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

Sponsor
Mitsui Memorial Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02300454
Collaborator
Teikyo University (Other), Tokai University (Other)
210
Enrollment
2
Locations
2
Arms
46
Duration (Months)
105
Patients Per Site
2.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Non-slip element balloon (NSE)
  • Device: Balloon
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
210 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Study Start Date :
Jun 1, 2015
Anticipated Primary Completion Date :
Apr 1, 2018
Anticipated Study Completion Date :
Apr 1, 2019

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. Angiographic in-segment late loss [8 months]

Secondary Outcome Measures

  1. angiographic minimal lumen diameter [8 months]

  2. minimal lumen area (OCT analysis) [within one day]

  3. mean neointimal area (OCT analysis) [within one day]

  4. angiographic acute gain [within one day]

  5. Target vessel failure [8 months and 24 months]

    cardiac death, myocardial infarction, target vessel revascularization

  6. the prevalence of stent implantation [within one day]

  7. the prevalence of balloon slipping [within one day]

    more than 3 mm balloon slipping

  8. DCB length [within one day]

Other Outcome Measures

  1. angiographic in-segment late loss [8 months]

    subanalysis: drug eluting stent restenosis

  2. angiographic in-segment late loss [8 months]

    subanalysis: slipping group

  3. angiographic in-segment late loss [8 months]

    subanalysis: diffuse, occlusive, and proliferative restenosis type

  4. angiographic in-segment late loss [8 months]

    subanalysis: in-stent re-restenosis lesion

  5. angiographic in-segment late loss [8 months]

    subanalysis: stent diameter 2.25 or 2.5 mm

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tokai University Isehara Kanagawa Japan
2 Mitsui Memorial Hospital Chiyoda-Ku Tokyo Japan

Sponsors and Collaborators

  • Mitsui Memorial Hospital
  • Teikyo University
  • Tokai University

Investigators

  • Study Director: Ai Teramoto, Teikyo Academic Research Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jiro Aoki, Associate Director, Division of Cardiology, Mitsui Memorial Hospital
ClinicalTrials.gov Identifier:
NCT02300454
Other Study ID Numbers:
  • MEC2014-14
First Posted:
Nov 25, 2014
Last Update Posted:
Mar 23, 2017
Last Verified:
Mar 1, 2017
Keywords provided by Jiro Aoki, Associate Director, Division of Cardiology, Mitsui Memorial Hospital
in-stent restenosis
percutaneous coronary intervention
balloon
Additional relevant MeSH terms:
Coronary Restenosis

Study Results

No Results Posted as of Mar 23, 2017