A Trail of Sperstent® Used for Residual Lesions of Femoropopliteal Arteries

NCT06539689 | Recruiting DMC

• 1 other identifier: FA001
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 12

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.

Conditions

Peripheral Arterial Disease; Stenosis; Dissection

Keywords

Peripheral Arterial Disease; Spot stent

Outcome Measures

Primary Outcomes (2)

• Primary Patency

  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)

  12 months post-operation

• Freedom from Major Adverse Events (MAEs)

  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.

  30 days post-operation

Secondary Outcomes (9)

• Rate of Device Success

  immediately post-operation

• Rate of Procedural Success

  immediately post-operation

• Primary Patency at 30 days and 6 months

  30 days and 6 months post-operation

• Rate of clinically driven target lesion revascularization (CD-TLR)

  30 days, 6 months and 12 months post-operation

• Changes from Baseline in Rutherford Classification

  30 days, 6 months and 12 months post-operation

Study Arms (2)

Sperstent® peripheral spot stent system

EXPERIMENTAL

subjects using the Sperstent® peripheral spot stent system

Device: Sperstent® peripheral spot stent system

Everflex® self-expanding peripheral stent system

ACTIVE COMPARATOR

subjects using the Everflex® self-expanding peripheral stent system

Device: Everflex® self-expanding peripheral stent system

Interventions

Sperstent® peripheral spot stent system DEVICE

Sperstent® peripheral spot stent system, Percutaneous Transluminal Angioplasty (PTA), Digital Subtraction Angiography（DSA）

Sperstent® peripheral spot stent system

Everflex® self-expanding peripheral stent system DEVICE

Everflex® self-expanding peripheral stent system, Percutaneous Transluminal Angioplasty (PTA), Digital Subtraction Angiography（DSA）

Everflex® self-expanding peripheral stent system

Eligibility Criteria

• Age: 18 Years - 85 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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.
• 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).

You may not qualify 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, 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.
• Failure of the guidewire to pass through the lesion；

Sponsors & Collaborators

• FrontAce Scientific Co., Ltd: lead

Study Sites (12)

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

MeSH Terms

Conditions

Peripheral Arterial Disease; Constriction, Pathologic

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Min Zhou, Dr.

CONTACT

01186-25-83106666; zhouminnju@126.com

Xiang Wang, Dr.

CONTACT

01186-21-38804518; vascular_doc@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 6, 2024
• Study Start: June 4, 2024
• Primary Completion (Estimated): December 4, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 6, 2024

Record last verified: 2024-07

Locations

CN (12)