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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

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
Coronary Restenosis Device: Non-slip element balloon (NSE) Device: Balloon Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : June 2015
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2019

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)




Primary Outcome Measures :
  1. Angiographic in-segment late loss [ Time Frame: 8 months ]

Secondary Outcome Measures :
  1. angiographic minimal lumen diameter [ Time Frame: 8 months ]
  2. minimal lumen area (OCT analysis) [ Time Frame: within one day ]
  3. mean neointimal area (OCT analysis) [ Time Frame: within one day ]
  4. angiographic acute gain [ Time Frame: within one day ]
  5. Target vessel failure [ Time Frame: 8 months and 24 months ]
    cardiac death, myocardial infarction, target vessel revascularization

  6. the prevalence of stent implantation [ Time Frame: within one day ]
  7. the prevalence of balloon slipping [ Time Frame: within one day ]
    more than 3 mm balloon slipping

  8. DCB length [ Time Frame: within one day ]

Other Outcome Measures:
  1. angiographic in-segment late loss [ Time Frame: 8 months ]
    subanalysis: drug eluting stent restenosis

  2. angiographic in-segment late loss [ Time Frame: 8 months ]
    subanalysis: slipping group

  3. angiographic in-segment late loss [ Time Frame: 8 months ]
    subanalysis: diffuse, occlusive, and proliferative restenosis type

  4. angiographic in-segment late loss [ Time Frame: 8 months ]
    subanalysis: in-stent re-restenosis lesion

  5. angiographic in-segment late loss [ Time Frame: 8 months ]
    subanalysis: stent diameter 2.25 or 2.5 mm



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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02300454


Locations
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Japan
Tokai University
Isehara, Kanagawa, Japan
Mitsui Memorial Hospital
Chiyoda-Ku, Tokyo, Japan
Sponsors and Collaborators
Mitsui Memorial Hospital
Teikyo University
Tokai University
Investigators
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Study Director: Ai Teramoto Teikyo Academic Research Center

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Responsible Party: Jiro Aoki, Associate Director, Division of Cardiology, Mitsui Memorial Hospital
ClinicalTrials.gov Identifier: NCT02300454     History of Changes
Other Study ID Numbers: MEC2014-14
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: March 23, 2017
Last Verified: March 2017

Keywords provided by Jiro Aoki, Mitsui Memorial Hospital:
in-stent restenosis
percutaneous coronary intervention
balloon

Additional relevant MeSH terms:
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Coronary Restenosis
Coronary Stenosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases