Back to resultsSmart Flex Stent System for the Treatment Long Femoropopliteal Artery Lesions
Primary Purpose
Peripheral Arterial Disease
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Smart flex stent
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring Femoropopliteal lesions, Patency
Eligibility Criteria
Inclusion Criteria: The patient presented a score from 2 to 5 following Rutherford classification The patient is willing to comply with specified follow-up evaluations at the specified times The patient is >18 years old Patient understands the nature of the procedure and provides written informed consent before enrolment in the study The patient has a projected life expectancy of at least 24 months Before enrolment, the guidewire has crossed the target lesion Target lesion length ≧150mm by angiographic estimation Stenosis > 50% or occlusion in the femoropopliteal artery There is angiographic evidence of patent distal popliteal artery and at least one distal runoff to the foot Exclusion Criteria: Previous bypass surgery or stenting in the target vessel Patients who exhibit acute intraluminal thrombus at the target lesion vessel Patients with known hypersensitivity or contraindication to any of the following medications: Nitinol-titanium, antiplatelet therapy, anticoagulants, or thrombolytics therapy Pregnant women or Female patients with potential childbearing Use of thrombectomy, atherectomy, or laser devices during the procedure Untreated inflow disease of the ipsilateral pelvic arteries (more than 50% stenosis or occlusion The patient is currently participating in another investigational drug or device study that has not reached the primary endpoint. Significant renal dysfunction (Serum creatinine >2.0mg/dl) Patient with Known allergy to contrast media
Sites / Locations
- Renji HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Smart flex stent group
Arm Description
Smart flex stent will be used for patients with femoropopliteal lesions receiving endovascular treatment.
Outcomes
Primary Outcome Measures
Primary patency
Primary patency is freedom from clinically directed target lesion revascularization (CD-TLR) and from Duplex ultrasound-derived binary restenosis (defined as peak systolic velocity ratio ≧2.5).
Freedom of major adverse events (MAEs)
Major adverse events(MAEs) is defined as index limb amputation above the ankle, clinically directed target lesion revascularization(CD-TLR), or all-cause death.
Secondary Outcome Measures
Acute procedure success
Acute procedure success is defined as technique success ( the achievement of final residual diameter stenosis <30% for stent and <50% for angioplasty or atherectomy by angiography at the end of the procedure and without flow-limiting arterial dissection or hemodynamically significant trans-lesional pressure gradient <10 mm Hg for endovascular revascularization ) and freedom form major adverse events.
Primary patency
Primary patency is freedom from clinically directed target lesion revascularization (CD-TLR) and from Duplex ultrasound-derived binary restenosis (defined as peak systolic velocity ratio ≧2.5).
Freedom from clinically directed target lesion revascularization
Patients without clinically directed target lesion revascularization
Freedom of major adverse events (MAEs)
Major adverse events(MAEs) is defined as index limb amputation above the ankle, clinically directed target lesion revascularization(CD-TLR), or all-cause death.
Primary sustained clinical improvement
Primary sustained clinical improvement is defined as an upward shift on the Rutherford classification to a level of claudication without the need for repeated TLR in surviving patients without the need for unplanned amputation.
Vasc quality of life score
Change of Vasc quality of life
Full Information
NCT ID
NCT05894863
First Posted
May 31, 2023
Last Updated
May 31, 2023
Sponsor
RenJi Hospital
Collaborators
Xuanwu Hospital, Beijing, Second Affiliated Hospital of Soochow University, First Affiliated Hospital of Zhejiang University, First People's Hospital of Hangzhou, Qingdao Haici Hospital, Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology, Fudan University, Dongfang Hospital Beijing University of Chinese Medicine, Xiamen Cardiovascular Hospital, Xiamen University
1. Study Identification
Unique Protocol Identification Number
NCT05894863
Brief Title
Smart Flex Stent System for the Treatment Long Femoropopliteal Artery Lesions
Official Title
Smart Flex Stent System for the Treatment Long Femoropopliteal Artery Lesions: the SAFARI Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2023 (Actual)
Primary Completion Date
January 2, 2026 (Anticipated)
Study Completion Date
January 2, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RenJi Hospital
Collaborators
Xuanwu Hospital, Beijing, Second Affiliated Hospital of Soochow University, First Affiliated Hospital of Zhejiang University, First People's Hospital of Hangzhou, Qingdao Haici Hospital, Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology, Fudan University, Dongfang Hospital Beijing University of Chinese Medicine, Xiamen Cardiovascular Hospital, Xiamen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study aims to evaluate the effectiveness and safety of the Smart flex stent system in treating long femoropopliteal native lesions.
Detailed Description
One hundred twenty patients with lesion lengths longer than 15 cm will be included. Patients will be invited for a follow-up visit at 1, 6, 12, and 24-month post-procedure. The primary effectiveness endpoint of the study is the primary patency at 12 months. The primary safety endpoint is freedom of major adverse events (MAEs) at 12 months. Secondary endpoints include acute procedure success rate; primary patency rate at 1, 6, and 24 months; freedom from TLR at 1-, 6-, 12, and 24-month follow-up; primary and secondary sustained clinical improvements at 1-, 6-, 12- and 24-month follow-up; Freedom of MAEs at 1-, 6-,12- and 24- month follow-up; change of quality of life at 1-, 6-,12- and 24- month follow-up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
Keywords
Femoropopliteal lesions, Patency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Smart flex stent group
Arm Type
Experimental
Arm Description
Smart flex stent will be used for patients with femoropopliteal lesions receiving endovascular treatment.
Intervention Type
Device
Intervention Name(s)
Smart flex stent
Intervention Description
Smart flex stent will be used for femoropopliteal occlusive lesions.
Primary Outcome Measure Information:
Title
Primary patency
Description
Primary patency is freedom from clinically directed target lesion revascularization (CD-TLR) and from Duplex ultrasound-derived binary restenosis (defined as peak systolic velocity ratio ≧2.5).
Time Frame
12-month
Title
Freedom of major adverse events (MAEs)
Description
Major adverse events(MAEs) is defined as index limb amputation above the ankle, clinically directed target lesion revascularization(CD-TLR), or all-cause death.
Time Frame
12-month
Secondary Outcome Measure Information:
Title
Acute procedure success
Description
Acute procedure success is defined as technique success ( the achievement of final residual diameter stenosis <30% for stent and <50% for angioplasty or atherectomy by angiography at the end of the procedure and without flow-limiting arterial dissection or hemodynamically significant trans-lesional pressure gradient <10 mm Hg for endovascular revascularization ) and freedom form major adverse events.
Time Frame
72-hour within procedure
Title
Primary patency
Description
Primary patency is freedom from clinically directed target lesion revascularization (CD-TLR) and from Duplex ultrasound-derived binary restenosis (defined as peak systolic velocity ratio ≧2.5).
Time Frame
24-month
Title
Freedom from clinically directed target lesion revascularization
Description
Patients without clinically directed target lesion revascularization
Time Frame
24-month
Title
Freedom of major adverse events (MAEs)
Description
Major adverse events(MAEs) is defined as index limb amputation above the ankle, clinically directed target lesion revascularization(CD-TLR), or all-cause death.
Time Frame
24-month
Title
Primary sustained clinical improvement
Description
Primary sustained clinical improvement is defined as an upward shift on the Rutherford classification to a level of claudication without the need for repeated TLR in surviving patients without the need for unplanned amputation.
Time Frame
24-month
Title
Vasc quality of life score
Description
Change of Vasc quality of life
Time Frame
24-month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patient presented a score from 2 to 5 following Rutherford classification
The patient is willing to comply with specified follow-up evaluations at the specified times
The patient is >18 years old
Patient understands the nature of the procedure and provides written informed consent before enrolment in the study
The patient has a projected life expectancy of at least 24 months
Before enrolment, the guidewire has crossed the target lesion
Target lesion length ≧150mm by angiographic estimation
Stenosis > 50% or occlusion in the femoropopliteal artery
There is angiographic evidence of patent distal popliteal artery and at least one distal runoff to the foot
Exclusion Criteria:
Previous bypass surgery or stenting in the target vessel
Patients who exhibit acute intraluminal thrombus at the target lesion vessel
Patients with known hypersensitivity or contraindication to any of the following medications: Nitinol-titanium, antiplatelet therapy, anticoagulants, or thrombolytics therapy
Pregnant women or Female patients with potential childbearing
Use of thrombectomy, atherectomy, or laser devices during the procedure
Untreated inflow disease of the ipsilateral pelvic arteries (more than 50% stenosis or occlusion
The patient is currently participating in another investigational drug or device study that has not reached the primary endpoint.
Significant renal dysfunction (Serum creatinine >2.0mg/dl)
Patient with Known allergy to contrast media
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ni Qihong, M.D.
Phone
+8615801900772
Email
niqihong1989@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meng Ye, M.D.
Organizational Affiliation
Department of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Renji Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ni Qihong, M.D.
Phone
+86 15801900772
Email
niqihong1989@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Smart Flex Stent System for the Treatment Long Femoropopliteal Artery Lesions
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