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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02521948
• Date of registration: 07/08/2015
• Prospective Registration: No
• Primary sponsor: Essential Medical, Inc.
• Public title: Clinical Study to Evaluate the Safety and Performance of MANTA Vascular Closure Device
• Scientific title: Clinical Study to Evaluate the Safety and Performance of MANTA Vascular Closure Device
• Date of first enrolment: July 2015
• Target sample size: 50
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02521948
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Italy, Netherlands

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Femoral Arteriotomy Closure

Intervention(s)

Device: MANTA Vascular Closure Device

Primary Outcome(s)

Hemostasis Success [Time Frame: Within the first 10 minutes of cutting the MANTA suture]

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]

Secondary Outcome(s)

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.]

Secondary ID(s)

PSD-051

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 29/10/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02521948