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

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ClinicalTrials.gov Identifier: NCT02300454
Recruitment Status : Unknown
Verified March 2017 by Jiro Aoki, Mitsui Memorial Hospital.
Recruitment status was:  Active, not recruiting
First Posted : November 25, 2014
Last Update Posted : March 23, 2017
Sponsor:
Collaborators:
Teikyo University
Tokai University
Information provided by (Responsible Party):
Jiro Aoki, Mitsui Memorial Hospital

Tracking Information
First Submitted Date  ICMJE November 14, 2014
First Posted Date  ICMJE November 25, 2014
Last Update Posted Date March 23, 2017
Study Start Date  ICMJE June 2015
Estimated Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2014)
Angiographic in-segment late loss [ Time Frame: 8 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 16, 2015)
  • angiographic minimal lumen diameter [ Time Frame: 8 months ]
  • minimal lumen area (OCT analysis) [ Time Frame: within one day ]
  • mean neointimal area (OCT analysis) [ Time Frame: within one day ]
  • angiographic acute gain [ Time Frame: within one day ]
  • Target vessel failure [ Time Frame: 8 months and 24 months ]
    cardiac death, myocardial infarction, target vessel revascularization
  • the prevalence of stent implantation [ Time Frame: within one day ]
  • the prevalence of balloon slipping [ Time Frame: within one day ]
    more than 3 mm balloon slipping
  • DCB length [ Time Frame: within one day ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2014)
  • angiographic minimal lumen diameter [ Time Frame: 8 months ]
  • minimal lumen area (OCT analysis) [ Time Frame: 8 months ]
  • mean neointimal area (OCT analysis) [ Time Frame: 8 months ]
  • angiographic acute gain [ Time Frame: within one day ]
  • Target vessel failure [ Time Frame: 8 months and 24 months ]
    cardiac death, myocardial infarction, target vessel revascularization
  • the prevalence of stent implantation [ Time Frame: within one day ]
  • the prevalence of balloon slipping [ Time Frame: within one day ]
    more than 3 mm balloon slipping
  • DCB length [ Time Frame: within one day ]
Current Other Pre-specified Outcome Measures
 (submitted: November 20, 2014)
  • angiographic in-segment late loss [ Time Frame: 8 months ]
    subanalysis: drug eluting stent restenosis
  • angiographic in-segment late loss [ Time Frame: 8 months ]
    subanalysis: slipping group
  • angiographic in-segment late loss [ Time Frame: 8 months ]
    subanalysis: diffuse, occlusive, and proliferative restenosis type
  • angiographic in-segment late loss [ Time Frame: 8 months ]
    subanalysis: in-stent re-restenosis lesion
  • angiographic in-segment late loss [ Time Frame: 8 months ]
    subanalysis: stent diameter 2.25 or 2.5 mm
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effect of Combination of Non-sLip Element Balloon (NSE) and druG-coated bAlloon (DCB) for In-steNT Restenosis Lesions
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Coronary Restenosis
Intervention  ICMJE
  • Device: Non-slip element balloon (NSE)
    Lacrosse® NSE and SeQuent® Please drug coated balloon (DCB)
  • Device: Balloon
    Non-compliant balloon and SeQuent® Please drug coated balloon (DCB)
Study Arms  ICMJE
  • Active Comparator: Non-slip element balloon (NSE)
    Lacrosse® NSE dilatation before use of SeQuent® Please drug coated balloon (DCB)
    Intervention: Device: Non-slip element balloon (NSE)
  • Placebo Comparator: Balloon
    Non-compliant balloon dilatation before use of SeQuent® Please drug coated balloon (DCB)
    Intervention: Device: Balloon
Publications * 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. 2020 Oct 13. doi: 10.1007/s12928-020-00718-7. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: March 22, 2017)
210
Original Estimated Enrollment  ICMJE
 (submitted: November 20, 2014)
200
Estimated Study Completion Date  ICMJE April 2019
Estimated Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02300454
Other Study ID Numbers  ICMJE MEC2014-14
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jiro Aoki, Mitsui Memorial Hospital
Study Sponsor  ICMJE Mitsui Memorial Hospital
Collaborators  ICMJE
  • Teikyo University
  • Tokai University
Investigators  ICMJE
Study Director: Ai Teramoto Teikyo Academic Research Center
PRS Account Mitsui Memorial Hospital
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP