Femoral Arteriotomy Closure
Conditions
Keywords
MANTA, Arterial Closure Device, Ultrasound Closure, Large Bore Closure Device
Brief summary
Demonstrate the safety of MANTA Vascular Closure Device (VCD) ultrasound (U/S) guided closure in patients undergoing elective TAVR procedures with planned percutaneous femoral arterial access.
Detailed description
The MANTA Vascular Closure Device is indicated for closure of femoral arterial access sites while reducing time to hemostasis following the use of 10-20F devices or sheaths (12-25F OD) in endovascular catheterization procedures. This study is being conducted to demonstrate the safety of U/S guided closure with MANTA VCD following TAVR procedures utilizing large bore sheaths.
Interventions
Evaluate the safety of ultrasound guided deployment of MANTA VCD.
Sponsors
Teleflex
Essential Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
None (Open Label)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Candidate for elective or planned (i.e., not emergent or urgent) percutaneous transcatheter valve replacement (TAVR) via a 10-20F device or sheath (12-25F OD) with common femoral artery approach * Vessel size would allow for access for the MANTA VCD based on vessel size as determined by baseline CTA: minimum vessel diameter of 5mm for the 14F MANTA VCD and 6mm for the 18F MANTA VCD * Understand and sign the study specific written informed consent form and PHI authorization * Able and willing to fulfill the follow-up requirements
Exclusion criteria
* Patients known to be pregnant or lactating * Patients who have a systemic infection or a local infection at or near the access site * Patients with significant anemia (hemoglobin ≤10 g/DL) * Patients who are morbidly obese or cachectic (BMI \>40 or \<20kg/m2) * Patients with a known bleeding disorder including thrombocytopenia (platelet count \<100,000 cells/UL), thrombasthenia, hemophilia, or von Willebrand disease * Patients with allergy to bovine materials or any other device material, including collagen and/or collagen products, polyglycolic or polylactic acid, stainless steel or nickel * Patients with a femoral artery puncture in target groin within the prior 30 days, prior vascular closure device placement in the target common femoral artery within 3 months, or any prior target femoral artery access-related complication * Patients who have undergone use of an intra-aortic balloon pump (IABP) through the arterial access site within 30 days prior to the baseline evaluation. * Patients who have a Common Femoral Artery (CFA) with visible calcium and/or tortuosity, as determined by baseline CTA, precluding safe access and likely to interact with large bore access site arteriotomy, determined by investigator. * Patients with 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 in whom oral anticoagulation therapy cannot be stopped for the peri procedural period or patients with INR \>1.8 at the time of the procedure * Patients who are unable to ambulate at least 6 meters without assistance at baseline * Patients with renal insufficiency (serum creatinine \>2.5 mg/dl) or on dialysis therapy * Patients with existing nerve damage in the ipsilateral leg * Patients with a further planned endovascular procedure within the next 30 days * Patients who have already participated in this IDE study * Patients who are currently participating in another clinical study of an unapproved investigational device or drug that has not concluded the follow-up period or patient currently participating in another clinical study likely to influence hemostasis and vascular complications * Patients who cannot adhere to or complete the investigational protocol for any reason including but not limited to geographical residence, psychiatric condition or life threatening disease * Patients who have a common femoral artery \<5mm in diameter for the 14F MANTA VCD or \<6 mm in diameter for the 18F MANTA VCD, common femoral artery stenosis resulting in a vessel diameter \<5mm in diameter for the 14F MANTA VCD or \<6 mm in diameter for the 18F MANTA VCD, or \> 50% diameter femoral or iliac artery stenosis * Patients in whom, during initial access of the artery, arteriotomy and surrounding anatomy cannot be visualized and identified clearly under U/S imaging and/or if the vertical depth from the surface of the skin to target area of the common femoral artery measures greater than 6cm
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Any Large Bore Access-site Related VARC-2 Major Vascular Complication | within 30 days | adapted from VARC-2 Criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Technical Success | within 30 days | Percutaneous vascular closure is obtained without the use of unplanned endovascular or surgical intervention. |
| Number of Subjects With Ambulation Success | During procedure admission | If a previously ambulatory patient (until day of TAVI) is able to ambulate for at least 20 feet/6 meters without re-bleeding. |
| Time to Ambulation | During procedure admission | The elapsed time between VCD deployment and when ambulation is achieved. |
| Time to Hemostasis | During the procedure | The elapsed time between VCD deployment and first observed and confirmed arterial hemostasis. |
| Procedure Time | During the procedure | Elapsed time from initial skin break to time when the post-deployment angiogram is completed. |
| Rate of Any Large Bore Access-site Related VARC-2 Minor Vascular Complication | within 30 days | adapted from VARC-2 Criteria |
| Treatment Success | within 30 days | Time to Hemostasis ≤10 minutes and no VACR-2 Major complications |
Countries
Canada, United States
Participant flow
Recruitment details
one subject was treated by a physician who was not officially trained and signed off on the protocol or device.
Participants by arm
| Arm | Count |
|---|---|
| Ultrasound Closure Open label, single arm study using ultrasound guidance during MANTA device deployment.
MANTA Vascular Closure Device: Evaluate the safety of ultrasound guided deployment of MANTA VCD. | 17 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 1 |
Baseline characteristics
| Characteristic | Ultrasound Closure |
|---|---|
| Age, Continuous | 80.06 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 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 | 14 Participants |
| Region of Enrollment Canada | 11 participants |
| Region of Enrollment United States | 6 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 17 |
| other Total, other adverse events | 4 / 17 |
| serious Total, serious adverse events | 2 / 17 |
Outcome results
Primary
Rate of Any Large Bore Access-site Related VARC-2 Major Vascular Complication
adapted from VARC-2 Criteria
Time frame: within 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ultrasound Closure | Rate of Any Large Bore Access-site Related VARC-2 Major Vascular Complication | 0 Participants |
Secondary
Number of Patients With Technical Success
Percutaneous vascular closure is obtained without the use of unplanned endovascular or surgical intervention.
Time frame: within 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ultrasound Closure | Number of Patients With Technical Success | 17 Participants |
Secondary
Number of Subjects With Ambulation Success
If a previously ambulatory patient (until day of TAVI) is able to ambulate for at least 20 feet/6 meters without re-bleeding.
Time frame: During procedure admission
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ultrasound Closure | Number of Subjects With Ambulation Success | 17 Participants |
Secondary
Procedure Time
Elapsed time from initial skin break to time when the post-deployment angiogram is completed.
Time frame: During the procedure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ultrasound Closure | Procedure Time | 0.75 Hours |
Secondary
Rate of Any Large Bore Access-site Related VARC-2 Minor Vascular Complication
adapted from VARC-2 Criteria
Time frame: within 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ultrasound Closure | Rate of Any Large Bore Access-site Related VARC-2 Minor Vascular Complication | 1 Participants |
Secondary
Time to Ambulation
The elapsed time between VCD deployment and when ambulation is achieved.
Time frame: During procedure admission
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ultrasound Closure | Time to Ambulation | 8.93 hours |
Secondary
Time to Hemostasis
The elapsed time between VCD deployment and first observed and confirmed arterial hemostasis.
Time frame: During the procedure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ultrasound Closure | Time to Hemostasis | .42 Minutes |
Secondary
Treatment Success
Time to Hemostasis ≤10 minutes and no VACR-2 Major complications
Time frame: within 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ultrasound Closure | Treatment Success | 17 Participants |