Actively Recruiting
Stents Post-dilation With DCB or POBA in Femoropopliteal Arteries
Led by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Updated on 2026-05-01
180
Participants Needed
3
Research Sites
417 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Stents Post-dilation With DCB or POBA in Femoropopliteal Arteries
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Leg condition classified as Rutherford Category 2 to 4
- Have a new or non-stented restenotic lesion with a long-term blockage of 10 cm or more suitable for stent placement
- Able to be treated with drug-coated balloon or plain balloon angioplasty after stent placement
- Target vessel diameter between 4.0 and 7.0 mm suitable for available devices
- At least one open native artery to the ankle free from significant narrowing (50% stenosis or less)
- No prior vascular interventions within 2 weeks before and no planned interventions within 30 days after the study treatment, except specific femoral patch angioplasty
- Female participants of childbearing potential must have a negative pregnancy test within 7 days before the procedure
- Lesion located at least 1 cm below the common femoral bifurcation and in the P1 segment of the popliteal artery
You will not qualify if you...
- Pregnant, breastfeeding, planning pregnancy, or men planning to father children
- Contraindications to stent, drug-coated balloon, or plain balloon angioplasty
- Life expectancy less than 1 year
- Unable to take required blood-thinning medications or allergic to contrast media, nickel, titanium, or tantalum that cannot be managed
- Planned treatment of outflow disease during the procedure
- Use of laser, atherectomy, or cryoplasty during the procedure
- Sudden symptom onset, acute vessel blockage, or recent blood clots in the target vessel
- History of stroke within 3 months
- History of heart attack, thrombolysis, or angina within 2 weeks before enrollment
- Participation in another investigational drug or device study until this study's primary endpoint is reached or prior enrollment in this study
- Any other medical condition that may cause noncompliance or affect data interpretation
- Target vessel or lesion involving a previously placed stent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Kaichuang Ye
Shanghai, Shanghai Municipality, China, 200011
Actively Recruiting
2
Minyi Yin
Shanghai, Shanghai Municipality, China, 200011
Actively Recruiting
3
Xiaobing Liu
Shanghai, Shanghai Municipality, China, 200011
Actively Recruiting
Research Team
K
Kai'chuang Ye, MD, PhD
CONTACT
X
Xinrui Yang, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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