Clinical trial NCT02300454: Effect of Combination of Non-sLip Element Balloon (NSE) and druG-coated bAlloon (DCB) for In-steNT Restenosis Lesions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Restenosis
Keywords: in-stent restenosis
percutaneous coronary intervention
balloon
Lead sponsor: Mitsui Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Teikyo University
name: Tokai University
First posted: 2014-11-25
Enrollment: 210
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Angiographic in-segment late loss
timeFrame: 8 months
Secondary outcomes:
measure: angiographic minimal lumen diameter
timeFrame: 8 months
measure: minimal lumen area (OCT analysis)
timeFrame: within one day
measure: mean neointimal area (OCT analysis)
timeFrame: within one day
measure: angiographic acute gain
timeFrame: within one day
measure: Target vessel failure
timeFrame: 8 months and 24 months
measure: the prevalence of stent implantation
timeFrame: within one day
measure: the prevalence of balloon slipping
timeFrame: within one day
measure: DCB length
timeFrame: within one day
Other outcomes:
measure: angiographic in-segment late loss
timeFrame: 8 months
measure: angiographic in-segment late loss
timeFrame: 8 months
measure: angiographic in-segment late loss
timeFrame: 8 months
measure: angiographic in-segment late loss
timeFrame: 8 months
measure: angiographic in-segment late loss
timeFrame: 8 months
Locations:
city: Isehara
country: Japan
facility: Tokai University
state: Kanagawa
city: Chiyoda-Ku
country: Japan
facility: Mitsui Memorial Hospital
state: Tokyo
Study officials:
affiliation: Teikyo Academic Research Center
name: Ai Teramoto
role: STUDY_DIRECTOR
References:
citation: Aoki J, Nakazawa G, Ando K, Nakamura S, Tobaru T, Sakurada M, Okada H, Hibi K, Zen K, Ikuta A, Fujii K, Habara M, Ako J, Asano T, Ozaki S, Fusazaki T, Kozuma K; ELEGANT investigators. Impact of hemodialysis on clinical and angiographic outcomes in in-stent restenotic lesions following optical coherence tomography-guided drug-coated balloon treatment. Cardiovasc Interv Ther. 2021 Oct;36(4):429-435. doi: 10.1007/s12928-020-00718-7. Epub 2020 Oct 13.