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Effect of Combination of Non-sLip Element Balloon (NSE) and druG-coated bAlloon (DCB) for In-steNT Restenosis Lesions (ELEGANT)

Primary Purpose

Coronary Restenosis

Status
Unknown status
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Non-slip element balloon (NSE)
Balloon
Sponsored by
Mitsui Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Restenosis focused on measuring in-stent restenosis, percutaneous coronary intervention, balloon

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • patients with in-stent restenosis lesions who are planned to be treated with drug coating balloon

Exclusion Criteria:

  • ST elevation myocardial infarction
  • stent thrombosis
  • severe renal dysfunction (eGFR <30 ml/min) except dialysis
  • pregnancy
  • planned surgery within 3 months
  • shock vital

Sites / Locations

  • Tokai University
  • Mitsui Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Non-slip element balloon (NSE)

Balloon

Arm Description

Lacrosse® NSE dilatation before use of SeQuent® Please drug coated balloon (DCB)

Non-compliant balloon dilatation before use of SeQuent® Please drug coated balloon (DCB)

Outcomes

Primary Outcome Measures

Angiographic in-segment late loss

Secondary Outcome Measures

angiographic minimal lumen diameter
minimal lumen area (OCT analysis)
mean neointimal area (OCT analysis)
angiographic acute gain
Target vessel failure
cardiac death, myocardial infarction, target vessel revascularization
the prevalence of stent implantation
the prevalence of balloon slipping
more than 3 mm balloon slipping
DCB length

Full Information

First Posted
November 14, 2014
Last Updated
March 22, 2017
Sponsor
Mitsui Memorial Hospital
Collaborators
Teikyo University, Tokai University
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1. Study Identification

Unique Protocol Identification Number
NCT02300454
Brief Title
Effect of Combination of Non-sLip Element Balloon (NSE) and druG-coated bAlloon (DCB) for In-steNT Restenosis Lesions
Acronym
ELEGANT
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
April 2018 (Anticipated)
Study Completion Date
April 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mitsui Memorial Hospital
Collaborators
Teikyo University, Tokai University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Use of SeQuent® Please drug coated balloon (DCB) is effective to treat patients with in-stent restenosis (ISR). However, whether the type of pre-dilatation balloon prior to DCB dilatation impacts on clinical and angiographic outcomes or not is unknown. Lacrosse® Non-slip element balloon (NSE) is a balloon catheter with 3 longitudinal plastic elements which are attached to proximal and distal balloon edges. NSE is developed to incise neointimal tissue and avoid balloon slippage without vitiating balloon derivability and crossability. We investigated angiographic and clinical outcomes following normal non-compliant balloon or NSE dilatation prior to DCB dilatation in ISR lesions.This study is a single blinded, multicenter, randomized trial. Total 200 patients with ISR are randomly assigned to treat with non-compliant balloon or NSE before DCB dilatation. Optical coherence tomographic (OCT) analysis are performed before pre-dilatation and after DCB dilatation Follow-up angiography analysis are planned at 8 months in all patients. Clinical follow-up is planned at 8 and 24 months.Primary endpoint is angiographic in-segment late loss at 8 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Restenosis
Keywords
in-stent restenosis, percutaneous coronary intervention, balloon

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
210 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-slip element balloon (NSE)
Arm Type
Active Comparator
Arm Description
Lacrosse® NSE dilatation before use of SeQuent® Please drug coated balloon (DCB)
Arm Title
Balloon
Arm Type
Placebo Comparator
Arm Description
Non-compliant balloon dilatation before use of SeQuent® Please drug coated balloon (DCB)
Intervention Type
Device
Intervention Name(s)
Non-slip element balloon (NSE)
Intervention Description
Lacrosse® NSE and SeQuent® Please drug coated balloon (DCB)
Intervention Type
Device
Intervention Name(s)
Balloon
Intervention Description
Non-compliant balloon and SeQuent® Please drug coated balloon (DCB)
Primary Outcome Measure Information:
Title
Angiographic in-segment late loss
Time Frame
8 months
Secondary Outcome Measure Information:
Title
angiographic minimal lumen diameter
Time Frame
8 months
Title
minimal lumen area (OCT analysis)
Time Frame
within one day
Title
mean neointimal area (OCT analysis)
Time Frame
within one day
Title
angiographic acute gain
Time Frame
within one day
Title
Target vessel failure
Description
cardiac death, myocardial infarction, target vessel revascularization
Time Frame
8 months and 24 months
Title
the prevalence of stent implantation
Time Frame
within one day
Title
the prevalence of balloon slipping
Description
more than 3 mm balloon slipping
Time Frame
within one day
Title
DCB length
Time Frame
within one day
Other Pre-specified Outcome Measures:
Title
angiographic in-segment late loss
Description
subanalysis: drug eluting stent restenosis
Time Frame
8 months
Title
angiographic in-segment late loss
Description
subanalysis: slipping group
Time Frame
8 months
Title
angiographic in-segment late loss
Description
subanalysis: diffuse, occlusive, and proliferative restenosis type
Time Frame
8 months
Title
angiographic in-segment late loss
Description
subanalysis: in-stent re-restenosis lesion
Time Frame
8 months
Title
angiographic in-segment late loss
Description
subanalysis: stent diameter 2.25 or 2.5 mm
Time Frame
8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: patients with in-stent restenosis lesions who are planned to be treated with drug coating balloon Exclusion Criteria: ST elevation myocardial infarction stent thrombosis severe renal dysfunction (eGFR <30 ml/min) except dialysis pregnancy planned surgery within 3 months shock vital
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ai Teramoto
Organizational Affiliation
Teikyo Academic Research Center
Official's Role
Study Director
Facility Information:
Facility Name
Tokai University
City
Isehara
State/Province
Kanagawa
Country
Japan
Facility Name
Mitsui Memorial Hospital
City
Chiyoda-Ku
State/Province
Tokyo
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
33048289
Citation
Aoki J, Nakazawa G, Ando K, Nakamura S, Tobaru T, Sakurada M, Okada H, Hibi K, Zen K, Ikuta A, Fujii K, Habara M, Ako J, Asano T, Ozaki S, Fusazaki T, Kozuma K; ELEGANT investigators. Impact of hemodialysis on clinical and angiographic outcomes in in-stent restenotic lesions following optical coherence tomography-guided drug-coated balloon treatment. Cardiovasc Interv Ther. 2021 Oct;36(4):429-435. doi: 10.1007/s12928-020-00718-7. Epub 2020 Oct 13.
Results Reference
derived

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Effect of Combination of Non-sLip Element Balloon (NSE) and druG-coated bAlloon (DCB) for In-steNT Restenosis Lesions

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