Coronary Restenosis
Conditions
Keywords
in-stent restenosis, percutaneous coronary intervention, balloon
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.
Interventions
DEVICENon-slip element balloon (NSE)
Lacrosse® NSE and SeQuent® Please drug coated balloon (DCB)
DEVICEBalloon
Non-compliant balloon and SeQuent® Please drug coated balloon (DCB)
Sponsors
Teikyo University
Tokai University
Mitsui Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Angiographic in-segment late loss | 8 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 | — |
| Target vessel failure | 8 months and 24 months | cardiac death, myocardial infarction, target vessel revascularization |
Other
| Measure | Time frame | Description |
|---|---|---|
| angiographic in-segment late loss | 8 months | subanalysis: drug eluting stent restenosis |
Countries
Japan
Outcome results
None listed