Clinical trial NCT03847233: Safety and Effectiveness of Jetstream Atherectomy System (J-SUPREME II)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: Superficial Femoral Artery
Proximal Popliteal Artery
Endovascular therapy
Atherectomy
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2019-02-20
Enrollment: 31
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Patients With Lesion Success
timeFrame: during procedure
Secondary outcomes:
Other outcomes:
measure: Assisted Primary Patency
timeFrame: 1 month and 6 months
measure: Primary Patency
timeFrame: 1 month and 6 months
measure: Rate of Hemodynamic Improvement
timeFrame: 1 month and 6 months
measure: Rate of Primary Sustained Clinical Improvement
timeFrame: 1 month and 6 months
measure: Distribution of Rutherford Class
timeFrame: 1 month and 6 months
measure: Adverse Event Rates
timeFrame: 6 months
measure: Clinically-driven Target Vessel Revascularization (TVR) Rate
timeFrame: 1 month and 6 months
measure: Clinically-driven TLR Rate
timeFrame: 1 month and 6 months
measure: Major Adverse Event (MAE) Rate
timeFrame: 1 month and 6 months
measure: Reduction in Lesion Stenosis
timeFrame: Assessed at prior to treatment with Jetstream and after treatment with Jetstream
measure: Number of Patients With Distal Emboli Requiring Additional Treatment
timeFrame: during procedure or within 24 hours post-index procedure
measure: Number of Patients With Procedural Success
timeFrame: during procedure
Locations:
city: Urayasu
country: Japan
facility: Tokyo Bay Urayasu Ichikawa Medical Center
state: Chiba
city: Kokura
country: Japan
facility: Kokura Memorial Hospital
state: Fukuoka
city: Sapporo
country: Japan
facility: Tokeidai Memorial Hospital
state: Hokkaido
city: Amagasaki
country: Japan
facility: Kansai Rosai Hospital
state: Hyogo
city: Kasukabe
country: Japan
facility: Kasukabe Chuo General Hospital
state: Saitama
Study officials:
affiliation: Tokeidai Memorial Hospital
name: Kazushi Urasawa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: