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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title:

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 Summary:
Sponsor: Mitsui Memorial Hospital

Current Primary Outcome: Angiographic in-segment late loss [ Time Frame: 8 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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:

  • 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 ]


Information By: Mitsui Memorial Hospital

Dates:
Date Received: November 14, 2014
Date Started: June 2015
Date Completion: April 2019
Last Updated: March 22, 2017
Last Verified: March 2017