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

Primary Purpose

Peripheral Arterial Disease

Status

Completed

Phase

Not Applicable

Locations

Japan

Study Type

Interventional

Intervention

Jetstream Atherectomy System

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring Superficial Femoral Artery, Proximal Popliteal Artery, Endovascular therapy, Atherectomy

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Chronic, symptomatic lower limb ischemia defined as Rutherford categories 2-4
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%
Vessel diameter ≥3.0 mm and ≤6.0 mm
Total lesion length (or series of lesions) ≤150 mm

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 <80,000mm3 or >600,000mm3 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

Sites / Locations

Tokyo Bay Urayasu Ichikawa Medical Center
Kokura Memorial Hospital
Tokeidai Memorial Hospital
Kansai Rosai Hospital
Kasukabe Chuo General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Jetstream Atherectomy System

Arm Description

Outcomes

Primary Outcome Measures

Number of Patients With Lesion Success

Secondary Outcome Measures

Full Information

NCT ID

NCT03847233

First Posted

February 18, 2019

Last Updated

August 12, 2021

Sponsor

Boston Scientific Corporation

1. Study Identification

Unique Protocol Identification Number

NCT03847233

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

March 19, 2019 (Actual)

Primary Completion Date

November 8, 2019 (Actual)

Study Completion Date

May 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boston Scientific Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of the Jetstream Atherectomy System for the treatment of Japanese patients with symptomatic occlusive atherosclerotic lesions in native superficial femoral artery (SFA) and/ or proximal popliteal arteries (PPA).

Detailed Description

A prospective, multicenter, single-arm trial evaluating the safety and efficacy of the Jetstream Atherectomy System in the treatment of symptomatic occlusive atherosclerotic lesions ≤150 mm in length located in the femoropopliteal arteries in subjects with symptoms classified as Rutherford categories 2-4.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Arterial Disease

Keywords

Superficial Femoral Artery, Proximal Popliteal Artery, Endovascular therapy, Atherectomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Jetstream Atherectomy System

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Jetstream Atherectomy System

Intervention Description

A rotating, aspirating, expandable catheter system for active removal of atherosclerotic debris and thrombus in the SFA and/or PPA

Primary Outcome Measure Information:

Title

Number of Patients With Lesion Success

Time Frame

during procedure

Other Pre-specified Outcome Measures:

Title

Assisted Primary Patency

Time Frame

1 month and 6 months

Title

Primary Patency

Time Frame

1 month and 6 months

Title

Rate of Hemodynamic Improvement

Description

Rate of Hemodynamic Improvement as assessed by changes in Ankle-Brachial Index (ABI) as compared to baseline at 1 month and 6 months

Time Frame

1 month and 6 months

Title

Rate of Primary Sustained Clinical Improvement

Time Frame

1 month and 6 months

Title

Distribution of Rutherford Class

Description

Distribution of Rutherford Class at 1 month and 6 months

Time Frame

1 month and 6 months

Title

Adverse Event Rates

Time Frame

6 months

Title

Clinically-driven Target Vessel Revascularization (TVR) Rate

Time Frame

1 month and 6 months

Title

Clinically-driven TLR Rate

Time Frame

1 month and 6 months

Title

Major Adverse Event (MAE) Rate

Description

All-cause death through 1 month, and/or target limb major amputation and/or Target Lesion Revascularization (TLR) through 6 months

Time Frame

1 month and 6 months

Title

Reduction in Lesion Stenosis

Description

Change in the percent stenosis prior to treatment with Jetstream and the percent stenosis following treatment with Jetstream (Reduction in Lesion Stenosis=Pre-Jetstream percent stenosis - Post-Jetstream percent stenosis).

Time Frame

Assessed at prior to treatment with Jetstream and after treatment with Jetstream

Title

Number of Patients With Distal Emboli Requiring Additional Treatment

Time Frame

during procedure or within 24 hours post-index procedure

Title

Number of Patients With Procedural Success

Time Frame

during procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Chronic, symptomatic lower limb ischemia defined as Rutherford categories 2-4 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% Vessel diameter ≥3.0 mm and ≤6.0 mm Total lesion length (or series of lesions) ≤150 mm 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 <80,000mm3 or >600,000mm3 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kazushi Urasawa, MD, PhD

Organizational Affiliation

Tokeidai Memorial Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tokyo Bay Urayasu Ichikawa Medical Center

City

Urayasu

State/Province

Chiba

ZIP/Postal Code

279-0001

Country

Japan

Facility Name

Kokura Memorial Hospital

City

Kokura

State/Province

Fukuoka

ZIP/Postal Code

802-8555

Country

Japan

Facility Name

Tokeidai Memorial Hospital

City

Sapporo

State/Province

Hokkaido

ZIP/Postal Code

060-0031

Country

Japan

Facility Name

Kansai Rosai Hospital

City

Amagasaki

State/Province

Hyogo

ZIP/Postal Code

660-8511

Country

Japan

Facility Name

Kasukabe Chuo General Hospital

City

Kasukabe

State/Province

Saitama

ZIP/Postal Code

344-0063

Country

Japan

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

The confidentiality of records/data obtained in the trial will remain anonymous for analysis and publication. The information and data, obtained from the trial is used without personal identification.

Learn more about this trial

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

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