Clinical Study to Evaluate the Safety and Performance of MANTA Vascular Closure Device
- Conditions
- Aandoeningen aan de hartklepCardiac diseaseVascular intervention1001928010003184
- Registration Number
- NL-OMON42594
- Lead Sponsor
- Essential Medical Inc.
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 35
* 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
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, Hematocrit<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 <100 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 polyactic 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 punctured through a vascular graft
* Patients with known allergy to stainless steel or nickel
* Patients who have acute ST-elevation MI within 48 hours prior to the procedure
* Patients with unilateral or bilateral lower extremity amputation
* Patients with renal insufficiency (serum creatinine > 2,5mg/dl)
* Patients undergoing therapeutic thrombolysis
* Patients who are unable to ambulate at baseline (necessary to determine time-to-ambulation)
* Patients undergoing an interventional procedure whom are being treated with warfarin
* Patients requiring a continuous oral anticoagulation therapy or patients with INR >1.8. Patients may be admitted into the study if oral anticoagulation therapy is stopped prior to procedure and resumed after the procedure.;Intra-procedure exclusions:
* Patients with puncture sites believed to be in the profunda femoris, superficial femoral artery, or at the bifurcation of the arteries
* Femoral arteries that are suspected to have experienced a back wall puncture or that underwent > one (1) arterial puncture during the catheterization procedure
* Patients in whom the puncture site is located above the most inferior border of the epigastric artery (IEA) and/or above the inguinal ligament based upon bony landmarks, since such a puncture site may result in a retroperitoneal hematoma/bleed
* Patients in whom bacterial contamination of the procedure sheath or surrounding tissues may have occurred as this may result in infection
* Patients having a complication(s) at the femoral artery access site pre-sheath removal including hematoma, pseudoaneurysm, or arterio-venous fistula
* Patients whose ACT is >250 seconds prior to removal of the guiding catheter
* Patients with marked turtuosity of the femoral or iliac artery
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Safety Endpoint: The rate of Major Complications, composite endpoint<br /><br>that includes any of the following adverse events:<br /><br>* Access site-related bleeding requiring blood transfusion or vascular repair<br /><br>* Vascular injury requiring repair (e.g. perforation dissection, arterio-venous<br /><br>fistula, retroperitoneal bleed, pseudoaneurysm)<br /><br>* Femoral artery stenosis at the access site requiring intervention<br /><br>* New ipsilateral lower extremity ischemia causing a threat to the viability of<br /><br>the limb<br /><br>* Access site-related infection requiring intravenous antibiotics and/or<br /><br>extended hospitalization<br /><br>* New onset access site-related neuropathy in the ipsilateral lower extremity<br /><br>requiring surgical repair<br /><br>* Permanent access site-related nerve injury (lasting>30 days)<br /><br><br /><br>. Primary Effectiveness Endpoint: The rate of Hemostasis Success</p><br>
- Secondary Outcome Measures
Name Time Method