N/A
N=263
MANTA Percutaneous Vascular Closure Device - The SAFE MANTA Study
Femoral Arteriotomy Closure
Bottom Line
View on ClinicalTrials.gov: NCT02908880 ↗Enrolled (actual)
263
Serious AEs
26.6%
Results posted
May 2019
Primary outcome: Primary: Time to Hemostasis — 65.4 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MANTA vascular closure device (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Essential Medical, Inc.
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Hemostasis |
65.4 | — |
| PRIMARY Number of Patients With Major Complications, Within 30 Days of Procedure |
14 | — |
| SECONDARY Technical Success |
257 | — |
| SECONDARY Number of Patients With VARC-2 Major Vascular Complications, Adapted From the VARC-2 Criteria, Within 30 Days of Procedure |
11 | — |
| SECONDARY Number of Patients With Minor Complications, Within 30 Days of Procedure |
7 | — |
Summary
Research study which tests the safety and effectiveness of a new vascular closure device to close the femoral access puncture that is created in patients who require this form of access in order to perform the planned procedure. The MANTA device is expected to seal the femoral access puncture in less than 1 minute. This may result in less blood loss and a shorter time to walking compared to alternative closure means. Use of the MANTA device in this study is experimental. All other parts of the procedure involve standard medical care.
Eligibility Criteria
Inclusion Criteria
- Candidate for elective or planned (i.e., not emergent or urgent) percutaneous transcatheter interventional procedure via a 10-18F size retrograde common femoral artery approach (i.e., transcatheter aortic valve implantation [TAVI], endovascular aneurysm repair [EVAR], Impella® use)
- Vessel size would allow for access for the MANTA device as determined by baseline CTA: minimum vessel diameter 5mm for the 14F MANTA and 6mm for the 18F MANTA
- Eligible for sheath removal in the catheterization lab
- Age ≥21 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, patient is suitable for the MANTA vascular closure device, conventional hemostasis techniques and participation in an investigational trial
Exclusion Criteria
- Known to be pregnant or lactating
- Immunocompromised or with pre-existing autoimmune disease
- Systemic infection or a local infection at or near the access site
- Significant anemia (hemoglobin 40 kg/m2 or <20 kg/m2)
- Known bleeding disorder including thrombocytopenia (platelet count <100,000 cells/UL), thrombasthenia, hemophilia, or von Willebrand disease
- Allergy to bovine materials or any other device material, including collagen and/or collagen products, polyglycolic or polylactic acid, stainless steel or nickel
- Femoral artery puncture in target groin within the prior 14 days
- Previous iliofemoral intervention in region of access site, including but not limited to prior atherectomy, stenting, surgical or grafting procedures in the access area
- Patients who have undergone use of an intra-aortic balloon pump through the arterial access site within 30 days prior to the baseline evaluation
- Patients who are not mobile and are confined to a wheelchair or bed
- NYHA class IV heart failure
- Patients who have already participated in the IDE study
- Currently participating in another clinical trial of an unapproved investigational device or drug that has not concluded the follow-up period
- Patient cannot adhere to or complete the investigational protocol for any reason including but not limited to geographical residence, psychiatric condition or life threatening disease
Data sourced from ClinicalTrials.gov (NCT02908880). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.