NCT02300454

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
210

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2015

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 25, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

March 23, 2017

Status Verified

March 1, 2017

Enrollment Period

2.8 years

First QC Date

November 14, 2014

Last Update Submit

March 22, 2017

Conditions

Coronary Restenosis

Keywords

in-stent restenosispercutaneous coronary interventionballoon

Outcome Measures

Primary Outcomes (1)

  • Angiographic in-segment late loss

    8 months

Secondary Outcomes (8)

  • angiographic minimal lumen diameter

    8 months

  • minimal lumen area (OCT analysis)

    within one day

  • mean neointimal area (OCT analysis)

    within one day

  • angiographic acute gain

    within one day

  • Target vessel failure

    8 months and 24 months

  • +3 more secondary outcomes

Other Outcomes (5)

  • angiographic in-segment late loss

    8 months

  • angiographic in-segment late loss

    8 months

  • angiographic in-segment late loss

    8 months

  • +2 more other outcomes

Study Arms (2)

Non-slip element balloon (NSE)

ACTIVE COMPARATOR

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

Device: Non-slip element balloon (NSE)

Balloon

PLACEBO COMPARATOR

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

Device: Balloon

Interventions

Non-slip element balloon (NSE)DEVICE

Lacrosse® NSE and SeQuent® Please drug coated balloon (DCB)

Non-slip element balloon (NSE)
BalloonDEVICE

Non-compliant balloon and SeQuent® Please drug coated balloon (DCB)

Balloon

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tokai University

Isehara, Kanagawa, Japan

Location

Mitsui Memorial Hospital

Chiyoda-Ku, Tokyo, Japan

Location

Related Publications (1)

  • 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.

    PMID: 33048289DERIVED

MeSH Terms

Conditions

Coronary Restenosis

Condition Hierarchy (Ancestors)

Coronary StenosisCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Ai Teramoto

    Teikyo Academic Research Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Director, Division of Cardiology

Study Record Dates

First Submitted

November 14, 2014

First Posted

November 25, 2014

Study Start

June 1, 2015

Primary Completion

April 1, 2018

Study Completion

April 1, 2019

Last Updated

March 23, 2017

Record last verified: 2017-03

Locations

JP(2)