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

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
China
Beijing Friendship Hospital, Capital Medical University
NOT_YET_RECRUITING
Beijing
Hospital of Chengdu University of TCM
NOT_YET_RECRUITING
Chengdu
The First Affiliated Hospital of Chongqing Medical University
NOT_YET_RECRUITING
Chongqing
The First Affiliated Hospital, Zhejiang University School of Medicine
NOT_YET_RECRUITING
Hangzhou
The Affiliated Hospital of Southwest Medical University
NOT_YET_RECRUITING
Luzhou
Nanjing Drum Tower Hospital
RECRUITING
Nanjing
Affiliated Hospital of Nantong University
NOT_YET_RECRUITING
Nantong
Renji Hospital, Shanghai Jiao Tong University School of Medicine
NOT_YET_RECRUITING
Shanghai
Shanghai East Hospital
RECRUITING
Shanghai
The Second Hospital of Hebei Medical University
NOT_YET_RECRUITING
Shijiazhuang
Liyuan Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
First Affiliated Hospital of Zhengzhou University
NOT_YET_RECRUITING
Zhengzhou
Contact Information
Primary
Min Zhou, Dr.
zhouminnju@126.com
01186-25-83106666
Backup
Xiang Wang, Dr.
vascular_doc@qq.com
01186-21-38804518
Time Frame
Start Date: 2024-06-04
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 240
Treatments
Experimental: Sperstent® peripheral spot stent system
subjects using the Sperstent® peripheral spot stent system
Active_comparator: Everflex® self-expanding peripheral stent system
subjects using the Everflex® self-expanding peripheral stent system
Sponsors
Leads: FrontAce Scientific Co., Ltd

This content was sourced from clinicaltrials.gov