Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the MANTA Percutaneous Vascular Closure Device

SAFE MANTA Study Investigators

Research output: Contribution to journalArticle

4 Citations (Scopus)

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. 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%). 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. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02908880.

Original languageEnglish (US)
Pages (from-to)e007258
JournalCirculation. Cardiovascular interventions
Volume12
Issue number7
DOIs
StatePublished - Jul 1 2019

Fingerprint

Thoracic Aortic Aneurysm
Abdominal Aortic Aneurysm
Hemostasis
Safety
Equipment and Supplies
Cohort Studies
Hemorrhage
Vascular System Injuries
Economic Inflation
North America
Sutures
Stents
Blood Vessels
Collagen
Clinical Trials
Technology
Vascular Closure Devices
Clinical Studies
Transcatheter Aortic Valve Replacement
Research

Keywords

  • blood transfusion
  • hemostasis
  • stent
  • transcatheter aortic valve replacement
  • vascular closure device

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the MANTA Percutaneous Vascular Closure Device. / SAFE MANTA Study Investigators.

In: Circulation. Cardiovascular interventions, Vol. 12, No. 7, 01.07.2019, p. e007258.

Research output: Contribution to journalArticle

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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. 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{\%}). 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. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02908880.",
keywords = "blood transfusion, hemostasis, stent, transcatheter aortic valve replacement, vascular closure device",
author = "{SAFE MANTA Study Investigators} and Wood, {David A.} and Zvonimir Krajcer and Janarthanan Sathananthan and Neil Strickman and Chris Metzger and William Fearon and Mark Aziz and Satler, {Lowell F.} and Ron Waksman and Marvin Eng and Samir Kapadia and Adam Greenbaum and Molly Szerlip and David Heimansohn and Andrew Sampson and Paul Coady and Roberto Rodriguez and Amar Krishnaswamy and Lee, {Jason T.} and Itsik Ben-Dor and Sina Moainie and Susheel Kodali and Chhatriwalla, {Adnan K.} and Pradeep Yadav and Brian O'Neill and Mark Kozak and Bacharach, {John M.} and Ted Feldman and Mayra Guerrero and Aravinda Nanjundappa and Robert Bersin and Ming Zhang and Srinivasa Potluri and Colin Barker and Nelson Bernardo and Alan Lumsden and Andrew Barleben and John Campbell and Cohen, {David J.} and Michael Dake and David Brown and Nathaniel Maor and Samuel Nardone and Sandra Lauck and O'Neill, {William W.} and Webb, {John G.}",
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T1 - Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the MANTA Percutaneous Vascular Closure Device

AU - SAFE MANTA Study Investigators

AU - Wood, David A.

AU - Krajcer, Zvonimir

AU - Sathananthan, Janarthanan

AU - Strickman, Neil

AU - Metzger, Chris

AU - Fearon, William

AU - Aziz, Mark

AU - Satler, Lowell F.

AU - Waksman, Ron

AU - Eng, Marvin

AU - Kapadia, Samir

AU - Greenbaum, Adam

AU - Szerlip, Molly

AU - Heimansohn, David

AU - Sampson, Andrew

AU - Coady, Paul

AU - Rodriguez, Roberto

AU - Krishnaswamy, Amar

AU - Lee, Jason T.

AU - Ben-Dor, Itsik

AU - Moainie, Sina

AU - Kodali, Susheel

AU - Chhatriwalla, Adnan K.

AU - Yadav, Pradeep

AU - O'Neill, Brian

AU - Kozak, Mark

AU - Bacharach, John M.

AU - Feldman, Ted

AU - Guerrero, Mayra

AU - Nanjundappa, Aravinda

AU - Bersin, Robert

AU - Zhang, Ming

AU - Potluri, Srinivasa

AU - Barker, Colin

AU - Bernardo, Nelson

AU - Lumsden, Alan

AU - Barleben, Andrew

AU - Campbell, John

AU - Cohen, David J.

AU - Dake, Michael

AU - Brown, David

AU - Maor, Nathaniel

AU - Nardone, Samuel

AU - Lauck, Sandra

AU - O'Neill, William W.

AU - Webb, John G.

PY - 2019/7/1

Y1 - 2019/7/1

N2 - 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. 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%). 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. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02908880.

AB - 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. 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%). 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. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02908880.

KW - blood transfusion

KW - hemostasis

KW - stent

KW - transcatheter aortic valve replacement

KW - vascular closure device

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