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

NCT03847233 | Completed Results FDA Device

• 1 other identifier: S2450
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 5

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).

Conditions

Peripheral Arterial Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Lesion Success

  during procedure

Other Outcomes (12)

• Assisted Primary Patency

  1 month and 6 months

• Primary Patency

  1 month and 6 months

• Rate of Hemodynamic Improvement

  1 month and 6 months

Study Arms (1)

Jetstream Atherectomy System

EXPERIMENTAL

Device: Jetstream Atherectomy System

Interventions

Jetstream Atherectomy System DEVICE

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

Jetstream Atherectomy System

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (5)

Tokyo Bay Urayasu Ichikawa Medical Center

Urayasu, Chiba, 279-0001, Japan

Location

Kokura Memorial Hospital

Kokura, Fukuoka, 802-8555, Japan

Location

Tokeidai Memorial Hospital

Sapporo, Hokkaido, 060-0031, Japan

Location

Kansai Rosai Hospital

Amagasaki, Hyōgo, 660-8511, Japan

Location

Kasukabe Chuo General Hospital

Kasukabe, Saitama, 344-0063, Japan

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Results Point of Contact

• Title: Yoko Takizawa/Clinical Project Manager
• Organization: Boston Scientific Japan K.K.

Yoko.Takizawa@bsci.com

+81-3-6853-7500

Study Officials

• Kazushi Urasawa, MD, PhD

  Tokeidai Memorial Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2019
• First Posted: February 20, 2019
• Study Start: March 19, 2019
• Primary Completion: November 8, 2019
• Study Completion: May 20, 2020
• Last Updated: August 16, 2021
• Results First Posted: December 28, 2020

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

JP (5)