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

December 17, 2018 updated by: Boston Scientific Corporation

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Miyazaki, Japan, 880-0834
        • Miyazaki Medical Association Hospital
      • Nagano, Japan, 380-8582
        • Nagano Red Cross Hospital
    • Aichi
      • Nagoya, Aichi, Japan, 454-0933
        • Nagoya Kyoritsu Hospital
    • Fukuoka
      • Kokura, Fukuoka, Japan, 802-8555
        • Kokura Memorial Hospital
    • Fukushima
      • Iwaki, Fukushima, Japan, 973-8555
        • Iwaki Kyouritsu Hospital
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-0031
        • Tokeidai Memorial Hospital
    • Hyogo
      • Amagasaki, Hyogo, Japan, 660-8511
        • Kansai Rosai Hospital
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 230-8765
        • Saiseikai Yokohama-City Eastern Hospital
    • Osaka
      • Kishiwada, Osaka, Japan, 596-8522
        • Kishiwada Tokushukai Hospital
    • Saitama
      • Kasukabe, Saitama, Japan, 344-0063
        • Kasukabe Chuo General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 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 all of the following criteria:

    • Calcified lesions with degree of stenosis ≥70% or occlusions
    • Guidewire must cross lesion(s) within the true lumen, without a sub-intimal course
    • Vessel diameter ≥3.0 mm and ≤6.0 mm
    • Total lesion length (or series of lesions) ≤150mm
    • Target lesion located at least 3 cm above the inferior edge of the femur by visual estimate
  • Patent infrapopliteal and popliteal artery

Exclusion Criteria:

  • Target lesion/vessel with in-stent restenosis
  • Target lesion/vessel previously treated with drug-coated balloon <12 months prior to the procedure
  • Target lesion/vessel previously treated with any stent placement, atherectomy, laser or other debulking devices prior to the procedure
  • Subjects who have undergone surgery or endovascular of the SFA/PPA in the target vessel to treat atherosclerotic disease within 3 months prior to the index procedure
  • Use of drug-coated devices, atherectomy, laser or other debulking devices other than the Jetstream System, chronic total occlusion (CTO) devices or cutting balloon, Angioscore or similar devices in the target limb SFA/PPA during the index procedure
  • 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.
  • Concomitant renal failure with a serum creatinine >2.0 mg/dL
  • Receiving dialysis or immunosuppressant therapy
  • 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Jetstream Atherectomy System
Adjunctive therapy with Jetstream Atherectomy System for percutaneous intervention
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Primary Patency Rate
Time Frame: 6 months
6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Procedural Success Rate
Time Frame: during procedure
Bailout stenting or surgical procedure during the index procedure is not needed
during procedure
Rate of Distal Emboli Requiring Additional Treatment
Time Frame: during procedure or within 24 hours post-index procedure
during procedure or within 24 hours post-index procedure
Reduction in Lesion Stenosis
Time Frame: during procedure
The difference between the percent stenosis prior to treatment with Jetstream and the percent stenosis following treatment with Jetstream.
during procedure
Major Adverse Event (MAE) Rate
Time Frame: 1 month, 6 months and 12 months
All-cause death through 1 month, and/or target limb major amputation and/or Target Lesion Revascularization (TLR) through 12 months
1 month, 6 months and 12 months
Primary Patency
Time Frame: 1 month, 6 months and 12 months
Percentage (%) of lesions that reach endpoint without a hemodynamically significant stenosis on Duplex Ultrasound (DUS) and without Target Lesion Revascularization (TLR) or, bypass of the target lesion.
1 month, 6 months and 12 months
Assisted Primary Patency
Time Frame: 1 month, 6 months and 12 months
Percentage (%) of lesions without TLR and those with TLR (not due to complete occlusion or by-pass) that reach endpoint without restenosis.
1 month, 6 months and 12 months
Clinically-driven TLR Rate
Time Frame: 1 month, 6 months and 12 months
1 month, 6 months and 12 months
Clinically-driven Target Vessel Revascularization (TVR) Rate
Time Frame: 1 month, 6 months and 12 months
1 month, 6 months and 12 months
Adverse Event Rates
Time Frame: 1 month, 6 months and 12 months
1 month, 6 months and 12 months
Distribution of Rutherford Class
Time Frame: 6 months and 12 months
Distribution of Rutherford Class as compared to baseline at 6 months and 12 months
6 months and 12 months
Rate of Primary and Secondary Sustained Clinical Improvement
Time Frame: 1 month, 6 months and 12 months
1 month, 6 months and 12 months
Rate of Hemodynamic Improvement
Time Frame: 1 month, 6 months and 12 months
1 month, 6 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Scientific Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kazushi Urasawa, MD, PhD, Tokeidai Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 25, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 29, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 11, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 8, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • S6051

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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