{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,2]],"date-time":"2026-06-02T12:12:25Z","timestamp":1780402345186,"version":"3.54.1"},"reference-count":30,"publisher":"MDPI AG","issue":"11","license":[{"start":{"date-parts":[[2026,5,29]],"date-time":"2026-05-29T00:00:00Z","timestamp":1780012800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>Background: Femoral arteriotomy closure after peripheral angiography and intervention is commonly achieved using vascular closure devices (VCDs) or compression-based strategies; however, comparative randomised data in contemporary peripheral endovascular practice remain limited. Methods: In this prospective randomised trial, adults undergoing femoral-access diagnostic angiography or peripheral endovascular intervention were assigned in a 1:1 ratio to haemostasis with the FemoStop\u2122 II Gold pneumatic compression system or a contemporary VCD strategy. The primary endpoint was a composite of major or minor groin-site complications immediately after sheath removal. Secondary endpoints included composite complications at recovery, discharge, and 30 days, with separate analyses of major and minor complications. Patient-reported pain was assessed using the Verbal Numerical Rating Scale (VNRS). Efficacy and safety analyses were performed according to the intention-to-treat and as-treated principles, respectively. Risk ratios were estimated using modified Poisson regression with robust variance, with prespecified adjustment for sex, systolic blood pressure before sheath removal, and sheath size. Results: A total of 130 participants underwent randomisation, including 66 assigned to FemoStop\u2122 II Gold and 64 assigned to VCDs. The primary composite endpoint occurred in 23\/66 participants (34.9%) in the FemoStop\u2122 II Gold group and 16\/64 (25.0%) in the VCD group (absolute difference, 9.9 percentage points; 95% confidence interval [CI], \u22126.1 to 25.7; p = 0.25), with the numerical difference driven predominantly by minor-only events (28.8% versus 15.6%; p = 0.09). At 30 days, the composite endpoint occurred in 17\/66 participants (25.8%) and 12\/64 participants (18.8%), respectively (absolute difference, 7.0 percentage points; 95% CI, \u221213.3 to 26.4; p = 0.40). Serious access-site events remained infrequent both immediately post-procedure (6.1% versus 9.4%; p = 0.53) and at 30 days (6.1% versus 4.7%; p = 0.72). The adjusted risk ratios were 1.28 (95% CI, 0.74 to 2.21) for the primary composite endpoint and 1.23 (95% CI, 0.63 to 2.40) for the 30-day composite endpoint. Ordinal VNRS pain distributions did not differ significantly at any timepoint, although \u201cany pain\u201d immediately post-procedure was less frequent with FemoStop\u2122 II Gold (22.7% versus 40.6%; unadjusted risk ratio, 0.56; 95% CI, 0.33 to 0.93); this association was attenuated after adjustment (adjusted risk ratio, 0.63; 95% CI, 0.38 to 1.03). Prespecified interaction testing suggested that the effect of treatment on composite complications varied according to sheath size both immediately post-procedure and at 30 days (p &lt; 0.001 for both interactions). Conclusions: In patients undergoing femoral-access diagnostic angiography or peripheral endovascular intervention, haemostasis with FemoStop\u2122 II Gold resulted in 30-day groin-site complication rates that did not differ significantly from those observed with contemporary VCD strategies. Serious access-site events remained infrequent in both groups, and the apparent early reduction in patient-reported pain with FemoStop\u2122 II Gold was not definitive after adjustment. Larger, adequately powered multicentre studies are warranted to clarify sheath size-dependent effects and uncommon clinically consequential vascular events.<\/jats:p>","DOI":"10.3390\/jcm15114197","type":"journal-article","created":{"date-parts":[[2026,5,29]],"date-time":"2026-05-29T17:36:18Z","timestamp":1780076178000},"page":"4197","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Mechanical Compression Versus Vascular Closure Devices for Femoral Artery Haemostasis After Peripheral Endovascular Procedures: A Randomised Controlled Trial"],"prefix":"10.3390","volume":"15","author":[{"given":"Irina","family":"Shevchenko","sequence":"first","affiliation":[{"name":"Cabrini Hospital, 183 Wattletree Road, Malvern, VIC 3144, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bernardette Jingfei","family":"Lee","sequence":"additional","affiliation":[{"name":"Department of Vascular and Endovascular Surgery, Sir Charles Gairdner Hospital, Perth, WA 6009, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1962-8212","authenticated-orcid":false,"given":"Davina","family":"Daudu","sequence":"additional","affiliation":[{"name":"Department of Vascular and Endovascular Surgery, Royal Perth Hospital, Perth, WA 6000, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5922-1436","authenticated-orcid":false,"given":"James","family":"Dodd","sequence":"additional","affiliation":[{"name":"Department of Vascular and Endovascular Surgery, Sir Charles Gairdner Hospital, Perth, WA 6009, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jackie","family":"Wong","sequence":"additional","affiliation":[{"name":"Department of Vascular and Endovascular Surgery, Royal Perth Hospital, Perth, WA 6000, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olufemi Ayoadeleke","family":"Oshin","sequence":"additional","affiliation":[{"name":"Department of Vascular and Endovascular Surgery, Royal Perth Hospital, Perth, WA 6000, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fernando","family":"Picazo-Pineda","sequence":"additional","affiliation":[{"name":"Department of Vascular and Endovascular Surgery, Royal Perth Hospital, Perth, WA 6000, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mahmoud","family":"Al-Najjar","sequence":"additional","affiliation":[{"name":"Australian Vascular, Perth, WA 6000, Australia"},{"name":"Rural Clinical School of Western Australia, University of Western Australia, Perth, WA 6009, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tanya Michelle","family":"Rhine","sequence":"additional","affiliation":[{"name":"Department of Vascular and Endovascular Surgery, Sir Charles Gairdner Hospital, Perth, WA 6009, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carolina","family":"Bravo Ceballos","sequence":"additional","affiliation":[{"name":"Department of Vascular and Endovascular Surgery, Sir Charles Gairdner Hospital, Perth, WA 6009, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1977-0382","authenticated-orcid":false,"given":"Bibombe Patrice","family":"Mwipatayi","sequence":"additional","affiliation":[{"name":"School of Surgery, RPH Research Foundation Building 56, Murray Street, Perth, WA 6000, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,5,29]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"1329","DOI":"10.1016\/S0140-6736(13)61249-0","article-title":"Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: A systematic review and analysis","volume":"382","author":"Fowkes","year":"2013","journal-title":"Lancet"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"156","DOI":"10.1038\/nrcardio.2016.179","article-title":"Peripheral artery disease: Epidemiology and global perspectives","volume":"14","author":"Fowkes","year":"2017","journal-title":"Nat. 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