Trial reportCardiovascular and interventional radiology2021
A Randomized Trial Comparing Polymer Versus Suture-Based Vascular Closure Devices for Arterial Closure Following Lower-Limb Arterial Endovascular Revascularization.
Trial report in Cardiovascular and interventional radiology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03192033 (STEP), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled 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.
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.
STEP: Proglide® Versus Femoseal®: A Randomized Controlled Trial to Compare the Efficacy of Arterial Closure Devices Following Endovascular Peripheral Arterial Procedures
Who cites it
5 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.
- ESR Essentials: arterial vascular access and closure devices-practice recommendations by the Cardiovascular and Interventional Radiological Society of Europe.European radiology · 2025Guideline
- FEMOSEAL CLOSE: multi-centre observational study with FemoSeal™ vascular closure device following peripheral percutaneous endovascular procedures.CVIR endovascular · 2025Article
- Adverse Events in Open Surgical vs. Ultrasound-Guided Percutaneous Brachial Access for Endovascular Interventions.Journal of clinical medicine · 2024Article
- Closure Device Migration: An Unusual Cause of Acute Limb Ischaemia Following a Simple Endovascular Procedure.EJVES vascular forum · 2024Article
- Effectiveness and Safety of Different Vascular Closure Devices: Multicentre Prospective Observational study.Cardiovascular and interventional radiology · 2023Observational
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 8 institutions in 1 country.
Funding
Abstract
purposesThe primary objective of this study (STEP trial) was to compare the efficacy of the polymer-based FemoSeal® vascular closure device (VCD) and the suture-based ProGlide® VCD in achieving hemostasis at the femoral access site after lower-limb arterial endovascular revascularization. MATERIALS AND
methodsSTEP was a multicenter randomized clinical trial including patients undergoing lower-limb arterial endovascular revascularization. The primary endpoint was technical success 5 h after the VCD intervention, defined as achievement of hemostasis without the need for a follow-up intervention at the access site and without a 2-g/dL drop in hemoglobin.
resultsBetween December 2017 and April 2019, 113 patients were assigned to the FemoSeal® group (FS) and 117 to the ProGlide® group (PG). VCD interventions were technically successful for 90 FS patients (80%) and 58 PG patients (50%) (odds ratio, 3.98; 95% CI, 2.22 to 7.14; p < 0.0001). This difference in success rates between FS and PG is partly explained by more frequent recourse to manual compression (FS: n = 19; PG: n = 45) and an additional VCD (FS: n = 0; PG: n = 23) in the latter group. After 5 h, 87% of FS patients and 69% of PG patients resumed ambulation (odds ratio: 3.07; 95% CI: 1.93 to 6.15; p = 0.0016).
conclusionsIn patients undergoing lower-limb arterial endovascular revascularization, FemoSeal® was superior to ProGlide® in terms of technical success. CLINICAL
trial registrationStep trial was registered on http://ClinicalTrials.gov (NCT03192033).
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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 OpenQuestion graph.