UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004031
Receipt No. R000004845
Scientific Title Clinical evaluation of efficacy and safety of paclitaxel-eluting balloon (PEB) for peripheral artery disease patients with femolo-popliteal lesion
Date of disclosure of the study information 2010/08/11
Last modified on 2016/02/12

* 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 Clinical evaluation of efficacy and safety of paclitaxel-eluting balloon (PEB) for peripheral artery disease patients with femolo-popliteal lesion
Acronym Clinical evaluation of PEB for peripheral artery disease patients
(PADPEB study)
Scientific Title Clinical evaluation of efficacy and safety of paclitaxel-eluting balloon (PEB) for peripheral artery disease patients with femolo-popliteal lesion
Scientific Title:Acronym Clinical evaluation of PEB for peripheral artery disease patients
(PADPEB study)
Region
Japan

Condition
Condition Femolo-popliteal artery disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the quantitative angiographic efficacy of percutaneous transluminal angioplasty (PTA) using PEB compared with conventional uncoated balloon (control) in patients with femolo-popliteal artery stenosis or occulusion
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Late lumen loss (difference between minimal lumen diameter post PTA and at 6-month follow-up), evaluated by quantitative angiography
Key secondary outcomes We defined major adverse events (MAE) as deaths from all causes, clinically driven target vessel revascularization (TVR), and unplanned major amputation of the target limb. In both PEB and control groups, secondary outcomes are as follows:
1.MAE at 6-month follow-up
2.Late lumen loss at 6-month follow-up by quantitative intravascular ultrasonography
3.MAE within 24 months after PTA

4.Primary sustained clinical improvement: an improvement of Rutherford classification of one class in surviving patients without amputation and TLR at 30 days, 6, 12, and 24 months after PTA
5.Secondary sustained clinical improvement: an improvement of Rutherford classification of one class in surviving patients without amputation at 30 days, 6, 12, and 24 months after PTA, even when crinically-driven TVR was performed
6.Time to the first clinically-driven target lesion revascularization (TLR ) within 24 months after PTA
7.Technical success of PTA defined as <30% residual stenosis at the target lesion without provisional stenting
8.Technical success of intervention defined as <30% residual stenosis at the target lesion with or without provisional stenting
9.Procedural success defined as technical success of intervention without any procedural complications prior to discharge
10.Number of TLR performed within 24 months

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 balloon
Interventions/Control_2 conventional uncoated 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 (General)
1. Age >= 20 years
2. Patients or patients' legal representatives have given written informed consent.
3. Patients understand and agree to the study duration and required follow-up visits.
4. Patients are definitely diagnosed with ischemic symptomatic arterial disease in femoral-popliteal arteries according to Rutherford class 1, 2, 3, or 4.
5. Life expectancy > 1 year in the investigator's opinion

(Anatomic)
1. Target vessel is located in the superficial femoral artery and/or proximal popliteal artery above the knee.
2. Target lesion is single solitary or adjacent multiple, de novo or restenotic lesion with >=70% diameter stenosis by visual estimate and cumulative lesion length <=15cm.
3. Adjacent multiple lesions are treated as a single target lesion when the cumulative lesion length <=15cm.
4. Only one target lesion per patient is allowed.
5. Reference vessel diameter >=3mm and <=7mm by visual estimate
6. One or more vessel runoffs from the knee joint to the ankle
Key exclusion criteria (General)
When study patients are
1. Unwilling or unlikely to comply with the follow-up schedule
2. Given local or systematic thrombolytic therapy within 48 hours prior to the procedure
3. Allergic to heparin, aspirin, clopidogrel, ticlopidine, cilostazol, and other anticoagulants, antiplatelet therapies, contrast media, and/or paclitaxel
4. Diagnosed as having bleeding diatheses or hypercoagulable states
5. Enrolled in another device, drug, or biologic study whose follow-up period has not completed
6. Pregnant

(Anatomic)
1. Ipsilateral iliac artery lesions with severe stenosis (>=70% by visual estimate) or occlusion which are not treated or have not obtained a successful residual stenosis (<30% by visual estimate)
# Ipsilateral iliac artery lesions must be treated >=30 days prior to patient randomization and target lesion treatment.
2. Ispsilateral iliac artery lesions treated without drug-eluting stent and/or PEB
3. Unsuccessful treatment of any lesions in the contralateral limb
# Contralateral limb lesions must be treated >=30 days prior to patient randomization and target lesion treatment.
4. A second lesion within the target femolo-popliteal artery
5. Failure to cross the true lumen of target lesion with a guidewire
6. Lesions within or adjacent to an aneurysm
7. Acute or subacute thrombus in the target vessel
8. A history of bypass surgery in the target lesion
9. A severe calcification by angiography which leads to a low expectation of successful dilation by balloon
10. Expectation of single treatment difficulty without other alternative therapies such as stent, laser, cutting balloon, and rotablator
# Bail-out stenting is permitted if needed
Target sample size 72

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

Public contact
Name of contact person
1st name
Middle name
Last name Tsuyoshi Goto
Organization Kurashiki Central Hospital
Division name Department of Cardiology
Zip code
Address 1-1-1 Miwa, kurashik, Okayama 710-8602,Japan
TEL +81-86-422-0210
Homepage URL
Email igakuken@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 08 Month 11 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
2010 Year 07 Month 23 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 08 Month 11 Day
Last modified on
2016 Year 02 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004845

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.