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

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: NCT02733653
• Other study ID #: S6051
• Status: Completed
• Phase: N/A
• Start date: May 25, 2016
• Est. completion date: December 20, 2017

Study information

• Verified date: December 2018
• 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: 60
• Est. completion date: December 20, 2017
• Est. primary completion date: June 29, 2017
• 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 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

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	Iwaki Kyouritsu Hospital	Iwaki	Fukushima
Japan	Kasukabe Chuo General Hospital	Kasukabe	Saitama
Japan	Kishiwada Tokushukai Hospital	Kishiwada	Osaka
Japan	Kokura Memorial Hospital	Kokura	Fukuoka
Japan	Miyazaki Medical Association Hospital	Miyazaki
Japan	Nagano Red Cross Hospital	Nagano
Japan	Nagoya Kyoritsu Hospital	Nagoya	Aichi
Japan	Tokeidai Memorial Hospital	Sapporo	Hokkaido
Japan	Saiseikai Yokohama-City Eastern Hospital	Yokohama	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Procedural Success Rate	Bailout stenting or surgical procedure during the index procedure is not needed	during procedure
Other	Rate of Distal Emboli Requiring Additional Treatment		during procedure or within 24 hours post-index procedure
Other	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
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 12 months	1 month, 6 months and 12 months
Other	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
Other	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
Other	Clinically-driven TLR Rate		1 month, 6 months and 12 months
Other	Clinically-driven Target Vessel Revascularization (TVR) Rate		1 month, 6 months and 12 months
Other	Adverse Event Rates		1 month, 6 months and 12 months
Other	Distribution of Rutherford Class	Distribution of Rutherford Class as compared to baseline at 6 months and 12 months	6 months and 12 months
Other	Rate of Primary and Secondary Sustained Clinical Improvement		1 month, 6 months and 12 months
Other	Rate of Hemodynamic Improvement		1 month, 6 months and 12 months
Primary	Primary Patency Rate		6 months