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 for purposes of obtaining a CE Mark…
ID
Source
Brief title
Condition
- Other condition
- Heart failures
- Vascular therapeutic procedures
Synonym
Health condition
Aandoeningen aan de hartklep
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Safety Endpoint: The rate of Major Complications, composite endpoint
that includes any of the following adverse events:
* Access site-related bleeding requiring blood transfusion or vascular repair
* Vascular injury requiring repair (e.g. perforation dissection, arterio-venous
fistula, retroperitoneal bleed, pseudoaneurysm)
* Femoral artery stenosis at the access site requiring intervention
* New ipsilateral lower extremity ischemia causing a threat to the viability of
the limb
* Access site-related infection requiring intravenous antibiotics and/or
extended hospitalization
* New onset access site-related neuropathy in the ipsilateral lower extremity
requiring surgical repair
* Permanent access site-related nerve injury (lasting>30 days)
. Primary Effectiveness Endpoint: The rate of Hemostasis Success
Secondary outcome
Secondary Safety Endpoint: The rate of Minor Complications within 30±7 days
following the procedure, composite endpoint that includes any of the following
adverse events:
* Access site-related bleeding requiring > 30 minutes to achieve hemostasis
* Access site-related hematoma > 6 cm
* Late access site-related bleeding (following hospital discharge)
* Ipsilateral lower extremity arterial emboli
* Ipsilateral deep vein thrombosis
* Access site-related vessel laceration
* Access site wound dehiscence
* Localized access site infection treated with intramuscular or oral antibiotics
* Arteriovenous fistula not requiring treatment
* Pseudoaneurysm requiring thrombin injection or fibrin adhesive injection
* Pseudoaneurysm not requiring treatment
* New onset access site-related neuropathy in the ipsilateral lower extremity
not requiring surgical repair
* Ipsilateral pedal pulse diminished by two grades or transiently lost
* Any other adverse event that is definitely or probably device-related or
access-site related
Secondary Effectiveness Endpoints: Time to Hemostasis (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)), Time to Ambulation (The elapsed
time between MANTA deployment (withdrawal of sheath from artery) and when
ambulation is achieved (patient standing and walking at least 20 feet without
re-bleeding)) and Treatment Success (MANTA delivery system successfully
deployed and hemostasis achieved by MANTA alone or with adjunctive compression
(manual or mechanical) with freedom from Major Complications).
Background summary
The advent of percutaneous cardiac and peripheral procedures performed through
large bore arteriotomies, such as transcatheter aortic valve replacement
(TAVR), endovascular aneurysm repair (EVAR), and balloon aortic valvuloplasty
(BAV), demonstrates a need for a safe and effective vascular closure device to
replace the current standard of care of surgical cut-down/repair or use of
multiple small bore suture-mediated closure devices that were not designed for
large bore punctures.
Study objective
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 for purposes of
obtaining a CE Mark in the EU.
Study design
Prospective, multi-center, open-label, single-arm clinical investigation
Intervention
In stead of conventional closure techniques, the MANTA 14F or 18F is used
(dependent on size of sheath used, determination of physician).
Study burden and risks
Use of the MANTA device carries risk from procedural error, inherent use
hazards, and device failure. Essential Medical, Inc. has taken measures to
ensure the device is designed, manufactured and tested appropriately to
mitigate and control these risks through systematic risk analysis, in-process
controls and final inspection, labeling, instructions for use, and post-market
surveillance. As a result, the residual risk is as low as possible.
Risks from the clinical study itself are negligible. The only non-standard
test required by the study protocol is duplex ultrasound of the femoral artery
at baseline, prior to discharge and at follow-up. Ultrasound is a non-invasive
standard diagnostic test that carries almost no risk, apart from the
possibility of minimal patient discomfort from the pressure of the transducer.
All of the other study procedures are standard of care for interventional
peripheral and cardiac procedures.
In conclusion, the potential benefits of the MANTA device are expected to
outweigh the aforementioned mitigated risks and exceed or meet the performance
of current treatment methods, and the study itself carries almost no additional
risk. Therefore, the clinical study is justified by the risk/benefit ratio
East King Street 227
Malvern PA 19355
US
East King Street 227
Malvern PA 19355
US
Listed location countries
Age
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, 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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL52577.078.15 |