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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2019-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Coronary Restenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Non-slip element balloon (NSE)

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

Group Type ACTIVE_COMPARATOR

Non-slip element balloon (NSE)

Intervention Type DEVICE

Lacrosse® NSE and SeQuent® Please drug coated balloon (DCB)

Balloon

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

Group Type PLACEBO_COMPARATOR

Balloon

Intervention Type DEVICE

Non-compliant balloon and SeQuent® Please drug coated balloon (DCB)

Interventions

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Non-slip element balloon (NSE)

Lacrosse® NSE and SeQuent® Please drug coated balloon (DCB)

Intervention Type DEVICE

Balloon

Non-compliant balloon and SeQuent® Please drug coated balloon (DCB)

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes