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

Study Overview
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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.

Conditions
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Coronary Restenosis

Intervention / Treatment
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* Device: Non-slip element balloon (NSE)
* Device: Balloon


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Non-slip element balloon (NSE)<br>Lacrosse® NSE dilatation before use of SeQuent® Please drug coated balloon (DCB) | Device: Non-slip element balloon (NSE)<br>* Lacrosse® NSE and SeQuent® Please drug coated balloon (DCB)<br>|
| Placebo Comparator: Balloon<br>Non-compliant balloon dilatation before use of SeQuent® Please drug coated balloon (DCB) | Device: Balloon<br>* Non-compliant balloon and SeQuent® Please drug coated balloon (DCB)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Angiographic in-segment late loss |  | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | cardiac death, myocardial infarction, target vessel revascularization | 8 months and 24 months | 
| the prevalence of stent implantation |  | within one day | 
| the prevalence of balloon slipping | more than 3 mm balloon slipping | within one day | 
| DCB length |  | within one day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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in-stent restenosis, percutaneous coronary intervention, balloon