Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the MANTA Vascular Closure Device During Percutaneous EVAR and TEVAR Procedures. (Record no. 5194)

MARC details
000 -LEADER
fixed length control field 04739nam a22006737a 4500
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 200709s20202020 xxu||||| |||| 00| 0 eng d
022 ## - INTERNATIONAL STANDARD SERIAL NUMBER
International Standard Serial Number 1526-6028
024 ## - OTHER STANDARD IDENTIFIER
Standard number or code 10.1177/1526602820912224 [doi]
040 ## - CATALOGING SOURCE
Original cataloging agency Ovid MEDLINE(R)
099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC)
PMID 32193971
245 ## - TITLE STATEMENT
Title Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the MANTA Vascular Closure Device During Percutaneous EVAR and TEVAR Procedures.
251 ## - Source
Source Journal of Endovascular Therapy. 27(3):414-420, 2020 Jun.
252 ## - Abbreviated Source
Abbreviated source J Endovasc Ther. 27(3):414-420, 2020 Jun.
252 ## - Abbreviated Source
Former abbreviated source J Endovasc Ther. :1526602820912224, 2020 Mar 20
253 ## - Journal Name
Journal name Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Year 2020
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Manufacturer FY2020
265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE]
Publication status aheadofprint
265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE]
Publication status ppublish
266 ## - Date added to catalog
Date added to catalog 2020-07-09
268 ## - Previous citation
-- Journal of Endovascular Therapy. :1526602820912224, 2020 Mar 20
520 ## - SUMMARY, ETC.
Abstract Purpose: To evaluate the safety and effectiveness of the MANTA percutaneous vascular closure device in patients undergoing percutaneous endovascular aneurysm repair (PEVAR) or thoracic endovascular aortic repair (TEVAR). Materials and Methods: The SAFE MANTA Study (ClinicalTrials.gov identifier NCT02908880) was a prospective, single-arm, multicenter trial in patients undergoing endovascular interventions using large-bore sheaths (transcatheter aortic valve replacement, PEVAR, or TEVAR) at 20 sites in North America. Patient selection intended to test the MANTA device in populations without morbid obesity, severe calcification, or a severely scarred femoral access area. Of the 263 patients enrolled in the primary analysis cohort, 53 (20.2%) patients (mean age 74.9+/-8.9 years; 41 men) underwent PEVAR (n=51) or TEVAR (n=2) procedures and form the cohort for this subgroup analysis. Per protocol a single MANTA device was deployed in all PEVAR/TEVAR cases. Results: The mean time to hemostasis in the PEVAR/TEVAR cohort was 35+/-91 seconds, with a median time of 19 seconds vs 24 seconds in the overall SAFE MANTA population. The MANTA device met the definition for technical success in 52 (98%) of 53 PEVAR/TEVAR cases compared with 97.7% in the overall SAFE MANTA population. One (1.9%) major complication (access-site stenosis) occurred in this subgroup compared to 14 (5.3%) events in the SAFE population. In the PEVAR/TEVAR group, 1 pseudoaneurysm was noted prior to discharge, another at 30-day follow-up, and one at 60 days. One (1.9%) of the 3 minor pseudoaneurysms was treated with ultrasound-guided compression and the other 2 required no treatment. Conclusion: The MANTA device demonstrated a short time to hemostasis and low complication rates compared with published literature results of other percutaneous closure devices. Time to hemostasis and complication rates were comparable between the PEVAR/TEVAR patients and the full SAFE MANTA study cohort. The MANTA device provides reliable closure with a single percutaneous device for PEVAR/TEVAR procedures.
546 ## - LANGUAGE NOTE
Language note English
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Aorta, Thoracic/su [Surgery]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Aortic Aneurysm/su [Surgery]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Blood Vessel Prosthesis Implantation
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Catheterization, Peripheral
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Endovascular Procedures
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Hemorrhage/pc [Prevention & Control]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Hemostasis
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Hemostatic Techniques/is [Instrumentation]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Vascular Closure Devices
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Aged
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Aged, 80 and over
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Aorta, Thoracic/dg [Diagnostic Imaging]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Aortic Aneurysm/dg [Diagnostic Imaging]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Blood Vessel Prosthesis Implantation/ae [Adverse Effects]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Blood Vessel Prosthesis Implantation/is [Instrumentation]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Catheterization, Peripheral/ae [Adverse Effects]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Endovascular Procedures/ae [Adverse Effects]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Endovascular Procedures/is [Instrumentation]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Female
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Hemorrhage/bl [Blood]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Hemorrhage/et [Etiology]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Hemostatic Techniques/ae [Adverse Effects]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Humans
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Male
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element North America
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Prospective Studies
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Punctures
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Time Factors
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Treatment Outcome
651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME
Institution MedStar Heart & Vascular Institute
657 ## - INDEX TERM--FUNCTION
Medline publication type Journal Article
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Bernardo, Nelson L
790 ## - Authors
All authors Aziz M, Bacharach JM, Bernardo N, Campbell J, Dake MD, Krajcer Z, Lee JT, Lumsden A, Metzger C, Nanjundappa A, Nardone S, Strickman N, Wood DA
856 ## - ELECTRONIC LOCATION AND ACCESS
DOI <a href="https://dx.doi.org/10.1177/1526602820912224">https://dx.doi.org/10.1177/1526602820912224</a>
Public note https://dx.doi.org/10.1177/1526602820912224
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Koha item type Journal Article
Item type description Article
Holdings
Withdrawn status Lost status Damaged status Not for loan Collection Home library Current library Date acquired Total Checkouts Full call number Barcode Date last seen Price effective from Koha item type
          MedStar Authors Catalog MedStar Authors Catalog 07/09/2020   32193971 32193971 07/09/2020 07/09/2020 Journal Article

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