Stents Post-dilation With DCB or POBA in Femoropopliteal Arteries
NCT03791970 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180
Last updated 2026-05-01
Summary
To compare the efficacy and safety of stent angioplasty with Orchid 035 Drug Coated Dilatation (DCB) and Plain Old Balloon Angioplasty (POBA) for post-dilatation for long (\>10cm) femoropopliteal chronic total occlusion.
Conditions
Interventions
- DEVICE
-
Orchid 035 DCB Catheter
Stents placement for femoropopliteal arterial occlusions following with Orchid 035 DCB Catheter for post-dilation
- DEVICE
-
POBA Catheter
Stents placement for femoropopliteal arterial occlusions following with POBA for post-dilation
Sponsors & Collaborators
-
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
lead OTHER
Principal Investigators
-
Xinwu Lu, MD, PhD · Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-01-01
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
Countries
- China
Study Locations
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