Unique ID issued by UMIN | UMIN000003754 |
---|---|
Receipt number | R000004548 |
Scientific Title | Effectiveness of Paclitaxel-eluting Balloon Catheter in Patients with Sirolimus-eluting Stent Restenosis |
Date of disclosure of the study information | 2010/06/14 |
Last modified on | 2010/06/14 22:45:40 |
Effectiveness of Paclitaxel-eluting Balloon Catheter in Patients with Sirolimus-eluting Stent Restenosis
Paclitaxel-eluting Balloon for SES Restenosis
Effectiveness of Paclitaxel-eluting Balloon Catheter in Patients with Sirolimus-eluting Stent Restenosis
Paclitaxel-eluting Balloon for SES Restenosis
Japan |
coronary artery disease
Cardiology |
Others
NO
The aim of this study was to investigate the efficacy of paclitaxel-eluting balloon (PEB) for the treatment of sirolimus-eluting stent (SES) restenosis.
Efficacy
Confirmatory
Pragmatic
Not applicable
late lumen loss
the rate of binary restenosis and major adverse cardiac events (MACE)
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Numbered container method
2
Treatment
Device,equipment |
Paclitaxel-Eluting PTCA Balloon (SeQuent Please balloon catheter, B. Braun Melsungen AG, Vascular Systems, Berlin, Germany)
conventional balloon
20 | years-old | <= |
Not applicable |
Male and Female
The patients with ISR after SES implantation with clinical evidence of stable angina.
The target lesion had to be the first ISR after SES implantation with the vessel 2.5-3.5mm in diameter.
The lesions in the left main coronary artery, or the ostial, bifurcated, or totally occluded lesions were not regarded as the target lesions.
Patients with acute coronary syndrome, severe renal insufficiency (glomerular filtration rate: <30 ml/min), prior stent implantation within 6 months, severe concomitant systemic illness, and conditions likely to preclude follow-up angiography were excluded.
50
1st name | |
Middle name | |
Last name | Seiji Habara |
Kurashiki Central Hospital
Department of Cardiology
1-1-1 Miwa, kurashiki-shi, Okayama 710-8602, Japan
+81-86-422-0210
1st name | |
Middle name | |
Last name | Seiji Habara |
Kurashiki Central Hospital
Department of Cardiology
1-1-1 Miwa, kurashiki-shi, Okayama 710-8602, Japan
+81-86-422-0210
sh10461@kchnet.or.jp
Kurashiki Central Hospital
none
Self funding
NO
倉敷中央病院(岡山県)
2010 | Year | 06 | Month | 14 | Day |
Unpublished
Completed
2008 | Year | 07 | Month | 08 | Day |
2008 | Year | 09 | Month | 01 | Day |
2010 | Year | 05 | Month | 01 | Day |
2010 | Year | 05 | Month | 01 | Day |
2010 | Year | 05 | Month | 01 | Day |
2010 | Year | 05 | Month | 01 | Day |
2010 | Year | 06 | Month | 14 | Day |
2010 | Year | 06 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004548