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

Mitsui Memorial Hospital

Status and phase: Unknown; Phase 4

Conditions: Coronary Restenosis

Treatments: Device: Non-slip element balloon (NSE); Device: Balloon

Study type: Interventional

Funder types: Other

Identifiers

NCT02300454

MEC2014-14

Details and patient eligibility

About

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.

Enrollment: 210 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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210 participants in 2 patient groups, including a placebo group

Non-slip element balloon (NSE)

Active Comparator group

Description:

Lacrosse® NSE dilatation before use of SeQuent® Please drug coated balloon (DCB)

Treatment:

Device: Non-slip element balloon (NSE)

Balloon

Placebo Comparator group

Description:

Non-compliant balloon dilatation before use of SeQuent® Please drug coated balloon (DCB)

Treatment:

Device: Balloon