Trials / Completed
CompletedNCT02944071
Ranger™ and Ranger™ SL (OTW) DCB) in China
Prospective, Non-randomized, Multicenter Clinical Study of the Boston Scientific Paclitaxel-Coated PTA Balloon Catheter (Ranger™ and Ranger™ SL (OTW) DCB) in China
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 123 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Boston Scientific Ranger™ and Ranger™ SL Paclitaxel-Coated PTA Balloon Catheter |
Timeline
- Start date
- 2016-11-24
- Primary completion
- 2020-12-22
- Completion
- 2020-12-22
- First posted
- 2016-10-25
- Last updated
- 2025-10-27
- Results posted
- 2022-03-10
Locations
9 sites across 1 country: China
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02944071. Inclusion in this directory is not an endorsement.