MANTA Vascular Closure Device for Femoral Artery Closure

Phase-Based Progress Estimates
Baylor Scott & White, Round Rock, TXFemoral Artery ClosureMANTA Vascular Closure Device - Device
All Sexes
What conditions do you have?

Study Summary

This trial demonstrates the safety of the MANTA Vascular Closure Device, which uses ultrasound to guide closure of the femoral artery, in patients undergoing elective TAVR procedures.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: within 30 days

During procedure admission
Number of subjects with Ambulation Success
Time to Ambulation
During the procedure
Procedure Time
Time to Hemostasis
within 30 days
Number of patients with Technical Success
Rate of any large bore access-site related VARC-2 major vascular complication
Rate of any large bore access-site related VARC-2 minor vascular complication
Treatment Success

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Ultrasound Closure
1 of 1

Experimental Treatment

180 Total Participants · 1 Treatment Group

Primary Treatment: MANTA Vascular Closure Device · No Placebo Group · N/A

Ultrasound Closure
Experimental Group · 1 Intervention: MANTA Vascular Closure Device · Intervention Types: Device
First Studied
Drug Approval Stage
How many patients have taken this drug
MANTA Vascular Closure Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: within 30 days

Who is running the clinical trial?

TeleflexIndustry Sponsor
19 Previous Clinical Trials
4,265 Total Patients Enrolled
Essential Medical, Inc.Lead Sponsor
4 Previous Clinical Trials
860 Total Patients Enrolled
David WoodPrincipal InvestigatorVancouver General Hospital
Vijay IyerPrincipal InvestigatorUniversity at Buffalo

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

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Frequently Asked Questions

What is today's patient recruitment goal for this research project?

"The sponsor, Teleflex, needs to enroll 180 eligible patients from various clinical trial sites - including Washington Hospital Center in Washington, District of Columbia and Sentara Northern Virginia Medical Center in Woodbridge, Virginia - in order to complete the study." - Anonymous Online Contributor

Unverified Answer

If I'm interested in participating in this trial, how many different places can I go to?

"This study is being conducted in several hospitals, including Washington Hospital Center, Sentara Northern Virginia Medical Center, and University of Buffalo." - Anonymous Online Contributor

Unverified Answer

Are there any presently open vacancies for patients in this experiment?

"The trial is still recruiting patients, as indicated by the 8/24/2022 edit date on The listing for this study was first posted on 8/9/2022." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.