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

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): 60
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

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; 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

Outcome Measure	Time Frame
Primary Patency Rate	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural Success Rate	Bailout stenting or surgical procedure during the index procedure is not needed	during procedure
Rate of Distal Emboli Requiring Additional Treatment		during procedure or within 24 hours post-index procedure
Reduction in Lesion Stenosis	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	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	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	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		1 month, 6 months and 12 months
Clinically-driven Target Vessel Revascularization (TVR) Rate		1 month, 6 months and 12 months
Adverse Event Rates		1 month, 6 months and 12 months
Distribution of Rutherford Class	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		1 month, 6 months and 12 months
Rate of Hemodynamic Improvement		1 month, 6 months and 12 months

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): May 25, 2016
• Primary Completion (Actual): June 29, 2017
• Study Completion (Actual): December 20, 2017

Study Registration Dates

• First Submitted: March 24, 2016
• First Submitted That Met QC Criteria: April 8, 2016
• First Posted (Estimate): April 11, 2016

Study Record Updates

• Last Update Posted (Actual): January 8, 2019
• Last Update Submitted That Met QC Criteria: December 17, 2018
• Last Verified: December 1, 2018

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: 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