UMIN-CTR Clinical Trial

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

Superficial femoral and proximal popliteal artery disease

Classification by specialty

Cardiology	Vascular surgery	Radiology

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

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

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

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

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)Osaka Police Hospital

Division name

1)Cardiology, 2)Cardiology

Zip code

-

Address

1) 2-22-36 Ohashi, Meguro-ku, Tokyo, Japan, 2) 10-31 Kitayama-cho, Tennouji-ku, Osaka-city, Osaka, Japan

TEL

1)03-3468-1251.2)06-6771-6051

Email

masato@oha.toho-u.ac.jp

Name of contact person

1st name	Seigo
Middle name
Last name	Nakano

Organization

Terumo Corporation

Division name

Clinical Affairs

Zip code

163-1450

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

Institute

Terumo Corporation

Institute

Department

Personal name

Organization

Terumo Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

-

Address

-

Tel

-

Email

-

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

10

Month

01

Day

URL releasing protocol

Publication of results

Partially published

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/36177551/

Number of participants that the trial has enrolled

121

Results

Age was 74.5+/-7.3 years and the diabetes mellitus was 67.5%. Lesion length and vessel diameter were 106.0+/-52.6 and 5.2+/-0.8 mm, respectively. The CTO and bilateral calcification were 17.5% and 50.8%, respectively. The 12-month primary patency by K-M was 81.1%, while 12-month freedom from CD-TLR was 95.8%. The MAE at 30 days was 1.7% and all events comprised CD-TLR. There were no instances of device- or procedure-related deaths, major amputations, or thrombosis throughout the 12-month evaluation period.

Results date posted

2023

Year

09

Month

25

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

2022

Year

09

Month

29

Day

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Main results already published

Date of protocol fixation

2018

Year

08

Month

10

Day

Date of IRB

2018

Year

08

Month

21

Day

Anticipated trial start date

2018

Year

10

Month

01

Day

Last follow-up date

2023

Year

11

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

09

Month

13

Day

Last modified on

2023

Year

09

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038612