints: Primary Patency at 12 months, TLR (clinical driven), Secondary endpoints: Event free survival, Clinical success at 6,12 months, Technical success, Serious adverse events,

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Vascular Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drug eluting balloon angioplasty
Arm Type
Experimental
Arm Description
Intervention with DEB angioplasty in long lesions of crural arteries
Arm Title
Plain old balloon angioplasty
Arm Type
Active Comparator
Arm Description
Intervention with plain old balloon angioplasty POBA in long lesions of crural arteries
Intervention Type
Device
Intervention Name(s)
DEB
Intervention Description
Intervention with drug eluting balloon.
Intervention Type
Device
Intervention Name(s)
POBA
Intervention Description
Intervention with old technology as comparison
Primary Outcome Measure Information:
Title
Primary patency of treated crural vessels
Description
Evaluation with MRA (Magnetic Resonans Angiography) at 12 months, regarding binary restenosis or occlusion in the treated arterial segment. Proportion of treated segments that remains open.
Time Frame
12 months
Title
Clinical driven target lesion revascularization (TLR)
Description
Porportion of patients that needs retreatment in in the monitored arterial segment
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Critical limb ischemia. Rutherford class 4-6 Crural disease, long lesions, more than 2 cm. Life expectancy > 1year > 18 years Exclusion Criteria: Pregnancy Patients disapproval Allergy to drug or contrast
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Torbjörn Fransson
Organizational Affiliation
SUS, Malmö
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vascular center
City
Malmö
ZIP/Postal Code
23594
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

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DEB ( Drug Eluting Balloon) in Crural Arteries and Critical Limb Ischemia

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