N/A
N=50
Clinical Study to Evaluate the Safety and Performance of MANTA Vascular Closure Device
Femoral Arteriotomy Closure
Bottom Line
View on ClinicalTrials.gov: NCT02521948 ↗Enrolled (actual)
50
Serious AEs
23.0%
Results posted
Oct 2018
Primary outcome: Primary: Number of Participants With Major Complications — 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MANTA Vascular Closure Device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Essential Medical, Inc.
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Major Complications |
3 | — |
| PRIMARY Hemostasis Success |
47; 16; 31 | — |
| SECONDARY Time to Hemostasis |
2.38 | — |
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.
Eligibility 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 40 or 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 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
Data sourced from ClinicalTrials.gov (NCT02521948). 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.