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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034122
Receipt No. R000038612
Scientific Title Multi-center, single arm study for Drug-coated balloon, TCD-17187
Date of disclosure of the study information 2018/10/01
Last modified on 2018/09/13

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Basic information
Public title Multi-center, single arm study for Drug-coated balloon, TCD-17187
Acronym Multi-center, single arm study for Drug-coated balloon, TCD-17187
Scientific Title Multi-center, single arm study for Drug-coated balloon, TCD-17187
Scientific Title:Acronym Multi-center, single arm study for Drug-coated balloon, TCD-17187
Region
Japan

Condition
Condition Superficial femoral and proximal popliteal artery disease
Classification by specialty
Cardiology Vascular surgery Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The study objective is to determine the efficacy and safety of TCD-17187 Drug-Coated Angioplasty Balloon Catheter in the superficial femoral and/or popliteal artery.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Primary patency rate at 1 year post-procedure
Key secondary outcomes Efficacy:
1. Technical success rate
2. Procedure success rate
3. Primary patency rate at 30 days, 6 months, and 2 and 3 years post study procedure.
4. Free from clinically-driven Target Lesion Revascularization (TLR) at 30 days, 6 months, and 1, 2 and 3 years post-procedure.
5. Free from target limb amputation at 30 days, 6 months, and 1, 2 and 3 years post-procedure.
6. Change in Ankle-Brachial Index (ABI) from baseline at discharge, 30 days, 6 months, 1, 2 and 3 years post-procedure.
7. Improvement in Walking Impairment Questionnaire (WIQ) score from baseline at 30 days, 6 months, 1, 2 and 3 years post-procedure.
8. Improvement in Rutherford Clinical Classification (RCC) from baseline at 30 days, 6 months, 1, 2 and 3 years post-procedure.
Safety:
1. Major Adverse Event (MAE) rate, defined as freedom from device- and procedure- related deaths through 30 days, freedom from target limb major amputation, and freedom from clinically driven lesion revascularization assessed at 6 months, 1, 2 and 3 years.
・ device- and procedure-related death through 30 days
・ clinically-driven TLR at 30 days, 6 months, and 1,2 and 3 years
・ Target limb amputation at 30 days, 6 months, and 1,2 and 3 years
2. All-cause mortality at 30 days, 6 months, and 1,2 and 3 years
3. Adverse event rate
4. Serious adverse event rate
5. Device related adverse event rate
6. Study device malfunction.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 TCD-17187 will be used for stenotic or occluded lesions.
Follow-up observation will be done at 30 days, 6 months, 1, 2, and 3 years after index procedure.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria - Symptomatic ischemia requiring treatment of the SFA and/or popliteal artery.
- Rutherford classification of 2-4 in the target limb.
- Those who with de novo lesion, or restenosis lesions with no stent placement (>=70% stenosis) in the SFA or the popliteal artery.
- Target lesion that meets any of the following (occlusion length<=100mm for occlusion lesion):
1) A single lesion with target lesion length of 180mm,
2) Total combined lesion length of <=180mm including <=30mm gap (tandem lesion).
- Reference vessel diameter >=4mm and <=7mm.
- Pre-dilatation was successfully completed. Successful is defined as achieved <50% residual stenosis without flow-limiting arterial dissection. Flow-limiting arterial dissection is defined as Grade D or higher.
Key exclusion criteria - History or complications of renal failure, chronic kidney disease (creatinine >2.5mg/dL), or myocardial infarction within 30 days prior to the procedure.
- Significant gastrointestinal bleeding or any coagulopathy that would contraindicate anti-platelet therapy.
- Contradicted for use of drugs required for PTA treatment, known sensitivity or allergy to paclitaxel, or allergy to contrast materials (unresponsive to pre-treatment with an existing standard antiallergic drug).
- Presence of severe calcification in the target vessel confirmed by angiography prior to study procedure.
- The use of adjunctive therapies (e.g. atherectomy, crosser, laser, cutting/scoring balloons, cryoplasty and re-entry devices) during the target vessel procedure.
- Vascular injuries, such as arterial dissection and perforation, that require stenting prior to enrollment.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name 1)Masato Nakamura, 2)Osamu Iida
Organization 1)Toho University Ohashi Medical Center
2)Kansai Rosai Hospital
Division name 1)Cardiology, 2)Cardiology
Zip code
Address 1) 2-22-36 Ohashi, Meguro-ku, Tokyo, Japan, 2) 3-1-69 Inabaso, Amagasaki, Hyogo, Japan
TEL 1)03-3468-1251.2)06-6416-1221
Email masato@oha.toho-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Seigo Nakano
Organization Terumo Corporation
Division name Clinical Affairs
Zip code
Address Tokyo Opera City Tower 49F, 3-20-2,Nishi-Shinjuku,Shinjuku-ku,Tokyo, Japan
TEL 03-6742-8241
Homepage URL
Email Seigo_Nakano@terumo.co.jp

Sponsor
Institute Terumo Corporation
Institute
Department

Funding Source
Organization Terumo Corporation
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
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

Other administrative information
Date of disclosure of the study information
2018 Year 10 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 Preinitiation
Date of protocol fixation
2018 Year 08 Month 10 Day
Date of IRB
Anticipated trial start date
2018 Year 10 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
2018 Year 09 Month 13 Day
Last modified on
2018 Year 09 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038612

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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