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Clinical Study to Evaluate the Safety and Performance of MANTA Vascular Closure Device | Clinical Trials | Clareo Health

COMPLETEDNA

Clinical Study to Evaluate the Safety and Performance of MANTA Vascular Closure Device

NCT02521948•Essential Medical, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the safety and performance of the MANTA Vascular Closure Device (VCD) to close the arteriotomy following percutaneous cardiovascular procedures utilizing large bore sheaths for purposes of supporting a CE Mark (Conformite Europeenne--"European Conformity") and other regulatory submissions. The study will assess whether the MANTA VCD is safe and performs as intended for large-bore vascular closure after interventional procedures.

Detailed Description

The purpose of this study is to evaluate the safety and performance of MANTA in achieving hemostasis in femoral arterial access sites in patients undergoing percutaneous transcatheter interventional procedures using a 10-18F procedure sheath (such as Transcather Aortic Valve Replacement (TAVR), Balloon Aortic Valvuloplasty (BAV) and Endovascular Aneurysm Repair (EVAR)) for purposes of obtaining a CE Mark in the European Union. The study will evaluate hemostasis success, time to hemostasis and ambulation, treatment success, and the rate of access-site-related complications in comparison to published literature on other hemostasis techniques for closing these large bore punctures (primarily, surgical closure and suture-mediated percutaneous closure.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Candidate for non-emergent transcatheter interventional procedure via a 10-18F femoral sheath (e.g., transcatheter aortic valve replacement \[TAVR\], balloon aortic valvuloplasty \[BAV\], Abdominal Aortic Aneurysm \[AAA\] stent-graft placement)
•Eligible for sheath removal in the catheterization lab
•Age ≥18 years
•Understand and sign the study specific written informed consent form
•Able and willing to fulfill the follow-up requirements
•In the Investigator's opinion, the patient is suitable for the MANTA vascular closure device, conventional hemostasis techniques and participation in an investigational trial
•Patients of childbearing age with Negative Pregnancy Test within 7 days of procedure

Exclusion Criteria

•Baseline Exclusions:
•Patients who are known to be pregnant or lactating
•Patients who are immunocompromised or with pre-existing autoimmune disease
•Patients who have a systemic infection or a local infection at or near the access site
•Patients requiring a re-puncture at a site previously punctured within 48 hours
•Patients with significant anemia (hemoglobin \< 6.5 mmol/l, Hct\<30)
•Patients who are morbidly obese or cachectic (BMI \>40 or \<20)
•Patients with Systolic Blood Pressure \>180 mmHg, unless Systolic Pressure can be lowered by pharmacological agents prior to closure
•Patients who are currently participating in another clinical trial of an investigational device or drug that has not concluded the follow-up period
•Patients in whom an antegrade puncture is performed or planned
+15 more criteria

Locations (3)

San Raffaele Hospital

Milan, Italy

St. Antonius Ziekenhuis

Nieuwegein, Netherlands

Erasmus Medical Center

Rotterdam, Netherlands

Key Dates

Start Date

July 1, 2015

Primary Completion Date

February 1, 2016

Completion Date

May 1, 2016

Last Updated

October 29, 2018

Enrollment

ACTUAL participants

Conditions

Femoral Arteriotomy Closure

Interventions

MANTA Vascular Closure Device

DEVICE

The Ladera Suture-Mediated Large Bore Closure Study

NCT06851481

Vascular ClosureFemoral Arteriotomy Closure

View study

ACTIVE_NOT_RECRUITINGNA

The Ladera Large Bore Closure Feasibility Study

NCT06358157

Vascular ClosureFemoral Arteriotomy Closure

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 29, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Clinical Study to Evaluate the Safety and Performance of MANTA Vascular Closure Device

Inclusion Criteria

Exclusion Criteria

The Ladera Suture-Mediated Large Bore Closure Study

The Ladera Large Bore Closure Feasibility Study

X-Seal EU Post-Market Clinical Follow-Up Protocol