Femoral Arteriotomy Closure
Conditions
Keywords
MANTA, Arterial Closure Device, Large Bore Closure Device
Brief 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.
Detailed description
The purpose of this study is 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 (such as Transcather Aortic Valve Replacement (TAVR), Balloon Aortic Valvuloplasty (BAV) and Endovascular Aneurysm Repair (EVAR)) for purposes of obtaining a CE Mark in the European Union. The study will evaluate hemostasis success, time to hemostasis and ambulation, treatment success, and the rate of access-site-related complications in comparison to published literature on other hemostasis techniques for closing these large bore punctures (primarily, surgical closure and suture-mediated percutaneous closure.
Interventions
The MANTA device developed by Essential Medical, Inc., is a vascular closure device (VCD) intended for use in catheterization laboratories following percutaneous cardiac or peripheral procedures that use the retrograde common femoral artery access route for large bore (10-18F) interventional devices.
Sponsors
Essential Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Major Complications | 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 | 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) |
| Hemostasis Success | Within the first 10 minutes of cutting the MANTA suture | Hemostasis at the puncture site within 10 minutes of cutting the MANTA suture without need for manual or mechanical compression and without later re-bleeding (trivial or subcutaneous oozing will not be considered bleeding; light finger pressure to control subcutaneous oozing will not be considered manual compression) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Hemostasis | Time between MANTA deployment and first observed and confirmed arterial hemostasis up to ten (10) minutes after MANTA device is deployed. | 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). |
Countries
Italy, Netherlands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MANTA Vascular Closure Device (Total) The MANTA device, developed by Essential Medical, Inc., is a vascular closure device (VCD) intended for use in catheterization laboratories following percutaneous cardiac or peripheral procedures that use the retrograde common femoral artery access route for large bore (10-18F) interventional devices. | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Death | 4 |
| Overall Study | Did not attend one or both follow-ups | 6 |
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | MANTA Vascular Closure Device (Total) |
|---|---|
| Age, Continuous | 79.5 years STANDARD_DEVIATION 8.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 50 Participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 50 | 0 / 50 |
| other Total, other adverse events | 45 / 50 | 32 / 50 |
| serious Total, serious adverse events | 20 / 50 | 3 / 50 |
Outcome results
Primary
Hemostasis Success
Hemostasis at the puncture site within 10 minutes of cutting the MANTA suture without need for manual or mechanical compression and without later re-bleeding (trivial or subcutaneous oozing will not be considered bleeding; light finger pressure to control subcutaneous oozing will not be considered manual compression)
Time frame: Within the first 10 minutes of cutting the MANTA suture
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MANTA Vascular Closure Device (Total) | Hemostasis Success | 47 Participants |
| 14F MANTA Device | Hemostasis Success | 16 Participants |
| 18F MANTA Device | Hemostasis Success | 31 Participants |
Primary
Number of Participants With 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)
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MANTA Vascular Closure Device (Total) | Number of Participants With Major Complications | 3 Participants |
Secondary
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 frame: Time between MANTA deployment and first observed and confirmed arterial hemostasis up to ten (10) minutes after MANTA device is deployed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MANTA Vascular Closure Device (Total) | Time to Hemostasis | 2.38 minutes | Standard Deviation 6.63 |