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

Not Applicable

Completed

• Conditions: Femoral Arteriotomy Closure
• Interventions: Device: MANTA Vascular Closure Device

• Registration Number: NCT02521948
• Lead Sponsor: Essential Medical, Inc.

Brief 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.

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-08-07
• Study First Submitted QC: 2015-08-10
• Study First Posted: 2015-08-13
• Primary Completion: 2016-02
• Study Completion: 2016-05
• Results First Submitted: 2017-07-17
• Status Verified: 2018-02
• Results First Submitted QC: 2018-02-07
• Last Update Submitted: 2018-02-07
• Results First Posted: 2018-10-29
• Last Update Posted: 2018-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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
• Patients with a known bleeding disorder including thrombocytopenia (platelet count <150 x 10^9/L), thrombasthenia, hemophilia, or von Willebrand's disease
• Patients with a femoral artery <6 mm in diameter, femoral artery stenosis resulting in a vessel diameter <6 mm, or patients with severe peripheral vascular disease
• Common femoral artery with fluoroscopically visible calcium, as determined by Angio CT, precluding safe access in the opinion of the investigator
• Patients with allergy to bovine materials, collagen and/or collagen products, or polyglycolic or polylactic acid polymers
• Patients who cannot adhere to or complete the investigational protocol for any reason including but not limited to geographical residence or life threatening disease
• Patients with Sheehan Disability Scale (SDS) scores >12
• Patients punctured through a vascular graft
• Patients with known allergy to stainless steel or nickel
• Patients who have acute ST-elevation myocardial infarction within 48 hours prior to procedure
• Patients with unilateral or bilateral lower extremity amputation
• Patients with renal insufficiency (serum creatinine >2.5 mg/dl)
• Patients undergoing therapeutic thrombolysis
• Patients who are unable to ambulate at baseline
• Patients undergoing an interventional procedure whom are being treated with warfarin
• Patients requiring a continuous oral anticoagulation therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MANTA Vascular Closure Device	MANTA Vascular Closure Device	The MANTA device, developed by Essential Medical, Inc., 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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Major Complications	Within either the first 30 days (plus or minus 7 days) after the procedure or the first 60 days (plus or minus 14 days) after the procedure	Composite endpoint that includes any of the following adverse events: * Access site-related bleeding requiring blood transfusion or vascular repair; * Vascular injury requiring repair (e.g. perforation, dissection, arterio-venous fistula, retroperitoneal bleed, pseudoaneurysm); * Femoral artery stenosis at the access site requiring intervention; * New ipsilateral lower extremity ischemia causing a threat to the viability of the limb; * Access site-related infection requiring intravenous antibiotics and/or extended hospitalization; * New onset access site-related neuropathy in the ipsilateral lower extremity requiring surgical repair; * Permanent access site-related nerve injury (lasting\>30 days)
Hemostasis Success	Within the first 10 minutes of cutting the MANTA suture	Hemostasis at the puncture site within 10 minutes of cutting the MANTA suture without need for manual or mechanical compression and without later re-bleeding (trivial or subcutaneous oozing will not be considered bleeding; light finger pressure to control subcutaneous oozing will not be considered manual compression)

Secondary Outcome Measures

Name	Time	Method
Time to Hemostasis	Time between MANTA deployment and first observed and confirmed arterial hemostasis up to ten (10) minutes after MANTA device is deployed.	The elapsed time between MANTA deployment (withdrawal of sheath from artery) and first observed and confirmed arterial hemostasis (no or minimal subcutaneous oozing and the absence of expanding or developing hematoma).

Trial Locations

Locations (3)

St. Antonius Ziekenhuis; 🇳🇱 Nieuwegein, Netherlands

Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands

San Raffaele Hospital; 🇮🇹 Milan, Italy