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

Phase 4

• Conditions: Coronary Restenosis
• Interventions: Device: Balloon; Device: Non-slip element balloon (NSE)

• Registration Number: NCT02300454
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-14
• Study First Submitted QC: 2014-11-20
• Study First Posted: 2014-11-25
• Study Start: 2015-06
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-22
• Last Update Posted: 2017-03-23
• Primary Completion: 2018-04
• Study Completion: 2019-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 210

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Balloon	Balloon	Non-compliant balloon dilatation before use of SeQuent® Please drug coated balloon (DCB)
Non-slip element balloon (NSE)	Non-slip element balloon (NSE)	Lacrosse® NSE dilatation before use of SeQuent® Please drug coated balloon (DCB)

Primary Outcome Measures

Name	Time	Method
Angiographic in-segment late loss	8 months

Secondary Outcome Measures

Name	Time	Method
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	cardiac death, myocardial infarction, target vessel revascularization
the prevalence of stent implantation	within one day
the prevalence of balloon slipping	within one day	more than 3 mm balloon slipping
DCB length	within one day

Trial Locations

Locations (2)

Tokai University; 🇯🇵 Isehara, Kanagawa, Japan

Mitsui Memorial Hospital; 🇯🇵 Chiyoda-Ku, Tokyo, Japan