Using Sperstent® for treating residual lesions in leg arteries

A Prospective, Multicenter and Randomized Controlled Trial to Evaluate the Efficacy and Safety of Sperstent® Peripheral Spot Stent System Used for the Residual Lesions After Percutaneous Transluminal Angioplasty of Femoropopliteal Arteries

This study is testing whether the Sperstent® can help people with leftover blockages in their leg arteries feel better compared to another type of stent called Everflex®.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: FrontAce Scientific Co., Ltd (Industry-sponsored)
• Locations: 12 sites (Beijing, Beijing Municipality and 11 other locations)
• Trial ID: NCT06539689 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of the Sperstent® peripheral spot stent system compared to the Everflex® self-expanding peripheral stent system. It focuses on patients with residual lesions in the femoral and proximal popliteal arteries following balloon angioplasty. The study is prospective and multi-center, involving randomization to ensure unbiased results. Participants will be monitored for improvements in their condition and any potential complications.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-85 with significant stenosis or occlusive disease in the superficial femoral or proximal popliteal arteries.

Not a fit: Patients with lesions not meeting the specified criteria or those with a life expectancy of less than one year may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients with peripheral arterial disease.

How similar studies have performed: Previous studies have shown promise in using similar stent systems for treating peripheral arterial disease, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* 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 Inclusion Criteria:

* 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 by the investigator; More than 2cm between lesions are considered as 2 lesions);
* 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).

Exclusion Criteria:

* 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 lateral vessels (deep femur, superficial femur, or popliteal artery);
* 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 gastrointestinal bleeding);
* 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.

Where this trial is running

Beijing, Beijing Municipality and 11 other locations

• Beijing Friendship Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (Not_yet_recruiting)
• The Second Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (Not_yet_recruiting)
• First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Not_yet_recruiting)
• Liyuan Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
• Nanjing Drum Tower Hospital — Nanjing, Jiangsu, China (Recruiting)
• Affiliated Hospital of Nantong University — Nantong, Jiangsu, China (Not_yet_recruiting)
• Renji Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
• The Affiliated Hospital of Southwest Medical University — Luzhou, Sichuan, China (Not_yet_recruiting)
• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Not_yet_recruiting)
• Hospital of Chengdu University of TCM — Chengdu, China (Not_yet_recruiting)
• Shanghai East Hospital — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Min Zhou, Dr.

Conditions Peripheral Arterial Disease; Stenosis; Dissection; Spot stent