Clinical trial NCT05142566: MANTA Ultrasound Closure Study
Official title: Prospective Multicenter MANTA™ Vascular Closure Device Ultrasound Guided Closure Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Femoral Arteriotomy Closure
Keywords: MANTA
Arterial Closure Device
Ultrasound Closure
Large Bore Closure Device
Lead sponsor: Essential Medical, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Teleflex
First posted: 2021-12-02
Enrollment: 17
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of Any Large Bore Access-site Related VARC-2 Major Vascular Complication
timeFrame: within 30 days
Secondary outcomes:
measure: Time to Hemostasis
timeFrame: During the procedure
measure: Number of Patients With Technical Success
timeFrame: within 30 days
measure: Number of Subjects With Ambulation Success
timeFrame: During procedure admission
measure: Time to Ambulation
timeFrame: During procedure admission
measure: Treatment Success
timeFrame: within 30 days
measure: Procedure Time
timeFrame: During the procedure
measure: Rate of Any Large Bore Access-site Related VARC-2 Minor Vascular Complication
timeFrame: within 30 days
Other outcomes:
Locations:
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Detroit
country: United States
facility: Henry Ford
state: Michigan
city: Buffalo
country: United States
facility: University of Buffalo
state: New York
city: Round Rock
country: United States
facility: Baylor Scott & White
state: Texas
city: Woodbridge
country: United States
facility: Sentara Northern Virginia Medical Center
state: Virginia
city: Vancouver
country: Canada
facility: Vancouver General Health
state: British Columbia
Study officials:
affiliation: Vancouver General Hospital
name: David Wood
role: PRINCIPAL_INVESTIGATOR
affiliation: University at Buffalo
name: Vijay Iyer
role: PRINCIPAL_INVESTIGATOR
References: