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

Peripheral Arterial Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03847233
• Other study ID #: S2450
• Status: Completed
• Phase: N/A
• Start date: March 19, 2019
• Est. completion date: May 20, 2020

Study information

• Verified date: August 2021
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: May 20, 2020
• Est. primary completion date: November 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

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

Locations

Country	Name	City	State
Japan	Kansai Rosai Hospital	Amagasaki	Hyogo
Japan	Kasukabe Chuo General Hospital	Kasukabe	Saitama
Japan	Kokura Memorial Hospital	Kokura	Fukuoka
Japan	Tokeidai Memorial Hospital	Sapporo	Hokkaido
Japan	Tokyo Bay Urayasu Ichikawa Medical Center	Urayasu	Chiba

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assisted Primary Patency		1 month and 6 months
Other	Primary Patency		1 month and 6 months
Other	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
Other	Rate of Primary Sustained Clinical Improvement		1 month and 6 months
Other	Distribution of Rutherford Class	Distribution of Rutherford Class at 1 month and 6 months	1 month and 6 months
Other	Adverse Event Rates		6 months
Other	Clinically-driven Target Vessel Revascularization (TVR) Rate		1 month and 6 months
Other	Clinically-driven TLR Rate		1 month and 6 months
Other	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
Other	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
Other	Number of Patients With Distal Emboli Requiring Additional Treatment		during procedure or within 24 hours post-index procedure
Other	Number of Patients With Procedural Success		during procedure
Primary	Number of Patients With Lesion Success		during procedure