MANTA Percutaneous Vascular Closure Device - The SAFE MANTA Study (SAFE_MANTA)
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|ClinicalTrials.gov Identifier: NCT02908880|
Recruitment Status : Completed
First Posted : September 21, 2016
Results First Posted : May 7, 2019
Last Update Posted : September 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Femoral Arteriotomy Closure||Device: MANTA vascular closure device||Not Applicable|
The MANTA device is a VCD intended for use in catheterization laboratories following percutaneous cardiac or peripheral procedures that use the retrograde common femoral artery access route for large bore (10-18F ID) interventional devices. The function of MANTA is to percutaneously close the puncture in the artery wall (arteriotomy) through which the catheters were inserted for the procedure.
The study is being conducted to demonstrate the safety and effectiveness of MANTA in achieving hemostasis in femoral arterial access sites in subjects undergoing percutaneous transcatheter interventional procedures using a large-bore procedure sheath.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||263 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pivotal Clinical Study to EvaluAte the SaFety and Effectiveness of MANTA Vascular Closure Device|
|Study Start Date :||December 2016|
|Actual Primary Completion Date :||October 2017|
|Actual Study Completion Date :||December 2017|
Experimental: MANTA vascular closure device
Open label, single arm study using the MANTA device, developed by Essential Medical, Inc. MANTA is a vascular closure device (VCD) intended for use in catheterization laboratories following percutaneous cardiac or peripheral procedures that use the retrograde common femoral artery access route for large bore (10-18F) interventional devices.
Device: MANTA vascular closure device
The appropriate size of MANTA closure device will be selected and used for the closure of femoral arterial access sites following the use of 10-14F devices or sheaths or the use of 15-18F devices or sheaths.
Other Name: MANTA
- Time to Hemostasis [ Time Frame: During access site closure, usually within an hour of starting the procedure. ]The elapsed time between withdrawal of MANTA sheath/device from artery and first observed and confirmed arterial hemostasis (no or minimal subcutaneous oozing and the absence of expanding or developing hematoma).
- Number of Patients With Major Complications, Within 30 Days of Procedure [ Time Frame: Up to 30 days after procedure ]IDE Protocol-Defined Major Complications analyzed on a per-patient basis
- Technical Success [ Time Frame: Within 6 hours after deployment of the MANTA device ]Percutaneous vascular closure obtained with the MANTA device without the use of unplanned endovascular or surgical intervention
- Number of Patients With VARC-2 Major Vascular Complications, Adapted From the VARC-2 Criteria, Within 30 Days of Procedure [ Time Frame: Up to 30 days after procedure ]Incidence of VARC-2 Major Vascular Complications, analyzed on a per-patient basis
- Number of Patients With Minor Complications, Within 30 Days of Procedure [ Time Frame: Up to 30 days after procedure ]Incidence of IDE Protocol-defined Minor Complications, analyzed on a per-patient analysis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02908880
|Principal Investigator:||David Wood, MD||St. Paul's Hospital|
|Principal Investigator:||Zvonimir Krajcer, MD||St. Luke's Episcopal|