Prospective, Non-randomized, Multicenter Clinical Study of the JETSTREAM™ Atherectomy System (Jetstream) in Treatment of Occlusive Atherosclerotic Lesions in the Superficial Femoral and/or Proximal Popliteal Arteries in Chinese Patients
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Atherosclerosis
- Sponsor
- Boston Scientific Corporation
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- The Primary Effectiveness Endpoint-Acute Reduction of Percent Diameter Stenosis
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This clinical study is a prospective, non-randomized, multicenter, single-arm study to demonstrate the acceptable safety and performance of the JETSTREAM™ Atherectomy System (Jetstream) used during percutaneous peripheral vascular intervention in patients with occlusive atherosclerotic lesions in the native SFA and/or PPA. It is intended that all patients with qualifying lesions would be considered for enrollment and treated with the Jetstream System.
Detailed Description
study objectives: To evaluate the safety and effectiveness of JETSTREAM™ Atherectomy System (Jetstream) for treating symptomatic Chinese patients with occlusive atherosclerotic lesions in native superficial femoral artery (SFA) and/ or proximal popliteal arteries (PPA)during percutaneous peripheral vascular intervention. Planed Indications for use: The Jetstream System is intended for use in atherectomy of the peripheral vasculature and to break apart and remove atherosclerotic disease, debris, and thrombus from the SFA and/or PPA. Primary Safety Endpoint: Major Adverse Event (MAE), defined as all-cause death, target limb unplanned major amputation and/or target lesion revascularization (TLR), within 30 days post index procedure Primary Effectiveness Endpoint: Acute reduction of percent diameter stenosis (%DS) post atherectomy but prior to any adjunctive therapy, when compared to its baseline diameter stenosis (absolute mean percentage).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects age 18 and older
- •Subject or the subject's legal representative is willing and able to provide consent before any study-specific test or procedure is performed, signs the consent form, and agrees to attend all required follow-up visits
- •Subject has documented chronic, symptomatic lower limb ischemia defined as Rutherford categories 2 - 4, and is eligible for percutaneous peripheral vascular intervention
- •Stenotic, restenotic or occlusive lesion(s) located in the native SFA and/or PPA, and meet all of following angiographic criteria by visual assessment:
- •i. Atherosclerotic lesion with diameter stenosis ≥70% ii. Guidewire must cross lesion(s) within the true lumen, without a sub-intimal course by physicians performed, based on visual estimate iii. Minimum vessel diameter proximal to the lesion ≥ 3 mm and \< and =6 mm iv. Lesion length of single or multiple focal stenosis or chronic total occlusion (CTO) lesion can be up to 15 cm long v. Target lesion located at least 3 cm above the inferior edge of the femur
- •Patent infrapopliteal and popliteal artery, i.e., single distal runoff or better with at least one of three vessels patent (\< 50% stenosis by visual assessment) to the ankle or foot with no planned intervention
Exclusion Criteria
- •Target lesion is located in the iliac artery or above the SFA
- •Target lesion stenosis \< 70%
- •Target lesion is moderately to severely angulated (\> 30°) or torturous at treatment segment
- •Target lesion/vessel previously treated with drug-coated balloon within 12 months prior to the index procedure
- •Target lesion/vessel previously treated with atherectomy, laser or other debulking devices prior to the index procedure
- •Target lesion/vessel with in-stent restenosis
- •Subjects who have undergone prior surgery or endovascular intervention of SFA/PPA in the target limb to treat atherosclerotic disease within 3 month prior to the index procedure
- •Use of drug-coated devices, or laser or any other debulking devices other than Jetstream System (such as CTO devices or cutting balloon) in the target limb during the index procedure
- •History of major amputation in the target limb
- •Documented life expectancy less than 12 months due to other medical co-morbid condition(s)
Outcomes
Primary Outcomes
The Primary Effectiveness Endpoint-Acute Reduction of Percent Diameter Stenosis
Time Frame: Index Procedure (Core-lab will analysis the procedural angiograms to assess the acute reduction of percent diameter stenosis (%DS))
Acute reduction of percent diameter stenosis (%DS) post atherectomy but prior to any adjunctive therapy, when compared to its baseline diameter stenosis (absolute mean percentage).
The Primary Safety Endpoint-The Rate of Major Adverse Event (MAE) at 30 Days Follow up
Time Frame: 30days
defined as all-cause death, target limb unplanned major amputation and/or target lesion revascularization (TLR), within 30 days post index procedure.