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New treatment option for Peripheral Arterial Disease
Official title A Trail of Sperstent® Used for Residual Lesions of Femoropopliteal Arteries
ClinicalTrials.gov ID: NCT06539689
What this study is testing
- What it's testing
- This is a prospective, multi-center, randomized trial designed to investigate the efficacy and safety of Sperstent® peripheral spot stent system versus Everflex® self-expanding peripheral stent system in the endovascular treatment of post-balloon angioplasty (post-PTA) residual lesions including stenoses and/or dissections in femoral and proximal popliteal arteries.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Age 18-85 years old, male or female;
- The target lesion is located in the superficial femoral artery or the proximal popliteal artery;
- Peripheral arterial stenosis or occlusive disease with symptoms consistent with the Rutherford classification 2 to 5;
- Estimated life expectancy \>1 year;
- Subject has been informed of and understands the nature of the study and provides signed informed consent to participate in the study. Angiographic
You likely can't join if
- Target vessel had undergone open surgery such as bypass surgery or the target lesion is in-stent restenosis;
- Patients with serum creatinine \>2.5mg/dl during screening or undergoing long-term hemodialysis or peritoneal dialysis;
- Severe coagulation disorder;
- Patients with major vascular-related diseases, including acute lower extremity ischemia, active disseminated intravascular coagulation...
- A history of major organ failure or other serious illness (including severe coronary heart disease, severe cardiac insufficiency, severe neurosis, or...
- Myocardial infarction or symptomatic stroke occurred within 3 months prior to enrollment;
See the full eligibility criteria
Who can join
- Age 18-85 years old, male or female;
- The target lesion is located in the superficial femoral artery or the proximal popliteal artery;
- Peripheral arterial stenosis or occlusive disease with symptoms consistent with the Rutherford classification 2 to 5;
- Estimated life expectancy \>1 year;
- Subject has been informed of and understands the nature of the study and provides signed informed consent to participate in the study. Angiographic
- Stenosis rate ≥70% under DSA by visual estimate, or 100% occluded lesion with a total lesion length less than 150mm (by visual estimate);
- Reference vessel diameter is between 3 mm and 7.5 mm, 50mm≤Total cumulative length of target lesions≤250mm; (In the case of bilimb lesions, a single target lesion with one limb meeting the protocol criteria is selected...
- After PTA treatment by DCB, there exists residual lesions, such as the target lesion has over 30% residual DS and/or presence of at least one post-PTA dissection (Type A-F) (by visual estimate);
- Patients with unobstructed inflow tract or successfully treated, visual residual stenosis ≤50%;
- Angiography showed at least one outflow tract was unobstructed at the distal end (Stenosis degree ≤70% before intervention).
What rules you out
- Target vessel had undergone open surgery such as bypass surgery or the target lesion is in-stent restenosis;
- Patients with serum creatinine \>2.5mg/dl during screening or undergoing long-term hemodialysis or peritoneal dialysis;
- Severe coagulation disorder;
- Patients with major vascular-related diseases, including acute lower extremity ischemia, active disseminated intravascular coagulation, thromboangiitis obliterans, deep vein thrombosis, and aneurysms of therapeutic...
- A history of major organ failure or other serious illness (including severe coronary heart disease, severe cardiac insufficiency, severe neurosis, or mental illness); Have received or plan organ transplantation, severe...
- Myocardial infarction or symptomatic stroke occurred within 3 months prior to enrollment;
- Thrombolysis of target vessel within 72 hours before surgery, did not completely dissolve the thrombus;
- Systemic infection or uncontrolled infection within the target limb;
- Known allergy to contrast agents, nickel or titanium (Nitinol), heparin, aspirin, clopidogrel, anesthetics;
- Women who are pregnant or breast-feeding, or women of childbearing age who have family plans within 1 year;
- Patients who are planning to have major lower limb amputations on the target side of the lesion;
- Endovascular or surgical procedures are performed on the target limb within 30 days before or 30 days after surgery;
- Participating in clinical trials of other medical devices or drugs;
- The investigator considers the patient is not suitable for participation in the clinical trial. Angiographic Exclusion Criteria:
- Failure of the guidewire to pass through the lesion；
- During the procedure, the target lesions had received or were scheduled to receive volume reduction procedures such as cryogenic angioplasty, laser angioplasty, and percutaneous intracavity plaque gyrotomy；
- The target lesion before stent implantation is thrombotic obliteration, which is not suitable for stent implantation；
- The target lesions were severely calcified and could not fully predilate; Or grade 4 calcification；
- Acute vascular occlusion or acute or subacute thrombosis in the target lesion；
- Stent was implanted into the target vessel before enrollment.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Shijiazhuang, Hebei, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Nanjing, Jiangsu, China
- Nantong, Jiangsu, China
- Shanghai, Shanghai Municipality, China
- Luzhou, Sichuan, China
- Hangzhou, Zhejiang, China
- Chengdu, China
- Shanghai, 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 to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Shijiazhuang, Hebei, China; Zhengzhou, Henan, China; Wuhan, Hubei, China; Nanjing, Jiangsu, China and 6 more location(s). 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.