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

Coronary Restenosis Clinical Trial

— ELEGANT  

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02300454
• Other study ID #: MEC2014-14
• Status: Active, not recruiting
• Phase: Phase 4
• First received: November 14, 2014
• Last updated: March 22, 2017
• Start date: June 2015
• Est. completion date: April 2019

Study information

• Verified date: March 2017
• Source: Mitsui Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 210
• Est. completion date: April 2019
• Est. primary completion date: April 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Restenosis

Intervention

Device:
• Non-slip element balloon (NSE)
Lacrosse® NSE and SeQuent® Please drug coated balloon (DCB)
• Balloon
Non-compliant balloon and SeQuent® Please drug coated balloon (DCB)

Locations

Country	Name	City	State
Japan	Mitsui Memorial Hospital	Chiyoda-Ku	Tokyo
Japan	Tokai University	Isehara	Kanagawa

Sponsors (3)

Lead Sponsor	Collaborator
Mitsui Memorial Hospital	Teikyo University, Tokai University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	angiographic in-segment late loss	subanalysis: drug eluting stent restenosis	8 months
Other	angiographic in-segment late loss	subanalysis: slipping group	8 months
Other	angiographic in-segment late loss	subanalysis: diffuse, occlusive, and proliferative restenosis type	8 months
Other	angiographic in-segment late loss	subanalysis: in-stent re-restenosis lesion	8 months
Other	angiographic in-segment late loss	subanalysis: stent diameter 2.25 or 2.5 mm	8 months
Primary	Angiographic in-segment late loss		8 months
Secondary	angiographic minimal lumen diameter		8 months
Secondary	minimal lumen area (OCT analysis)		within one day
Secondary	mean neointimal area (OCT analysis)		within one day
Secondary	angiographic acute gain		within one day
Secondary	Target vessel failure	cardiac death, myocardial infarction, target vessel revascularization	8 months and 24 months
Secondary	the prevalence of stent implantation		within one day
Secondary	the prevalence of balloon slipping	more than 3 mm balloon slipping	within one day
Secondary	DCB length		within one day