MARC details
| 000 -LEADER |
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| fixed length control field |
05326nam a22006857a 4500 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
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| fixed length control field |
190724s20192019 xxu||||| |||| 00| 0 eng d |
| 022 ## - INTERNATIONAL STANDARD SERIAL NUMBER |
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| International Standard Serial Number |
1941-7640 |
| 024 ## - OTHER STANDARD IDENTIFIER |
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| Standard number or code |
10.1161/CIRCINTERVENTIONS.119.007258 [doi] |
| 040 ## - CATALOGING SOURCE |
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| Original cataloging agency |
Ovid MEDLINE(R) |
| 099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC) |
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| PMID |
31296082 |
| 245 ## - TITLE STATEMENT |
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| Title |
Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the MANTA Percutaneous Vascular Closure Device. |
| 251 ## - Source |
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| Source |
Circulation: Cardiovascular Interventions. 12(7):e007258, 2019 07. |
| 252 ## - Abbreviated Source |
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| Abbreviated source |
Circ., Cardiovasc. interv.. 12(7):e007258, 2019 07. |
| 252 ## - Abbreviated Source |
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| Former abbreviated source |
Circ., Cardiovasc. interv.. 12(7):e007258, 2019 Jul. |
| 253 ## - Journal Name |
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| Journal name |
Circulation. Cardiovascular interventions |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Year |
2019 |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Manufacturer |
FY2020 |
| 265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE] |
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| Publication status |
ppublish |
| 266 ## - Date added to catalog |
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| Date added to catalog |
2019-07-24 |
| 268 ## - Previous citation |
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| -- |
Circulation: Cardiovascular Interventions. 12(7):e007258, 2019 Jul. |
| 501 ## - WITH NOTE |
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| Local holdings |
Available online from MWHC library: 2008 - present |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
BACKGROUND: Open surgical closure and small-bore suture-based preclosure devices have limitations when used for transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, or percutaneous thoracic endovascular aortic aneurysm repair. The MANTA vascular closure device is a novel collagen-based technology designed to close large bore arteriotomies created by devices with an outer diameter ranging from 12F to 25F. In this study, we determined the safety and effectiveness of the MANTA vascular closure device. |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02908880. |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
CONCLUSIONS: In a selected population, this study demonstrated that the MANTA percutaneous vascular closure device can safely and effectively close large bore arteriotomies created by current generation transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, and thoracic endovascular aortic aneurysm repair devices. |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
METHODS AND RESULTS: A prospective, single arm, multicenter investigation in patients undergoing transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, or thoracic endovascular aortic aneurysm repair at 20 sites in North America. The primary outcome was time to hemostasis. The primary safety outcomes were accessed site-related vascular injury or bleeding complications. A total of 341 patients, 78 roll-in, and 263 in the primary analysis cohort, were entered in the study between November 2016 and September 2017. For the primary analysis cohort, transcatheter aortic valve replacement was performed in 210 (79.8%), and percutaneous endovascular abdominal aortic aneurysm repair or thoracic endovascular aortic aneurysm repair was performed in 53 (20.2%). The 14F MANTA was used in 42 cases (16%), and the 18F was used in 221 cases(84%). The mean effective sheath outer diameter was 22F (7.3 mm). The mean time to hemostasis was 65+/-157 seconds with a median time to hemostasis of 24 seconds. Technical success was achieved in 257 (97.7%) patients, and a single device was deployed in 262 (99.6%) of cases. Valve Academic Research Consortium-2 major vascular complications occurred in 11 (4.2%) cases: 4 received a covered stent (1.5%), 3 had access site bleeding (1.1%), 2 underwent surgical repair (0.8%), and 2 underwent balloon inflation (0.8%). |
| 546 ## - LANGUAGE NOTE |
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| Language note |
English |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
*Catheterization, Peripheral |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
*Endovascular Procedures |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
*Hemorrhage/pc [Prevention & Control] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
*Hemostatic Techniques/is [Instrumentation] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
*Transcatheter Aortic Valve Replacement |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
*Vascular Closure Devices |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Aged |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Aged, 80 and over |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Catheterization, Peripheral/ae [Adverse Effects] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Endovascular Procedures/ae [Adverse Effects] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Equipment Design |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Female |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Hemorrhage/et [Etiology] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Hemostatic Techniques/ae [Adverse Effects] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Humans |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Male |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
North America |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Prospective Studies |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Punctures |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Risk Factors |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Time Factors |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Transcatheter Aortic Valve Replacement/ae [Adverse Effects] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Treatment Outcome |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Vascular Closure Devices/ae [Adverse Effects] |
| 651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME |
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| Institution |
MedStar Heart & Vascular Institute |
| 657 ## - INDEX TERM--FUNCTION |
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| Medline publication type |
Journal Article |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Ben-Dor, Itsik |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Bernardo, Nelson L |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Satler, Lowell F |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Waksman, Ron |
| 790 ## - Authors |
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| All authors |
Aziz M, Bacharach JM, Barker C, Barleben A, Ben-Dor I, Bernardo N, Bersin R, Brown D, Campbell J, Chhatriwalla AK, Coady P, Cohen DJ, Dake M, Eng M, Fearon W, Feldman T, Greenbaum A, Guerrero M, Heimansohn D, Kapadia S, Kodali S, Kozak M, Krajcer Z, Krishnaswamy A, Lauck S, Lee JT, Lumsden A, Maor N, Metzger C, Moainie S, Nanjundappa A, Nardone S, O'Neill B, O'Neill WW, Potluri S, Rodriguez R, SAFE MANTA Study Investigators, Sampson A, Sathananthan J, Satler LF, Strickman N, Szerlip M, Waksman R, Webb JG, Wood DA, Yadav P, Zhang M |
| 856 ## - ELECTRONIC LOCATION AND ACCESS |
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| DOI |
<a href="https://dx.doi.org/10.1161/CIRCINTERVENTIONS.119.007258">https://dx.doi.org/10.1161/CIRCINTERVENTIONS.119.007258</a> |
| Public note |
https://dx.doi.org/10.1161/CIRCINTERVENTIONS.119.007258 |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
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| Koha item type |
Journal Article |
| Item type description |
Article |
