Clinical trial NCT02733653: Safety and Effectiveness of Jetstream Atherectomy System (J-SUPREME)
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: 2016-04-11
Enrollment: 60
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 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

Primary outcomes:
measure: Primary Patency Rate
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
measure: Procedural Success Rate
timeFrame: during procedure
measure: Rate of Distal Emboli Requiring Additional Treatment
timeFrame: during procedure or within 24 hours post-index procedure
measure: Reduction in Lesion Stenosis
timeFrame: during procedure
measure: Major Adverse Event (MAE) Rate
timeFrame: 1 month, 6 months and 12 months
measure: Primary Patency
timeFrame: 1 month, 6 months and 12 months
measure: Assisted Primary Patency
timeFrame: 1 month, 6 months and 12 months
measure: Clinically-driven TLR Rate
timeFrame: 1 month, 6 months and 12 months
measure: Clinically-driven Target Vessel Revascularization (TVR) Rate
timeFrame: 1 month, 6 months and 12 months
measure: Adverse Event Rates
timeFrame: 1 month, 6 months and 12 months
measure: Distribution of Rutherford Class
timeFrame: 6 months and 12 months
measure: Rate of Primary and Secondary Sustained Clinical Improvement
timeFrame: 1 month, 6 months and 12 months
measure: Rate of Hemodynamic Improvement
timeFrame: 1 month, 6 months and 12 months
Locations:
city: Nagoya
country: Japan
facility: Nagoya Kyoritsu Hospital
state: Aichi
city: Kokura
country: Japan
facility: Kokura Memorial Hospital
state: Fukuoka
city: Iwaki
country: Japan
facility: Iwaki Kyouritsu Hospital
state: Fukushima
city: Sapporo
country: Japan
facility: Tokeidai Memorial Hospital
state: Hokkaido
city: Amagasaki
country: Japan
facility: Kansai Rosai Hospital
state: Hyogo
city: Yokohama
country: Japan
facility: Saiseikai Yokohama-City Eastern Hospital
state: Kanagawa
city: Kishiwada
country: Japan
facility: Kishiwada Tokushukai Hospital
state: Osaka
city: Kasukabe
country: Japan
facility: Kasukabe Chuo General Hospital
state: Saitama
city: Miyazaki
country: Japan
facility: Miyazaki Medical Association Hospital
city: Nagano
country: Japan
facility: Nagano Red Cross Hospital
Study officials:
affiliation: Tokeidai Memorial Hospital
name: Kazushi Urasawa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: