Evidence mapPaperPMID 40696475Full record

ArticleEuropean journal of medical research2025

S.M.A.R.T. Flex vascular stent system in femoropopliteal arteries: 18-month result of a real-world registry.

Meng Ye, XiangJiang Guo, Qihong Ni, Zhenyu Shi, Lianrui Guo, Xixiang Gao, Zibo Feng, Zhu Tong, Xiang Wang

Abstract read
In one paragraph

Article in European journal of medical research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Meng Ye *Department of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.
XiangJiang Guo *Department of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.
Qihong NiDepartment of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.
Zhenyu ShiDepartment of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.
Lianrui GuoDepartment of Vascular Surgery, Xuanwu Hospital Capital Medical University, Beijing, China.
Xixiang GaoDepartment of Vascular Surgery, Xuanwu Hospital Capital Medical University, Beijing, China.
Zibo FengDepartment of Vascular Surgery, Liyuan Hospital Affiliated Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.
Zhu Tong *Department of Vascular Surgery, Xuanwu Hospital Capital Medical University, Beijing, China. vasculartongzhu@163.com.
Xiang Wang *Department of Vascular Surgery, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai, 200120, China. rad_wangxiang@hotmail.com.

Funding

Cultivation fund of Renji Hospital YPYJJ210257
6 · The paper itself

Abstract

objectiveTo evaluate the efficacy and safety of the S.M.A.R.T. Flex stents for treating femoropopliteal (FP) occlusive lesions, including complex Trans-Atlantic Inter-Society Consensus (TASC) II C/D and severely calcified lesions.

methodsThis retrospective study utilized the TALENT registry database (a prospective study), enrolling patients who underwent S.M.A.R.T. Flex implantation from January 2021 to July 2022. The primary effectiveness endpoint was the rate of freedom from clinically driven target lesion revascularization (CD-TLR) at 18 months, and the primary safety endpoint was the 18-month rate of freedom from major adverse events (all-cause death, above-the-ankle target limb amputation, or CD-TLR).

resultsA total of 122 patients with 124 limbs were included, with an average follow-up of 617 days. The average lesion length was 24.9 ± 20.4 cm, and 73.8 and 54.1% of the lesions had chronic total occlusions and chronic limb-threatening ischemia, respectively. A total of 127 stents were placed in 107 limbs, with 1 stent placed in 88 limbs (82.2%), 2 stents placed in 18 limbs (16.8%), and 3 stents implanted in 1 limb (0.9%). In this study, 50.5% of the limbs were treated with DCBs, and 83.3% of the TASC C/D lesions were treated primarily with DCBs. The 12- month rate of primary patency was 73.1%. The 18-month rate of freedom from CD-TLR was 93.9% (95% CI: 89.2-98.8%), and the major adverse event-free rate was 75.7% (95% CI: 68.0-84.3%). A total of 92.5% of patients showed primary sustained clinical improvement, and the Vascular Quality of Life Questionnaire scores were significantly improved at 18 months compared with baseline.

conclusionsThe S.M.A.R.T. Flex stents demonstrate promising efficacy and safety as a treatment option for long-segment complex femoropopliteal artery lesions.

Indexed as

Endovascular ProceduresFemoral ArteryPeripheral Arterial DiseasePopliteal ArteryStentsAgedAged, 80 and overFemaleHumansMaleMiddle AgedProspective StudiesRegistriesRetrospective StudiesTreatment OutcomeChronic limb-threatening ischemiaClinically driven target lesion revascularizationFemoropoplitealPeripheral artery diseaseS.M.A.R.T. Flex

Identifiers

PMID40696475
PMCPMC12281990

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.