Unique ID issued by UMIN | UMIN000016726 |
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Receipt number | R000018192 |
Scientific Title | Safety and efficacy of a bioresorbable vascular scaffold for the side branch in coronary bifurcation lesions: A clinical feasibility trial |
Date of disclosure of the study information | 2015/03/08 |
Last modified on | 2018/09/05 11:34:41 |
Safety and efficacy of a bioresorbable vascular scaffold for the side branch in coronary bifurcation lesions: A clinical feasibility trial
A bioresorbable vascular scaffold
for the side branch in coronary bifurcation lesions
Safety and efficacy of a bioresorbable vascular scaffold for the side branch in coronary bifurcation lesions: A clinical feasibility trial
A bioresorbable vascular scaffold
for the side branch in coronary bifurcation lesions
Japan |
Coronary artery disease with bifurcation lesions
Cardiology |
Others
NO
To collect cases of bioresorbable vascular scaffold (BVS) implantation using provisional stenting in the side branch of coronary bifurcation lesions and preliminary assess the safety and efficacy of BVS in comparison with the historical data of two-stent strategy
Safety,Efficacy
The late loss of the side branch in bifurcation at 8 and 20 months after PCI.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Device,equipment |
Everolimus-eluting BVS (Absorb, Abbott Vascular)
20 | years-old | <= |
Not applicable |
Male and Female
(1) Patients or substitute decision-makers willing to provide written informed consent, which is approved by the Institutional Review Board or its equivalence
(2) Patients eligible for percutaneous coronary intervention
(3) Patients with coronary bifurcation stenosis
(4) Patients with the necessity of stenting
in the side branch after kissing balloon technique during provisional stenting
(5) Visually estimated target lesion reference vessel diameter, 2.5-3.75mm and lesion length,<=24 mm in the side branch
(6) Patients who can take double antiplatelet agents for 12 months
(1)Unable to be followed up by the implementing medical institution
(2)Life expectancy <2 years
(3)Allergic or contraindicative to the materials used for BVS
(4)Scheduled for elective treatment requiring antiplatelet drug withdrawal
(5)Possibility of pregnancy or lactation
(6)Deemed as unsuitable by the investigator or sub-investigator
100
1st name | |
Middle name | |
Last name | Yasushi Fuku |
Public interest incorporated foundation Ohara HealthCare Foundation
Kurashiki Central Hospital
Department of Cardiology
1-1-1, Miwa, Kurashiki, Okayama
086-422-0210
fuku@kchnet.or.jp
1st name | |
Middle name | |
Last name | Yasushi Fuku |
Public interest incorporated foundation Ohara HealthCare Foundation
Department of Cardiology
1-1-1, Miwa, Kurashiki, Okayama
086-422-0210
fuku@kchnet.or.jp
Public interest incorporated foundation Ohara HealthCare Foundation
Kurashiki Central Hospital
Department of Cardiology
Public interest incorporated foundation Ohara HealthCare Foundation
Kurashiki Central Hospital
Department of Cardiology
Self funding
NO
2015 | Year | 03 | Month | 08 | Day |
Unpublished
Completed
2014 | Year | 11 | Month | 05 | Day |
2015 | Year | 03 | Month | 09 | Day |
2015 | Year | 03 | Month | 06 | Day |
2018 | Year | 09 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018192
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