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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
123
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
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
Time frame: Within 30 days after treatment
Primary Vessel Patency of the Treated Segment(s)
Assessed by computed tomography angiography (CTA) at 12 months post-procedure without Target Lesion Revascularization.
Time frame: Within 12 months after treatment
Technical Success
defined as ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30%
Time frame: within 24 hours of the index procedure
Procedural Success
defined as technical success with no Major Adverse Events (including all-cause death, clinically-driven Target Lesion Revascularization, target limb major amputation or thrombosis at target lesion)
Time frame: within 24 hours of the index procedure
Target Vessel Patency Assessed by Duplex Ultrasound Sonography
access the target vessel patency at 3 month visit by duplex ultrasound sonography
Time frame: at 3 month post index procedure
All-cause Death at 30 Days, 3, 6 and 12 Months
calculate the rate of all-cause death at 30 days, 3, 6 and 12 months after treatment
Time frame: Within 12 months after treatment
Clinically-driven Target Lesion Revascularization at 3, 6 and 12 Months
calculate the rate of Target Lesion Revascularization at 30 days, 3, 6 and 12 months after treatment
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The First Affiliated Hospital of Harbin Medicial University
Harbin, Jilin, China
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Xiangya Hospital Central South University
Changsha, China
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China
Tianjin Medical University General Hospital
Tianjin, China
Time frame: Within 12 months after treatment
Clinical Success
defined as improved Rutherford classification by at least +1 class at pre-discharge, 3 and 12 months as compared to baseline. RUTHERFORD / BECKER CLASSIFICATION Category Objective Criteria 0 Normal Treadmill /stress test 1. Completes treadmill exercise; ankle pressure (AP) after exercise \< 50 mm Hg, but \> 25 mm Hg less than BP 2. Between categories 1 and 3 3. Cannot complete treadmill exercise and AP after exercise \< 50 mm Hg 4. Resting AP \< 40 mm Hg, flat or barely pulsatile ankle or metatarsal pulse volume recording (PVR); toe pressure (TP) \< 30 mm Hg 5. Nonhealing ulcer, focal gangrene with diffuse pedal edema. Resting AP \< 60 mm Hg, ankle or metatarsal (MT) PVR flat or barely pulsatile; TP \< 40 mm Hg 6. Extending above MT level. Same as Category 5
Time frame: Within 12 months after treatment
Hemodynamic Success
defined as positive change in Ankle-Brachial Index at pre-discharge, 3 months, 12 months as compared to baseline. The ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows: * Ankle: The systolic pressure will be measured in the target limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation. * Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation.
Time frame: Within 12 months after treatment
Major Adverse Events Through 12 Months
Major Adverse Events , including all-cause death, clinically-driven Target Lesion Revascularization, target limb major amputation or thrombosis at target lesion
Time frame: Within 12 months after treatment