UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036056
Receipt number R000041049
Scientific Title A Prospective, Multicenter, Single-arm Clinical Trial of Jetstream Atherectomy System for the Treatment of Japanese Patients with Symptomatic Occlusive Atherosclerotic Lesions in the Superficial Femoral and/ or Proximal Popliteal Arteries
Date of disclosure of the study information 2019/03/01
Last modified on 2020/06/22 15:04:40

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Basic information

Public title

A Prospective, Multicenter, Single-arm Clinical Trial of Jetstream Atherectomy System for the Treatment of Japanese Patients with Symptomatic Occlusive Atherosclerotic Lesions in the Superficial Femoral and/ or Proximal Popliteal Arteries

Acronym

Safety and Effectiveness of Jetstream Atherectomy System (J-SUPREME II)

Scientific Title

A Prospective, Multicenter, Single-arm Clinical Trial of Jetstream Atherectomy System for the Treatment of Japanese Patients with Symptomatic Occlusive Atherosclerotic Lesions in the Superficial Femoral and/ or Proximal Popliteal Arteries

Scientific Title:Acronym

Safety and Effectiveness of Jetstream Atherectomy System (J-SUPREME II)

Region

Japan


Condition

Condition

Peripheral Arterial Disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety and effectiveness of the Jetstream Atherectomy System (BSJ009J) for the treatment of Japanese patients with symptomatic occlusive atherosclerotic lesions in native SFA and/ or PPA

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III


Assessment

Primary outcomes

Lesion success rate at the index procedure

Key secondary outcomes

- Procedural success rate
- Rate of distal emboli requiring additional treatment during the procedure or within 24 hours post-index procedure.
- Reduction in lesion stenosis, that is, the difference between the percent stenosis prior to treatment with Jetstream and the percent stenosis following treatment with Jetstream
- MAE rate at 1 month and 6 months
- Clinically-driven TLR and Target Vessel Revascularization (TVR) Rate at each time point
- Adverse Event rates at each time point
- Distribution of Rutherford Class as compared to baseline at 1 month and 6 months post-index procedure
- Rate of Primary and Secondary Sustained Clinical Improvement
- Rate of Hemodynamic Improvement as assessed by changes in Ankle-Brachial Index as compared to baseline at 1 month and 6 months post-index procedure
- Primary Patency and Assisted Primary Patency at 1 month and 6 months


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Jetstream Atherectomy System

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

- Chronic, symptomatic lower limb ischemia defined as Rutherford categories 2, 3 or 4.
- Stenotic, restenotic or occlusive lesion(s) located in the native SFA and/or PPA of which meet the following criteria:
- Severely calcified lesions with degree of stenosis =>70% by visual angiographic assessment
- Vessel diameter =>3.0 mm and <=6.0 mm by visual estimate
- Total lesion length (or series of lesions) <=150 mm by visual estimate

Key exclusion criteria

- Target lesion/vessel with in-stent restenosis
- History of major amputation in the target limb
- Subject has a history of coagulopathy or hypercoagulable bleeding disorder
- Subject with untreatable hemorrhagic disease or platelet count <80,000 mm^3 or >600,000 mm^3 as baseline assessment.
- History of myocardial infarction, or stroke/cerebrovascular accident (CVA) within 6 months prior to study enrollment
- Unstable angina pectoris at the time of the enrollment
- Septicemia at the time of enrollment
- Presence of other hemodynamically significant outflow lesions in the target limb requiring a planned surgical intervention or endovascular procedure within 30 days after the index procedure
- Presence of aneurysm in the target vessel
- Acute ischemia and/or acute thrombosis of the SFA/PPA prior to the index procedure
- Perforated vessel as evidenced by extravasation of contrast media prior to the index procedure

Target sample size

31


Research contact person

Name of lead principal investigator

1st name Kazushi
Middle name
Last name URASAWA

Organization

Tokeidai Memorial Hospital

Division name

Cardiovascular Center

Zip code

060-0031

Address

2-3, North-1, East-1, Chuo-Ku Sapporo, Hokkaido, Japan

TEL

011-251-1221

Email

k-urasawa@tokeidaihosp.or.jp


Public contact

Name of contact person

1st name Yoko
Middle name
Last name TAKIZAWA

Organization

Boston Scientific Japan K.K.

Division name

Clinical Sciences

Zip code

164-0001

Address

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

TEL

03-6853-7500

Homepage URL


Email

Yoko.Takizawa@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

Kokura Memorial Hospital IRB

Address

3-2-1 Asano, Kokura kita-ku, Kitakyushu-city, Fukuoka

Tel

093-511-3248

Email

crc@kokurakinen.or.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

NCT03847233

Org. issuing International ID_1

ClinicalTrials.gov

Study ID_2


Org. issuing International ID_2


IND to MHLW

初回届出年月日: 2016年2月8日; 届出回数: 第2回


Institutions

Institutions

時計台記念病院(北海道)、春日部中央総合病院(埼玉県)、関西労災病院(兵庫県)、小倉記念病院(福岡県)、東京ベイ浦安市川医療センター(千葉県)


Other administrative information

Date of disclosure of the study information

2019 Year 03 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

31

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

2019 Year 02 Month 05 Day

Date of IRB

2019 Year 02 Month 18 Day

Anticipated trial start date

2019 Year 03 Month 19 Day

Last follow-up date

2020 Year 05 Month 20 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 03 Month 01 Day

Last modified on

2020 Year 06 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041049


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name