Peripheral Arterial DiseaseNCT05894863
Smart Flex Stent System for the Treatment Long Femoropopliteal Artery Lesions
A study testing Smart flex stent in people with Peripheral Arterial Disease, run by RenJi Hospital at 1 site in China.
Trial summary
This study aims to evaluate the effectiveness and safety of the Smart flex stent system in treating long femoropopliteal native lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Smart flex stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 31 May 2023to 2 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Renji Hospital
Shanghai, Shanghai Municipality, 200127
Ni Qihong, M.D., +86 15801900772, niqihong1989@163.com
About this study
Official title: Smart Flex Stent System for the Treatment Long Femoropopliteal Artery Lesions: the SAFARI Study
This study aims to evaluate the effectiveness and safety of the Smart flex stent system in treating long femoropopliteal native lesions.
Read the 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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Smart flex stent
- Keywords
- Femoropopliteal lesions, Patency
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart flex stentDevice
Smart flex stent will be used for femoropopliteal occlusive lesions.
| Study group | Role | What they receive |
|---|---|---|
| Smart flex stent group | Experimental | Smart flex stent will be used for patients with femoropopliteal lesions receiving endovascular treatment. Receives: Device: Smart flex stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12-month
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.
Measured: 12-month
Secondary outcomes (6)
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.
Measured: 72-hour within procedure
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).
Measured: 24-month
Freedom from clinically directed target lesion revascularization
Patients without clinically directed target lesion revascularization
Measured: 24-month
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.
Measured: 24-month
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.
Measured: 24-month
Vasc quality of life score
Change of Vasc quality of life
Measured: 24-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start31 May 2023
- Primary completion2 Jan 2026 (estimated)
- Study completion2 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Meng Ye, M.D., Principal investigator, Department of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05894863
- Sponsor's protocol ID
- The SAFARI Study
- Status last verified
- May 2023
- First submitted
- 31 May 2023
- Last updated
- 8 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart Flex Stent System for the Treatment Long Femoropopliteal Artery Lesions: the SAFARI Study
- ClinicalTrials.gov ID
- NCT05894863
- Acronym / sponsor ID
- The SAFARI Study
- Conditions
- Peripheral Arterial Disease
- Keywords
- Femoropopliteal lesions, Patency
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- 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
- Study start
- 31 May 2023 (actual)
- Primary completion
- 2 Jan 2026 (estimated)
- Study completion
- 2 Jan 2027 (estimated)
- First posted
- 8 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Smart flex stent group | Experimental | Device: Smart flex stentSmart flex stent will be used for patients with femoropopliteal lesions receiving endovascular treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smart flex stentSmart flex stent will be used for femoropopliteal occlusive lesions. | Device | Smart flex stent group |
Primary outcome
Primary patency
Time frame: 12-month
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)
Time frame: 12-month
Major adverse events(MAEs) is defined as index limb amputation above the ankle, clinically directed target lesion revascularization(CD-TLR), or all-cause death.
6 secondary outcomes
Acute procedure success
Time frame: 72-hour within procedure
Primary patency
Time frame: 24-month
Freedom from clinically directed target lesion revascularization
Time frame: 24-month
Freedom of major adverse events (MAEs)
Time frame: 24-month
Primary sustained clinical improvement
Time frame: 24-month
Vasc quality of life score
Time frame: 24-month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Meng Ye, M.D. principal investigator
Department of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smart flex stent in people with Peripheral Arterial Disease, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ni Qihong, M.D. (+8615801900772, niqihong1989@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary patency (time frame: 12-month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2023.