{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T23:49:34Z","timestamp":1792799374366,"version":"4.5.0"},"reference-count":18,"publisher":"SAGE Publications","issue":"1","license":[{"start":{"date-parts":[[2024,7,24]],"date-time":"2024-07-24T00:00:00Z","timestamp":1721779200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"DOI":"10.13039\/100032681","name":"Meril Life Sciences Pvt. Ltd.","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100032681","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["J Endovasc Ther"],"published-print":{"date-parts":[[2026,2]]},"abstract":"<jats:sec>\n                    <jats:title>Purpose:<\/jats:title>\n                    <jats:p>This trial was designed and aimed to compare safety and efficacy of Obtura\u2122 vascular closure device (VCD) to manual compression (MC) among patients undergoing transfemoral catheterization.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Material and Methods:<\/jats:title>\n                    <jats:p>This prospective, randomized, controlled, multicenter trial of Obtura VCD against MC randomized patients in 1:1 (n=268; 134:134) ratio. Safety and efficacy were measured by primary endpoints (time to hemostasis [TTH] and deployment success) and secondary endpoints which included technical success, device-related adverse events, and time to ambulation (TTA).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>The procedural access using right femoral artery was performed in 95.52% of patients in Obtura VCD versus 96.27% in standard MC method, whereas 2.99% of patients in each group underwent left femoral access. Bilateral access was performed in 1.49% (n=2) versus 0.75% (n=1) in Obtura VCD versus MC, respectively. Both the technical success and deployment success were 100%. Patients in Obtura VCD group had shorter TTH (3.26\u00b13.39 vs 23.95\u00b18.24 minutes; p&lt;0.0001) and TTA (155.44\u00b1125.32 vs 723.84\u00b1197.98 minutes; p&lt;0.0001) than MC group. No access site complications (re-bleeding, infection, arteriovenous fistula, and transient access site nerve injury) were noted at 2-week, 1-month, and 3-month follow-ups. There were 4 (3%) and 6 (4.5%) cases of hematoma, respectively, in Obtura VCD versus MC and 1 case (0.7%) of post-procedural arterial pseudoaneurysm each in both the groups which were successfully resolved and patients were discharged with no further complications. Further follow-up was without any adverse events.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>The study demonstrated favorable safety and efficacy of Obtura\u2122 VCD with a significantly short TTH and TTA compared to MC.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical Impact<\/jats:title>\n                    <jats:p>In patients undergoing cardiac catheterization, vascular closure devices (VCDs) can achieve hemostasis faster after successful implantation of the device with fewer complications such as bleeding and ambulation can be achieved faster. In terms of effectiveness, Obtura VCD was found to be better than manual compression in achieving early hemostasis and higher technical and deployment success was accomplished. Obtura VCD does not require enlargement of the route through the tissues, uses the same existing arterial sheath as its conduit, and does not cause patients\u2019 access sites to feel uncomfortable while it is being deployed.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/15266028241258662","type":"journal-article","created":{"date-parts":[[2024,7,24]],"date-time":"2024-07-24T03:18:15Z","timestamp":1721791095000},"page":"414-423","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":4,"title":["Comparing Obtura Vascular Closure Device to Manual Compression for Achieving Hemostasis After Percutaneous Transfemoral Procedures: A Randomized Study"],"prefix":"10.1177","volume":"33","author":[{"given":"Tom","family":"Devasia","sequence":"first","affiliation":[{"name":"Department of Cardiology, Kasturba Medical College Manipal Academy of Higher Education, Manipal, Karnataka, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rajendra Kumar","family":"Premchand","sequence":"additional","affiliation":[{"name":"Krishna Institute of Medical Sciences (KIMS), Secunderabad, Telangana, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Santosh K.","family":"Sinha","sequence":"additional","affiliation":[{"name":"LPS Institute of Cardiology and Cardiac Surgery, Kanpur, Uttar Pradesh, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Atul","family":"Rewatkar","sequence":"additional","affiliation":[{"name":"Pulse Clinic and Hospital, Nagpur, Maharashtra, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keyur","family":"Parikh","sequence":"additional","affiliation":[{"name":"Care Institute of Medical Sciences (CIMS) Hospital, Ahmedabad, Gujarat, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jaspal","family":"Arneja","sequence":"additional","affiliation":[{"name":"Arneja Heart and Multispeciality Hospital, Nagpur, Maharashtra, India"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2024,7,24]]},"reference":[{"key":"e_1_3_2_2_2","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.28703"},{"key":"e_1_3_2_3_2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2014.15305"},{"key":"e_1_3_2_4_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.avsg.2018.02.016"},{"key":"e_1_3_2_5_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCINTERVENTIONS.117.006074"},{"key":"e_1_3_2_6_2","doi-asserted-by":"publisher","DOI":"10.1177\/1129729819854593"},{"key":"e_1_3_2_7_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.carrev.2017.08.009"},{"issue":"19","key":"e_1_3_2_8_2","first-page":"847","article-title":"[Manual compression versus mechanical compression device (FemoStop) after diagnostic coronary angiography with\/without intervention]","volume":"114","author":"Stiebellehner L","year":"2002","unstructured":"Stiebellehner L, Nikfardjan M, Diem K, et al [Manual compression versus mechanical compression device (FemoStop) after diagnostic coronary angiography with\/without intervention]. Wien Klin Wochenschr. 2002;114(19\u201320):847\u2013852.","journal-title":"Wien Klin Wochenschr"},{"key":"e_1_3_2_9_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.avsg.2019.06.031"},{"key":"e_1_3_2_10_2","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.26991"},{"key":"e_1_3_2_11_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCINTERVENTIONS.114.001306"},{"key":"e_1_3_2_12_2","doi-asserted-by":"publisher","DOI":"10.4244\/EIJV10I2A31"},{"key":"e_1_3_2_13_2","doi-asserted-by":"publisher","DOI":"10.4244\/EIJV10I2A32"},{"key":"e_1_3_2_14_2","doi-asserted-by":"publisher","DOI":"10.7150\/ijms.14476"},{"key":"e_1_3_2_15_2","doi-asserted-by":"publisher","DOI":"10.1067\/mhj.2002.121464"},{"key":"e_1_3_2_16_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ihj.2016.06.008"},{"key":"e_1_3_2_17_2","doi-asserted-by":"publisher","DOI":"10.1007\/s12928-016-0409-x"},{"key":"e_1_3_2_18_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jscai.2022.100370"},{"key":"e_1_3_2_19_2","doi-asserted-by":"publisher","DOI":"10.1186\/s12872-022-02512-0"}],"container-title":["Journal of Endovascular Therapy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/15266028241258662","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/15266028241258662","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/15266028241258662","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,29]],"date-time":"2026-04-29T21:30:47Z","timestamp":1777498247000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/15266028241258662"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,7,24]]},"references-count":18,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2026,2]]}},"alternative-id":["10.1177\/15266028241258662"],"URL":"https:\/\/doi.org\/10.1177\/15266028241258662","relation":{},"ISSN":["1526-6028","1545-1550"],"issn-type":[{"value":"1526-6028","type":"print"},{"value":"1545-1550","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,7,24]]}}}