Prospective Clinical Registry Evaluating Contemporary MANTA Outcomes

Femoral Arteriotomy Closure Clinical Trial

— ACCESS MANTA  

Official title:

Prospective Clinical Registry Evaluating Contemporary MANTA Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05936996
• Other study ID #: ST-3659
• Status: Recruiting
• Start date: November 15, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: January 2024
• Source: Essential Medical, Inc.
• Contact: Farah Jarjous
• Phone: +1.734.309.1312
• Email: farah.jarjous[@]teleflex.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This is an observational study designed to evaluate the safety and clinical outcomes of the MANTA® Vascular Closure Device (VCD) (the MANTA® Device) in TAVR procedures. The study will enroll participants who are undergoing a TAVR procedure. The purpose of this study is to examine and collect data on outcomes of contemporary MANTA® large bore closure in standard of care (SOC) TAVR procedures with on-label use of the MANTA® device including appropriate patient selection and proper vascular access.

Description:

In the U.S. and Canada, the MANTA® Vascular Closure Device is indicated for closure of femoral arterial access sites while reducing time to hemostasis following the use of 10-20F devices or sheaths (12-25F OD) in endovascular catheterization procedures. In Israel, the 14F MANTA® is indicated for closure of femoral arterial access sites following the use of 10-14F devices or sheaths (maximum OD/profile of 18F), and the 18F MANTA® device is indicated for closure of femoral arterial access sites following the use of 15-18F devices or sheaths (maximum OD/profile of 25F). The purpose of the study is to examine and collect data on outcomes of contemporary MANTA® large bore closure in standard of care (SOC) TAVR procedures with on-label use of the MANTA® device including appropriate patient selection and proper vascular access.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: March 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Candidate meets criteria for on-label use of MANTA® VCD as specified in the country-specific MANTA® VCD Instructions for Use (IFU), per judgement of the investigator.

• Age =21 years

Exclusion Criteria:

• Unable or unwilling to give informed consent or unwilling to complete follow-up assessments.

Related Conditions & MeSH terms

• Femoral Arteriotomy Closure

Intervention

Device:
• MANTA Vascular Closure Device
The MANTA® Vascular Closure Device consists of a 14F or 18F MANTA® Closure Device, a 14F or 18F Sheath with Introducer, and an 8F Depth Locator. In the U.S. and Canada, the MANTA® Vascular Closure Device is indicated for closure of femoral arterial access sites while reducing time to hemostasis following the use of 10-20F devices or sheaths (12-25F OD) in endovascular catheterization procedures.

Locations

Country	Name	City	State
United States	University at Buffalo	Buffalo	New York
United States	Henry Ford Health	Detroit	Michigan
United States	Baptist Health Medical Center-Jacksonville	Jacksonville	Florida
United States	Mount Sinai Hospital	New York	New York
United States	Baylor Scott & White - Round Rock	Round Rock	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Essential Medical, Inc.	Essential Medical LLC a subsidiary of Teleflex, Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of VARC-3 Major & Minor Vascular complications		within 30 days of TAVR procedure
Primary	Time to Hemostasis	The elapsed time between MANTA® deployment and first observed and confirmed arterial hemostasis	During the procedure
Secondary	Additional interventions: Required at large bore access site to address complications	The percentage of subjects with additional interventions required at large bore access site to address bleeding or other large bore access site complications (e.g., bare or covered stent or surgical repair), within 30 days following the procedure	within 30 days following the procedure
Secondary	Technical Success:	The percentage of subjects in whom closure is obtained with the MANTA® VCD without the use of unplanned endovascular or surgical intervention	During the procedure
Secondary	Ambulation Success:	The percentage of a previously ambulatory subjects (until day of TAVI) who are able to ambulate for at least 20 feet/6 meters without re-bleeding.	During procedure admission
Secondary	Treatment Success:	The percentage of subjects in whom the time to Hemostasis =10 minutes and have no Large Bore Access Related Major VARC-3 complications within 30 days.	within 30 days of TAVR procedure