UMIN-CTR Clinical Trial

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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

Kurashiki Central Hospital

Institute

Department

Personal name



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

Value
https://center6.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