UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043774
Receipt number R000049809
Scientific Title Ranger drug-coated balloon catheters post market surveillance
Date of disclosure of the study information 2021/06/01
Last modified on 2022/03/30 14:42:40

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Basic information

Public title

Ranger drug-coated balloon catheters post market surveillance

Acronym

Ranger drug-coated balloon catheters post market surveillance

Scientific Title

Ranger drug-coated balloon catheters post market surveillance

Scientific Title:Acronym

Ranger drug-coated balloon catheters post market surveillance

Region

Japan


Condition

Condition

Superficial femoral and proximal popliteal artery disease

Classification by specialty

Cardiology Surgery in general Vascular surgery
Radiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this surveillance is to understand the situation of occurrence of failure in order to ensure the safety of the product, as well as to collect data on the safety and efficacy of this product in clinical practice.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

- Implementation rate of target lesion revascularization (TLR)
- Occurrence rate of AE and device malfunction
- Mortality rate

Key secondary outcomes

- Death of any cause and target limb amputation during the follow-up (procedure, pre-discharge, 1, 6, 12 and 24 months) period
- SAE for which relation to the Ranger DCB or procedures cannot be denied during the follow-up period
- Device malfunction and adverse event for which the relation to Ranger DCB or procedures cannot be denied during the follow-up period
- Duration of Ranger DCB related DAPT at pre-procedure and during the follow-up period


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients intended to be treated with Ranger DCB catheter

Key exclusion criteria

Not applicable

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Kazuo
Middle name
Last name Kawahara

Organization

Boston Scientific Japan K.K.

Division name

Clinical Sciences

Zip code

164-0001

Address

4-10-2 Nakano, Nakano-ku, Tokyo, 164-0001 Japan

TEL

03-6853-7500

Email

JapanClinicalTrials@bsci.com


Public contact

Name of contact person

1st name Yuji
Middle name
Last name Kato

Organization

Boston Scientific Japan K.K.

Division name

Clinical Sciences

Zip code

164-0001

Address

4-10-2 Nakano, Nakano-ku, Tokyo, 164-0001 Japan

TEL

03-6853-7500

Homepage URL


Email

JapanClinicalTrials@bsci.com


Sponsor or person

Institute

Boston Scientific Japan K.K.

Institute

Department

Personal name



Funding Source

Organization

Boston Scientific Japan K.K.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Not applicable

Address

Not applicable

Tel

Not applicable

Email

Not applicable


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



Other administrative information

Date of disclosure of the study information

2021 Year 06 Month 01 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

Open public recruiting

Date of protocol fixation

2021 Year 03 Month 16 Day

Date of IRB

2021 Year 06 Month 29 Day

Anticipated trial start date

2021 Year 08 Month 13 Day

Last follow-up date

2024 Year 12 Month 27 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Not applicable


Management information

Registered date

2021 Year 03 Month 29 Day

Last modified on

2022 Year 03 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049809


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name