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New treatment option for Peripheral Arterial Disease
Official title Smart Flex Stent System for the Treatment Long Femoropopliteal Artery Lesions
ClinicalTrials.gov ID: NCT05894863
What this study is testing
- What it's testing
- This study aims to evaluate the effectiveness and safety of the Smart flex stent system in treating long femoropopliteal native lesions.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The patient presented a score from 2 to 5 following Rutherford classification
- The patient is willing to comply with specified follow-up evaluations at the specified times
- The patient is \>18 years old
- Patient understands the nature of the procedure and provides written informed consent before enrolment in the study
- The patient has a projected life expectancy of at least 24 months
You likely can't join if
- Previous bypass surgery or stenting in the target vessel
- Patients who exhibit acute intraluminal thrombus at the target lesion vessel
- Patients with known hypersensitivity or contraindication to any of the following medications: Nitinol-titanium, antiplatelet therapy, anticoagulants...
- Pregnant women or Female patients with potential childbearing
- Use of thrombectomy, atherectomy, or laser devices during the procedure
- Untreated inflow disease of the ipsilateral pelvic arteries (more than 50% stenosis or occlusion
See the full eligibility criteria
- The patient presented a score from 2 to 5 following Rutherford classification
- The patient is willing to comply with specified follow-up evaluations at the specified times
- The patient is \>18 years old
- Patient understands the nature of the procedure and provides written informed consent before enrolment in the study
- The patient has a projected life expectancy of at least 24 months
- Before enrolment, the guidewire has crossed the target lesion
- Target lesion length ≧150mm by angiographic estimation
- Stenosis \> 50% or occlusion in the femoropopliteal artery
- There is angiographic evidence of patent distal popliteal artery and at least one distal runoff to the foot
- Previous bypass surgery or stenting in the target vessel
- Patients who exhibit acute intraluminal thrombus at the target lesion vessel
- Patients with known hypersensitivity or contraindication to any of the following medications: Nitinol-titanium, antiplatelet therapy, anticoagulants, or thrombolytics therapy
- Pregnant women or Female patients with potential childbearing
- Use of thrombectomy, atherectomy, or laser devices during the procedure
- Untreated inflow disease of the ipsilateral pelvic arteries (more than 50% stenosis or occlusion
- The patient is currently participating in another investigational drug or device study that has not reached the primary endpoint.
- Significant renal dysfunction (Serum creatinine \>2.0mg/dl)
- Patient with Known allergy to contrast media
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.