UMIN-CTR Clinical Trial

Basic information
Public title	Effectiveness of Paclitaxel-eluting Balloon Catheter in Patients with Sirolimus-eluting Stent Restenosis
Acronym	Paclitaxel-eluting Balloon for SES Restenosis
Scientific Title	Effectiveness of Paclitaxel-eluting Balloon Catheter in Patients with Sirolimus-eluting Stent Restenosis
Scientific Title:Acronym	Paclitaxel-eluting Balloon for SES Restenosis
Region	Japan

Condition
Condition	coronary artery disease
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study was to investigate the efficacy of paclitaxel-eluting balloon (PEB) for the treatment of sirolimus-eluting stent (SES) restenosis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	late lumen loss
Key secondary outcomes	the rate of binary restenosis and major adverse cardiac events (MACE)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Paclitaxel-Eluting PTCA Balloon (SeQuent Please balloon catheter, B. Braun Melsungen AG, Vascular Systems, Berlin, Germany)
Interventions/Control_2	conventional balloon
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	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.
Key exclusion criteria	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.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Seiji Habara
Organization	Kurashiki Central Hospital
Division name	Department of Cardiology
Zip code
Address	1-1-1 Miwa, kurashiki-shi, Okayama 710-8602, Japan
TEL	+81-86-422-0210
Email

Public contact
Name of contact person	1st name Middle name Last name Seiji Habara
Organization	Kurashiki Central Hospital
Division name	Department of Cardiology
Zip code
Address	1-1-1 Miwa, kurashiki-shi, Okayama 710-8602, Japan
TEL	+81-86-422-0210
Homepage URL
Email	sh10461@kchnet.or.jp

Sponsor
Institute	Kurashiki Central Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	倉敷中央病院（岡山県）

Other administrative information
Date of disclosure of the study information	2010 Year 06 Month 14 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 07 Month 08 Day
Date of IRB
Anticipated trial start date	2008 Year 09 Month 01 Day
Last follow-up date	2010 Year 05 Month 01 Day
Date of closure to data entry	2010 Year 05 Month 01 Day
Date trial data considered complete	2010 Year 05 Month 01 Day
Date analysis concluded	2010 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date	2010 Year 06 Month 14 Day
Last modified on	2010 Year 06 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004548

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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