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

March 22, 2017 updated by: Jiro Aoki, Mitsui Memorial Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

210

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Kanagawa
      • Isehara, Kanagawa, Japan
        • Tokai University
    • Tokyo
      • Chiyoda-Ku, Tokyo, Japan
        • Mitsui Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Non-slip element balloon (NSE)
Lacrosse® NSE dilatation before use of SeQuent® Please drug coated balloon (DCB)
Device: Non-slip element balloon (NSE)
Lacrosse® NSE and SeQuent® Please drug coated balloon (DCB)
Placebo Comparator: Balloon
Non-compliant balloon dilatation before use of SeQuent® Please drug coated balloon (DCB)
Device: Balloon
Non-compliant balloon and SeQuent® Please drug coated balloon (DCB)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Angiographic in-segment late loss
Time Frame: 8 months
8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
angiographic minimal lumen diameter
Time Frame: 8 months
8 months
minimal lumen area (OCT analysis)
Time Frame: within one day
within one day
mean neointimal area (OCT analysis)
Time Frame: within one day
within one day
angiographic acute gain
Time Frame: within one day
within one day
Target vessel failure
Time Frame: 8 months and 24 months
cardiac death, myocardial infarction, target vessel revascularization
8 months and 24 months
the prevalence of stent implantation
Time Frame: within one day
within one day
the prevalence of balloon slipping
Time Frame: within one day
more than 3 mm balloon slipping
within one day
DCB length
Time Frame: within one day
within one day

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
angiographic in-segment late loss
Time Frame: 8 months
subanalysis: drug eluting stent restenosis
8 months
angiographic in-segment late loss
Time Frame: 8 months
subanalysis: slipping group
8 months
angiographic in-segment late loss
Time Frame: 8 months
subanalysis: diffuse, occlusive, and proliferative restenosis type
8 months
angiographic in-segment late loss
Time Frame: 8 months
subanalysis: in-stent re-restenosis lesion
8 months
angiographic in-segment late loss
Time Frame: 8 months
subanalysis: stent diameter 2.25 or 2.5 mm
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mitsui Memorial Hospital

Collaborators

Teikyo University
Tokai University

Investigators

  • Study Director: Ai Teramoto, Teikyo Academic Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Anticipated)

April 1, 2018

Study Completion (Anticipated)

April 1, 2019

Study Registration Dates

First Submitted

November 14, 2014

First Submitted That Met QC Criteria

November 20, 2014

First Posted (Estimate)

November 25, 2014

Study Record Updates

Last Update Posted (Actual)

March 23, 2017

Last Update Submitted That Met QC Criteria

March 22, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEC2014-14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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