Prospective, Non-randomized, Multicenter Clinical Study of the Boston Scientific Paclitaxel-Coated PTA Balloon Catheter (Ranger™ and Ranger™ SL (OTW) DCB) in China
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Femoropopliteal Artery Lesions
- Sponsor
- Boston Scientific Corporation
- Enrollment
- 123
- Locations
- 9
- Primary Endpoint
- Major Adverse Events Through 30 Days Post-procedure
- Status
- Completed
- Last Updated
- 6 months ago
Overview
Brief Summary
This clinical study is a prospective, non-randomized, multicenter study to demonstrate the acceptable safety and performance of angioplasty with the Ranger DCB in native femoropopliteal artery lesions. It is intended that all patients with qualifying lesions would be considered for enrollment and treated with the Ranger DCB catheter. Approximately 123 patients with femoropopliteal artery lesions will be enrolled. All lesions will be treated with the Ranger DCB. Up to 15 clinical sites located in China are expected to participate.
Detailed Description
study objectives: The primary objective of this study is to demonstrate acceptable safety and performance of the Ranger™（Ranger \& Ranger LE） and Ranger™ SL (OTW) paclitaxel-coated PTA balloon catheter used for angioplasty of femoropopliteal artery lesions. Primary endpoints: The primary safety endpoint is the rate of following major adverse events through 30 days post-procedure: * all device and/or procedure related mortality * target limb major amputation at * Clinically-driven Target Lesion Revascularization (TLR) The primary efficacy endpoint is primary lesion patency of the treated segment(s) as assessed by computed tomography angiography (CTA) at 12 months post-procedure without clinically-driven TLR.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects must be age 18 or older
- •Subject is willing and able to provide informed consent
- •Subject is available and willing to attend all required follow-up visits
- •Subject has a clinically significant symptomatic leg ischemia
- •Subject has a Rutherford clinical category of 2 - 4
- •If the index lesion is restenotic, the prior PTA must have been \> 90 days prior to treatment in the current study
- •Only one lesion per limb can be treated under this protocol, which means that one index lesion, on one index limb will be "in treatment". However, both limbs may be treated during either the index procedure and/or subsequent procedures
- •Successful intraluminal wire crossing of the target lesion
- •Angiographic Inclusion Criteria:
- •Al1.The index lesion is a clinically and hemodynamically de novo stenotic or restenotic lesion located in the native nonstented superficial femoral artery or proximal popliteal artery between the Hunter's Canal and the popliteal fossa (i.e. within the P1 segment), with the following characteristics by visual assessment:
Exclusion Criteria
- •Subjects who have undergone prior vascular surgery of the SFA/PPA（Superficial Femoral Artery / Proximal Popliteal Artery） in the index limb to treat atherosclerotic disease
- •History of major amputation in the same limb as the target lesion
- •Presence of aneurysm in the target vessel(s)
- •Acute ischemia and/or acute thrombosis in any artery of the lower limbs
- •Acute Myocardial Infarction within 30 days before the index procedure
- •History of hemorrhagic stroke within 3 months
- •History of thrombolysis or angina within 2 weeks of enrollment
- •Persistent, intraluminal thrombus of the proposed target lesion post thrombolytic therapy
- •Known hypersensitivity or contraindication to contrast dye that, in the opinion of the investigator, cannot be adequately pre-medicated
- •Known allergies against Paclitaxel or other components of the used medical devices
Outcomes
Primary Outcomes
Major Adverse Events Through 30 Days Post-procedure
Time Frame: Within 30 days after treatment
* all device and/or procedure related mortality * target limb major amputation at * Clinically-driven Target Lesion Revascularization
Primary Vessel Patency of the Treated Segment(s)
Time Frame: Within 12 months after treatment
Assessed by computed tomography angiography (CTA) at 12 months post-procedure without Target Lesion Revascularization.
Secondary Outcomes
- Technical Success(within 24 hours of the index procedure)
- Clinical Success(Within 12 months after treatment)
- Hemodynamic Success(Within 12 months after treatment)
- Target Vessel Patency Assessed by Duplex Ultrasound Sonography(at 3 month post index procedure)
- Clinically-driven Target Lesion Revascularization at 3, 6 and 12 Months(Within 12 months after treatment)
- All-cause Death at 30 Days, 3, 6 and 12 Months(Within 12 months after treatment)
- Procedural Success(within 24 hours of the index procedure)
- Major Adverse Events Through 12 Months(Within 12 months after treatment)