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

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

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).

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: Jetstream Atherectomy System

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.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Chiba
    • Urayasu, Chiba, Japan, 279-0001
      • Tokyo Bay Urayasu Ichikawa Medical Center
  • Fukuoka
    • Kokura, Fukuoka, Japan, 802-8555
      • Kokura Memorial Hospital
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-0031
      • Tokeidai Memorial Hospital
  • Hyogo
    • Amagasaki, Hyogo, Japan, 660-8511
      • Kansai Rosai Hospital
  • Saitama
    • Kasukabe, Saitama, Japan, 344-0063
      • Kasukabe Chuo General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Jetstream Atherectomy System	Device: Jetstream Atherectomy System; A rotating, aspirating, expandable catheter system for active removal of atherosclerotic debris and thrombus in the SFA and/or PPA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Patients With Lesion Success	during procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assisted Primary Patency		1 month and 6 months
Primary Patency		1 month and 6 months
Rate of Hemodynamic Improvement	Rate of Hemodynamic Improvement as assessed by changes in Ankle-Brachial Index (ABI) as compared to baseline at 1 month and 6 months	1 month and 6 months
Rate of Primary Sustained Clinical Improvement		1 month and 6 months
Distribution of Rutherford Class	Distribution of Rutherford Class at 1 month and 6 months	1 month and 6 months
Adverse Event Rates		6 months
Clinically-driven Target Vessel Revascularization (TVR) Rate		1 month and 6 months
Clinically-driven TLR Rate		1 month and 6 months
Major Adverse Event (MAE) Rate	All-cause death through 1 month, and/or target limb major amputation and/or Target Lesion Revascularization (TLR) through 6 months	1 month and 6 months
Reduction in Lesion Stenosis	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).	Assessed at prior to treatment with Jetstream and after treatment with Jetstream
Number of Patients With Distal Emboli Requiring Additional Treatment		during procedure or within 24 hours post-index procedure
Number of Patients With Procedural Success		during procedure

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Kazushi Urasawa, MD, PhD, Tokeidai Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2019
• Primary Completion (Actual): November 8, 2019
• Study Completion (Actual): May 20, 2020

Study Registration Dates

• First Submitted: February 18, 2019
• First Submitted That Met QC Criteria: February 18, 2019
• First Posted (Actual): February 20, 2019

Study Record Updates

• Last Update Posted (Actual): August 16, 2021
• Last Update Submitted That Met QC Criteria: August 12, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Atherectomy; Endovascular therapy; Superficial Femoral Artery; Proximal Popliteal Artery
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: S2450

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes