Dissection, Peripheral Arterial Disease, Stenosis
Conditions
Keywords
Peripheral Arterial Disease, Spot stent
Brief summary
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.
Interventions
DEVICESperstent® peripheral spot stent system
Sperstent® peripheral spot stent system, Percutaneous Transluminal Angioplasty (PTA), Digital Subtraction Angiography（DSA）
DEVICEEverflex® self-expanding peripheral stent system
Everflex® self-expanding peripheral stent system, Percutaneous Transluminal Angioplasty (PTA), Digital Subtraction Angiography（DSA）
Sponsors
FrontAce Scientific Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Patency | 12 months post-operation | Primary patency defined as freedom from clinically driven target lesion revascularization (CD-TLR) and freedom from duplex ultrasound derived binary restenosis at 12 months post-operation.(defined as PSVR \>2.5) |
| Freedom from Major Adverse Events (MAEs) | 30 days post-operation | Freedom from the occurrence of any new-onset MAEs defined as all-cause death, index limb amputation (above the ankle), or clinically-driven target lesion revascularization (CD-TLR) at 30 days post-operation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Primary Patency at 30 days and 6 months | 30 days and 6 months post-operation | defined as freedom from clinically driven target lesion revascularization (CD-TLR) and freedom from duplex ultrasound derived binary restenosis at 30 days and 6 months post-operation (defined as PSVR \>2.5) |
| Rate of clinically driven target lesion revascularization (CD-TLR) | 30 days, 6 months and 12 months post-operation | Clinically driven target lesion revascularization (CD-TLR) was defined as an endovascular reintervention performed for a \>50% diameter stenosis of the target vessel in the presence of a recurrent PAD symptom after the initial endovascular procedure. |
| Changes from Baseline in Rutherford Classification | 30 days, 6 months and 12 months post-operation | Defined as change in target limb Rutherford class from baseline. Rutherford Classification is defined as follows, with increasing severity: Rutherford Category 0 - Asymptomatic. Rutherford Category 1 - Mild Claudication. Rutherford Category 2 - Moderate Claudication. Rutherford Category 3 - Severe Claudication. Rutherford Category 4 - Ischemic Rest Pain. Rutherford Category 5 - Minor Tissue Loss (minor exertion). Rutherford Category 6 - Major Tissue Loss (gangrene). |
| Rate of Device Success | immediately post-operation | Defined as successful delivery, release and retrieval of the device. |
| Duplex Ultrasound (DUS) Derived Lesion Patency | 30 days, 6 months and 12 months post-operation | Lesion Patency is evaluated by Duplex Ultrasound (DUS) |
| Rate of major adverse event(s) (MAEs) | 6 months and 12 months post-operation | MAEs defined as all-cause death, index limb amputation (above the ankle), or clinically-driven target lesion revascularization (CD-TLR) . |
| Rate of Stent Fracture | 12 months post-operation | Stent fractures will be analyzed by X-ray at 12 months post-operation. The stents implanted into a certain subject will be analyzed collectively in the assessment. Stent fractures will be assessed with Grade I, II, III or IV as follow. Grade I - a single strut fracture only. Grade II - multiple single strut fractures that occur at different sites of a stent or different stents. Grade III - multiple nitinol stent fractures resulting in complete transverse linear fracture. Grade IV - a spiral dissection of a stent. Fractures of Grade I are least severe, increasing in severity to Grade IV. |
| Changes from Baseline in Ankle-brachial Index (ABI) | 30 days, 6 months and 12 months post-operation | Defined as change of target limb ABI from baseline. The Ankle Brachial Index (ABI) is the systolic pressure at the ankle, divided by the systolic pressure at the arm. |
| Rate of Procedural Success | immediately post-operation | Demonstrated vessel patency (\<30% residual DS, by visual estimate) without the use of a bailout stent or the occurrence of MAE upon completion of the index procedure. |
Countries
China
Contacts
Primary ContactMin Zhou, Dr.
Backup ContactXiang Wang, Dr.
Outcome results
None listed