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| Name | Class |
|---|---|
| Teikyo University | OTHER |
| Tokai University | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-slip element balloon (NSE) | Active Comparator | Lacrosse® NSE dilatation before use of SeQuent® Please drug coated balloon (DCB) |
|
| Balloon | Placebo Comparator | Non-compliant balloon dilatation before use of SeQuent® Please drug coated balloon (DCB) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-slip element balloon (NSE) | Device | Lacrosse® NSE and SeQuent® Please drug coated balloon (DCB) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Angiographic in-segment late loss | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| angiographic minimal lumen diameter | 8 months | |
| minimal lumen area (OCT analysis) | within one day | |
| mean neointimal area (OCT analysis) |
| Measure | Description | Time Frame |
|---|---|---|
| angiographic in-segment late loss | subanalysis: drug eluting stent restenosis | 8 months |
| angiographic in-segment late loss | subanalysis: slipping group |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ai Teramoto | Teikyo Academic Research Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokai University | Isehara | Kanagawa | Japan | |||
| Mitsui Memorial Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33048289 | Derived | 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. |
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| ID | Term |
|---|---|
| D023903 | Coronary Restenosis |
| ID | Term |
|---|---|
| D023921 | Coronary Stenosis |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
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| Balloon | Device | Non-compliant balloon and SeQuent® Please drug coated balloon (DCB) |
|
| 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 |
| 8 months |
| angiographic in-segment late loss | subanalysis: diffuse, occlusive, and proliferative restenosis type | 8 months |
| angiographic in-segment late loss | subanalysis: in-stent re-restenosis lesion | 8 months |
| angiographic in-segment late loss | subanalysis: stent diameter 2.25 or 2.5 mm | 8 months |
| Chiyoda-Ku |
| Tokyo |
| Japan |
| D002318 |
| Cardiovascular Diseases |
| D014652 | Vascular Diseases |