- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02521948
Clinical Study to Evaluate the Safety and Performance of MANTA Vascular Closure Device
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Milan, Italy
- San Raffaele Hospital
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Nieuwegein, Netherlands
- St. Antonius Ziekenhuis
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Rotterdam, Netherlands
- Erasmus Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Major Complications
Time Frame: 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
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Composite endpoint that includes any of the following adverse events:
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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
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Hemostasis Success
Time Frame: Within the first 10 minutes of cutting the MANTA suture
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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)
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Within the first 10 minutes of cutting the MANTA suture
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Time to Hemostasis
Time Frame: Time between MANTA deployment and first observed and confirmed arterial hemostasis up to ten (10) minutes after MANTA device is deployed.
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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).
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Time between MANTA deployment and first observed and confirmed arterial hemostasis up to ten (10) minutes after MANTA device is deployed.
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Kadakia MB, Herrmann HC, Desai ND, Fox Z, Ogbara J, Anwaruddin S, Jagasia D, Bavaria JE, Szeto WY, Vallabhajosyula P, Li R, Menon R, Kobrin DM, Giri J. Factors associated with vascular complications in patients undergoing balloon-expandable transfemoral transcatheter aortic valve replacement via open versus percutaneous approaches. Circ Cardiovasc Interv. 2014 Aug;7(4):570-6. doi: 10.1161/CIRCINTERVENTIONS.113.001030. Epub 2014 Jul 15.
- Ben-Dor I, Looser P, Bernardo N, Maluenda G, Torguson R, Xue Z, Lindsay J, Pichard AD, Satler LF, Waksman R. Comparison of closure strategies after balloon aortic valvuloplasty: suture mediated versus collagen based versus manual. Catheter Cardiovasc Interv. 2011 Jul 1;78(1):119-24. doi: 10.1002/ccd.22940.
- Nelson PR, Kracjer Z, Kansal N, Rao V, Bianchi C, Hashemi H, Jones P, Bacharach JM. A multicenter, randomized, controlled trial of totally percutaneous access versus open femoral exposure for endovascular aortic aneurysm repair (the PEVAR trial). J Vasc Surg. 2014 May;59(5):1181-93. doi: 10.1016/j.jvs.2013.10.101. Epub 2014 Jan 17.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PSD-051
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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